Kari Oakes

Updated Zika virus figures from the U.S. territory of Puerto Rico show that more than two dozen locally acquired cases have occurred since December 2015, and more can be expected, according to the Centers for Disease Control and Prevention.

In a Feb. 12 report published in the Morbidity and Mortality Weekly Report, CDC officials said, “Because the most common mosquito vector of Zika virus, Aedes aegypti, is present throughout Puerto Rico, Zika virus is expected to continue to spread throughout the island.”

During the period of Nov. 23, 2015, to Jan. 28, 2016, the Puerto Rico Department of Health (PRDH) reported a total of 30 laboratory-confirmed cases of Zika virus. The first locally acquired case of Zika virus in Puerto Rico was reported on Dec. 31, 2015, in a patient from the southeastern region (Morb Mortal Wkly Rep. 2016 Feb;65[early release]:1-6. doi: http://dx.doi.org/10.15585/mmwr.mm6506e2er.).

The PRDH is using passive and enhanced surveillance to track the spread of the mosquito-borne Flavivirus, a disease that in humans has a generally benign course but that has a suspected association with microcephaly in infants born to Zika-infected mothers. Investigators are also tracking a suspected association with Guillain-Barré syndrome.

Patients, who mainly resided in metropolitan San Juan or areas of eastern Puerto Rico, had mostly mild illness. Patients most frequently experienced rash (77%), myalgia (77%), arthralgia (73%), and fever (73%). Three patients were hospitalized.

One case of Guillain-Barré syndrome in a Zika-infected individual was reported to the PRDH, but the department saw no cases of microcephaly that were suspected of being associated with Zika virus.

The CDC is coordinating with the PRDH in ongoing surveillance efforts and response to the Zika virus. All clinicians in Puerto Rico are urged to report cases of Guillain-Barré syndrome, microcephaly, and suspected Zika infection to the PRDH. Residents of Puerto Rico should use strict mosquito avoidance and bite prevention measures, including the use of window screens, protective clothing, and an effective insect repellent.

[email protected]

On Twitter @karioakes

Updated Zika virus figures from the U.S. territory of Puerto Rico show that more than two dozen locally acquired cases have occurred since December 2015, and more can be expected, according to the Centers for Disease Control and Prevention.

In a Feb. 12 report published in the Morbidity and Mortality Weekly Report, CDC officials said, “Because the most common mosquito vector of Zika virus, Aedes aegypti, is present throughout Puerto Rico, Zika virus is expected to continue to spread throughout the island.”

During the period of Nov. 23, 2015, to Jan. 28, 2016, the Puerto Rico Department of Health (PRDH) reported a total of 30 laboratory-confirmed cases of Zika virus. The first locally acquired case of Zika virus in Puerto Rico was reported on Dec. 31, 2015, in a patient from the southeastern region (Morb Mortal Wkly Rep. 2016 Feb;65[early release]:1-6. doi: http://dx.doi.org/10.15585/mmwr.mm6506e2er.).

The PRDH is using passive and enhanced surveillance to track the spread of the mosquito-borne Flavivirus, a disease that in humans has a generally benign course but that has a suspected association with microcephaly in infants born to Zika-infected mothers. Investigators are also tracking a suspected association with Guillain-Barré syndrome.

Patients, who mainly resided in metropolitan San Juan or areas of eastern Puerto Rico, had mostly mild illness. Patients most frequently experienced rash (77%), myalgia (77%), arthralgia (73%), and fever (73%). Three patients were hospitalized.

One case of Guillain-Barré syndrome in a Zika-infected individual was reported to the PRDH, but the department saw no cases of microcephaly that were suspected of being associated with Zika virus.

The CDC is coordinating with the PRDH in ongoing surveillance efforts and response to the Zika virus. All clinicians in Puerto Rico are urged to report cases of Guillain-Barré syndrome, microcephaly, and suspected Zika infection to the PRDH. Residents of Puerto Rico should use strict mosquito avoidance and bite prevention measures, including the use of window screens, protective clothing, and an effective insect repellent.

[email protected]

On Twitter @karioakes

Updated Zika virus figures from the U.S. territory of Puerto Rico show that more than two dozen locally acquired cases have occurred since December 2015, and more can be expected, according to the Centers for Disease Control and Prevention.

In a Feb. 12 report published in the Morbidity and Mortality Weekly Report, CDC officials said, “Because the most common mosquito vector of Zika virus, Aedes aegypti, is present throughout Puerto Rico, Zika virus is expected to continue to spread throughout the island.”

During the period of Nov. 23, 2015, to Jan. 28, 2016, the Puerto Rico Department of Health (PRDH) reported a total of 30 laboratory-confirmed cases of Zika virus. The first locally acquired case of Zika virus in Puerto Rico was reported on Dec. 31, 2015, in a patient from the southeastern region (Morb Mortal Wkly Rep. 2016 Feb;65[early release]:1-6. doi: http://dx.doi.org/10.15585/mmwr.mm6506e2er.).

The PRDH is using passive and enhanced surveillance to track the spread of the mosquito-borne Flavivirus, a disease that in humans has a generally benign course but that has a suspected association with microcephaly in infants born to Zika-infected mothers. Investigators are also tracking a suspected association with Guillain-Barré syndrome.

Patients, who mainly resided in metropolitan San Juan or areas of eastern Puerto Rico, had mostly mild illness. Patients most frequently experienced rash (77%), myalgia (77%), arthralgia (73%), and fever (73%). Three patients were hospitalized.

One case of Guillain-Barré syndrome in a Zika-infected individual was reported to the PRDH, but the department saw no cases of microcephaly that were suspected of being associated with Zika virus.

The CDC is coordinating with the PRDH in ongoing surveillance efforts and response to the Zika virus. All clinicians in Puerto Rico are urged to report cases of Guillain-Barré syndrome, microcephaly, and suspected Zika infection to the PRDH. Residents of Puerto Rico should use strict mosquito avoidance and bite prevention measures, including the use of window screens, protective clothing, and an effective insect repellent.

[email protected]

On Twitter @karioakes

HOLLYWOOD, FLA. – Many physicians use microfocused ultrasound (MFU-V) or other energy devices along with neurotoxins and injectable fillers, but how these therapies should be sequenced, and how closely they can be grouped, remains an open question. One physician’s look at his own and colleagues’ data found a surprising answer: it doesn’t seem to matter.

“We have had this ongoing debate for years and years on when you should use an energy device, on when you should inject a toxin, on when you should inject a filler – and maybe more importantly, on when you shouldn’t use a toxin or a filler in proximity to the energy device,” said Dr. Phillip Werschler, a cosmetic surgeon in private practice in Spokane, Wash.

There are theoretical concerns that applying heat energy to recently placed fillers or neurotoxins may alter the protein structure of the injected material, and also about injecting skin recently treated by ultrasound or other energy-based therapies, Dr. Werschler said at the annual meeting of the American Academy of Cosmetic Surgery.

Citing a paucity of evidence for best practices, Dr. Werschler and his colleagues conducted a small retrospective study – a multicenter chart review – to examine whether microfocused ultrasound (MFU-V) is safe when used within 6 months of the administration of neurotoxins and/or dermal fillers.

The study’s primary outcome measure was the incidence of adverse events in patients who were treated with both MFU-V and toxins or fillers within 6 months’ proximity. Dr. Werschler and his colleagues examined the charts of 101 patients who had received MFU-V and either a neurotoxin or a dermal filler in the previous 2 years, and for whom the injectable therapy was administered within 6 months of the energy-based treatment. “One subject did not provide gender data. 101 subjects were enrolled. 4 males, 96 females, & 1 without gender provided.”

Men and women aged 25-70 years were included in the review. Mean age was 55.3 years (range, 32-72); 4 males, and 96 females were enrolled (gender information was not provided for one patient).

All 101 patients received MFU-V treatments, with transducer depth during treatment at 1.5 mm (n = 69 treatments), 3.0 mm (n = 99), or 4.5 mm (n = 84). Some patients received treatments in more than one area, so 48 subjects received a full-face treatment, 58 received neck treatment, 45 received partial facial or other area treatment, and 7 received décolleté treatment.

Filler treatment was administered to 83 subjects, with 57 of those (69%) receiving hyaluronic acid, and 26 (31%) receiving calcium hydroxylapatite. Depth of injection varied: 59 areas had intradermal injections, 56 had subdermal injections, and 11 injections targeted the periosteal layer.

Of the 83 patients receiving fillers, 16 received MFU-V on the same treatment day, and one patient had neurotoxin.

Twenty patients received neurotoxin treatment at the muscle (48 areas) and intradermal (10 areas) layers. Of these, four also received MFU-V on the same day.

The majority of patients treated with multiple modalities received toxin or filler within 90 days before or after the MFU-V treatment (n = 48 for filler + MFU-V and n = 12 for filler + toxin).

Of the 101 enrollees, seven patients each had one adverse event. Four of these events resolved without sequelae, while the outcomes for the other three are unknown. Most of the adverse events were mild bruising, purpura, or swelling; one patient had a herpes simplex virus outbreak, one patient had paresthesias, and one patient reported moderate bruising and swelling.

“What we didn’t see is … for example, granuloma formation in those patients that were treated previously with a filler, either a particulate or a natural filler, and then heat energy was applied over it in the form of microfocused ultrasound. We didn’t see melting of the fillers.”

The retrospective chart review supports the safety of combination treatments, said Dr. Werschler. “So what does all this mean to your practice? It’s another piece of evidence – a small piece – that it’s OK to put energy over toxins and fillers,” said Dr. Werschler.

Dr. Werschler disclosed that he is a consultant, investigator and speaker for Ulthera, a division of Merz Aesthetics. He did not receive compensation for this study.

[email protected]

On Twitter @karioakes

HOLLYWOOD, FLA. – Many physicians use microfocused ultrasound (MFU-V) or other energy devices along with neurotoxins and injectable fillers, but how these therapies should be sequenced, and how closely they can be grouped, remains an open question. One physician’s look at his own and colleagues’ data found a surprising answer: it doesn’t seem to matter.

“We have had this ongoing debate for years and years on when you should use an energy device, on when you should inject a toxin, on when you should inject a filler – and maybe more importantly, on when you shouldn’t use a toxin or a filler in proximity to the energy device,” said Dr. Phillip Werschler, a cosmetic surgeon in private practice in Spokane, Wash.

There are theoretical concerns that applying heat energy to recently placed fillers or neurotoxins may alter the protein structure of the injected material, and also about injecting skin recently treated by ultrasound or other energy-based therapies, Dr. Werschler said at the annual meeting of the American Academy of Cosmetic Surgery.

Citing a paucity of evidence for best practices, Dr. Werschler and his colleagues conducted a small retrospective study – a multicenter chart review – to examine whether microfocused ultrasound (MFU-V) is safe when used within 6 months of the administration of neurotoxins and/or dermal fillers.

The study’s primary outcome measure was the incidence of adverse events in patients who were treated with both MFU-V and toxins or fillers within 6 months’ proximity. Dr. Werschler and his colleagues examined the charts of 101 patients who had received MFU-V and either a neurotoxin or a dermal filler in the previous 2 years, and for whom the injectable therapy was administered within 6 months of the energy-based treatment. “One subject did not provide gender data. 101 subjects were enrolled. 4 males, 96 females, & 1 without gender provided.”

Men and women aged 25-70 years were included in the review. Mean age was 55.3 years (range, 32-72); 4 males, and 96 females were enrolled (gender information was not provided for one patient).

All 101 patients received MFU-V treatments, with transducer depth during treatment at 1.5 mm (n = 69 treatments), 3.0 mm (n = 99), or 4.5 mm (n = 84). Some patients received treatments in more than one area, so 48 subjects received a full-face treatment, 58 received neck treatment, 45 received partial facial or other area treatment, and 7 received décolleté treatment.

Filler treatment was administered to 83 subjects, with 57 of those (69%) receiving hyaluronic acid, and 26 (31%) receiving calcium hydroxylapatite. Depth of injection varied: 59 areas had intradermal injections, 56 had subdermal injections, and 11 injections targeted the periosteal layer.

Of the 83 patients receiving fillers, 16 received MFU-V on the same treatment day, and one patient had neurotoxin.

Twenty patients received neurotoxin treatment at the muscle (48 areas) and intradermal (10 areas) layers. Of these, four also received MFU-V on the same day.

The majority of patients treated with multiple modalities received toxin or filler within 90 days before or after the MFU-V treatment (n = 48 for filler + MFU-V and n = 12 for filler + toxin).

Of the 101 enrollees, seven patients each had one adverse event. Four of these events resolved without sequelae, while the outcomes for the other three are unknown. Most of the adverse events were mild bruising, purpura, or swelling; one patient had a herpes simplex virus outbreak, one patient had paresthesias, and one patient reported moderate bruising and swelling.

“What we didn’t see is … for example, granuloma formation in those patients that were treated previously with a filler, either a particulate or a natural filler, and then heat energy was applied over it in the form of microfocused ultrasound. We didn’t see melting of the fillers.”

The retrospective chart review supports the safety of combination treatments, said Dr. Werschler. “So what does all this mean to your practice? It’s another piece of evidence – a small piece – that it’s OK to put energy over toxins and fillers,” said Dr. Werschler.

Dr. Werschler disclosed that he is a consultant, investigator and speaker for Ulthera, a division of Merz Aesthetics. He did not receive compensation for this study.

[email protected]

On Twitter @karioakes

HOLLYWOOD, FLA. – Many physicians use microfocused ultrasound (MFU-V) or other energy devices along with neurotoxins and injectable fillers, but how these therapies should be sequenced, and how closely they can be grouped, remains an open question. One physician’s look at his own and colleagues’ data found a surprising answer: it doesn’t seem to matter.

“We have had this ongoing debate for years and years on when you should use an energy device, on when you should inject a toxin, on when you should inject a filler – and maybe more importantly, on when you shouldn’t use a toxin or a filler in proximity to the energy device,” said Dr. Phillip Werschler, a cosmetic surgeon in private practice in Spokane, Wash.

There are theoretical concerns that applying heat energy to recently placed fillers or neurotoxins may alter the protein structure of the injected material, and also about injecting skin recently treated by ultrasound or other energy-based therapies, Dr. Werschler said at the annual meeting of the American Academy of Cosmetic Surgery.

Citing a paucity of evidence for best practices, Dr. Werschler and his colleagues conducted a small retrospective study – a multicenter chart review – to examine whether microfocused ultrasound (MFU-V) is safe when used within 6 months of the administration of neurotoxins and/or dermal fillers.

The study’s primary outcome measure was the incidence of adverse events in patients who were treated with both MFU-V and toxins or fillers within 6 months’ proximity. Dr. Werschler and his colleagues examined the charts of 101 patients who had received MFU-V and either a neurotoxin or a dermal filler in the previous 2 years, and for whom the injectable therapy was administered within 6 months of the energy-based treatment. “One subject did not provide gender data. 101 subjects were enrolled. 4 males, 96 females, & 1 without gender provided.”

Men and women aged 25-70 years were included in the review. Mean age was 55.3 years (range, 32-72); 4 males, and 96 females were enrolled (gender information was not provided for one patient).

All 101 patients received MFU-V treatments, with transducer depth during treatment at 1.5 mm (n = 69 treatments), 3.0 mm (n = 99), or 4.5 mm (n = 84). Some patients received treatments in more than one area, so 48 subjects received a full-face treatment, 58 received neck treatment, 45 received partial facial or other area treatment, and 7 received décolleté treatment.

Filler treatment was administered to 83 subjects, with 57 of those (69%) receiving hyaluronic acid, and 26 (31%) receiving calcium hydroxylapatite. Depth of injection varied: 59 areas had intradermal injections, 56 had subdermal injections, and 11 injections targeted the periosteal layer.

Of the 83 patients receiving fillers, 16 received MFU-V on the same treatment day, and one patient had neurotoxin.

Twenty patients received neurotoxin treatment at the muscle (48 areas) and intradermal (10 areas) layers. Of these, four also received MFU-V on the same day.

The majority of patients treated with multiple modalities received toxin or filler within 90 days before or after the MFU-V treatment (n = 48 for filler + MFU-V and n = 12 for filler + toxin).

Of the 101 enrollees, seven patients each had one adverse event. Four of these events resolved without sequelae, while the outcomes for the other three are unknown. Most of the adverse events were mild bruising, purpura, or swelling; one patient had a herpes simplex virus outbreak, one patient had paresthesias, and one patient reported moderate bruising and swelling.

“What we didn’t see is … for example, granuloma formation in those patients that were treated previously with a filler, either a particulate or a natural filler, and then heat energy was applied over it in the form of microfocused ultrasound. We didn’t see melting of the fillers.”

The retrospective chart review supports the safety of combination treatments, said Dr. Werschler. “So what does all this mean to your practice? It’s another piece of evidence – a small piece – that it’s OK to put energy over toxins and fillers,” said Dr. Werschler.

Dr. Werschler disclosed that he is a consultant, investigator and speaker for Ulthera, a division of Merz Aesthetics. He did not receive compensation for this study.

[email protected]

On Twitter @karioakes

In updated guidance, the U.S. Centers for Disease Control and Prevention advised pregnant women to use condoms or abstain from sex with men who have traveled to Zika-infected areas. The CDC also expanded Zika testing recommendations to advise testing all pregnant women who have traveled to Zika-infected areas, regardless of whether they have symptoms of Zika virus infection.

The CDC also now recommends that pregnant women postpone travel to Zika-infected areas.

© CDC

Precautions to avoid potential sexual transmission of Zika virus follow a report earlier this week of sexual transmission of Zika virus from an individual who had traveled to a Zika-infected area, to that person’s sexual partner, who had not traveled to a Zika-infected area. The recommendation to consistently and correctly use condoms, or to abstain from sex, includes oral, anal, and vaginal insertive sex (MMWR Morb Mortal Wkly Rep. 2016 Feb 5;65[5]:1-2).

In a telebriefing, CDC director Dr. Tom Frieden said, “Because this phenomenon is so new, we are quite literally discovering more about it every day.”

The mosquito-borne flavivirus may be associated with an increased risk of microcephaly and other intracranial and neurologic abnormalities in infants whose mothers were infected with Zika virus during pregnancy. A possible link to Guillain-Barré syndrome is also being explored.

Zika virus infection is asymptomatic in 80% of individuals. Symptoms of infection, if they appear, include initial fever, a maculopapular rash, arthralgia, and sometimes conjunctivitis. There is no treatment for the disease and care is supportive.

Women who have traveled to an area with active Zika virus transmission but who have not shown symptoms of Zika virus should now be offered testing, if available, between 2 and 12 weeks from the travel date.

Testing for women who show symptoms consistent with Zika virus disease should include Zika virus reverse transcription polymerase chain reaction, Zika virus Immunoglobulin M (IgM), and neutralizing antibodies on serum specimens. Patients should also be evaluated for dengue and chikungunya virus infection because of the overlap in symptoms and endemic regions for the diseases. For those women who are pregnant and have traveled to a Zika-infected area, but who do not have symptoms of Zika infection, testing should include Zika virus IgM and, for positive or inconclusive IgM tests, neutralizing antibodies on serum specimens (MMWR Morb Mortal Wkly Rep. 2016 Feb 5;65[05]:1-6).

Dr. Frieden said that the CDC was working around the clock to make more test kits available, and is in active discussion with private manufacturers to expand production of test kits.

Brazilian researchers have issued a brief report that Zika virus has been found in urine and saliva, but Dr. Frieden clarified that today’s updated guidance does not address having women avoid exposure to urine or saliva of infected or potentially infected individuals. “We have no data on that, and we try to stick to the science here at the CDC,” he said, so current guidelines don’t address other modes of transmission, though study is ongoing. A focus of current study is to determine how long the virus persists in semen, though Dr. Frieden said it will take “weeks to months to come up with reliable information.”

Dr. Amesh A. Adalja, a member of the public health committee of the Infectious Disease Society of America and an instructor in the department of infectious diseases at the University of Pittsburgh Medical Center, said in an interview that new and emerging information about previously unknown Zika virus presentations “doesn’t change what we do know.” For most, he said, this is an asymptomatic to very mild, self-limiting disease. However, Dr. Adalja said, “We need to unravel the microcephaly link.” He called for case control studies to determine definitively if microcephaly is a “real signal” in Zika virus infection.

“It is important to step back and emphasize that Zika virus is overwhelmingly a mosquito-borne disease,” said Dr. Frieden. He said that the broader public health effort must focus on mosquito control. “The Aedes aegypti mosquito is an aggressive mosquito. It is ideally suited to the urban environment,” and the mosquito bites four or five people at one blood meal, and feeds throughout the day, not just at dawn and dusk, said Dr. Frieden. He emphasized that mosquito control measures are labor intensive and technically demanding. “This is not easy work,” he said.

Dr. Frieden said that the situation is rapidly evolving, and the CDC will continue sharing information as it becomes available. “Zika reminds us that nature is a formidable enemy,” he said.

[email protected]

On Twitter @karioakes

In updated guidance, the U.S. Centers for Disease Control and Prevention advised pregnant women to use condoms or abstain from sex with men who have traveled to Zika-infected areas. The CDC also expanded Zika testing recommendations to advise testing all pregnant women who have traveled to Zika-infected areas, regardless of whether they have symptoms of Zika virus infection.

The CDC also now recommends that pregnant women postpone travel to Zika-infected areas.

© CDC

Precautions to avoid potential sexual transmission of Zika virus follow a report earlier this week of sexual transmission of Zika virus from an individual who had traveled to a Zika-infected area, to that person’s sexual partner, who had not traveled to a Zika-infected area. The recommendation to consistently and correctly use condoms, or to abstain from sex, includes oral, anal, and vaginal insertive sex (MMWR Morb Mortal Wkly Rep. 2016 Feb 5;65[5]:1-2).

In a telebriefing, CDC director Dr. Tom Frieden said, “Because this phenomenon is so new, we are quite literally discovering more about it every day.”

The mosquito-borne flavivirus may be associated with an increased risk of microcephaly and other intracranial and neurologic abnormalities in infants whose mothers were infected with Zika virus during pregnancy. A possible link to Guillain-Barré syndrome is also being explored.

Zika virus infection is asymptomatic in 80% of individuals. Symptoms of infection, if they appear, include initial fever, a maculopapular rash, arthralgia, and sometimes conjunctivitis. There is no treatment for the disease and care is supportive.

Women who have traveled to an area with active Zika virus transmission but who have not shown symptoms of Zika virus should now be offered testing, if available, between 2 and 12 weeks from the travel date.

Testing for women who show symptoms consistent with Zika virus disease should include Zika virus reverse transcription polymerase chain reaction, Zika virus Immunoglobulin M (IgM), and neutralizing antibodies on serum specimens. Patients should also be evaluated for dengue and chikungunya virus infection because of the overlap in symptoms and endemic regions for the diseases. For those women who are pregnant and have traveled to a Zika-infected area, but who do not have symptoms of Zika infection, testing should include Zika virus IgM and, for positive or inconclusive IgM tests, neutralizing antibodies on serum specimens (MMWR Morb Mortal Wkly Rep. 2016 Feb 5;65[05]:1-6).

Dr. Frieden said that the CDC was working around the clock to make more test kits available, and is in active discussion with private manufacturers to expand production of test kits.

Brazilian researchers have issued a brief report that Zika virus has been found in urine and saliva, but Dr. Frieden clarified that today’s updated guidance does not address having women avoid exposure to urine or saliva of infected or potentially infected individuals. “We have no data on that, and we try to stick to the science here at the CDC,” he said, so current guidelines don’t address other modes of transmission, though study is ongoing. A focus of current study is to determine how long the virus persists in semen, though Dr. Frieden said it will take “weeks to months to come up with reliable information.”

Dr. Amesh A. Adalja, a member of the public health committee of the Infectious Disease Society of America and an instructor in the department of infectious diseases at the University of Pittsburgh Medical Center, said in an interview that new and emerging information about previously unknown Zika virus presentations “doesn’t change what we do know.” For most, he said, this is an asymptomatic to very mild, self-limiting disease. However, Dr. Adalja said, “We need to unravel the microcephaly link.” He called for case control studies to determine definitively if microcephaly is a “real signal” in Zika virus infection.

“It is important to step back and emphasize that Zika virus is overwhelmingly a mosquito-borne disease,” said Dr. Frieden. He said that the broader public health effort must focus on mosquito control. “The Aedes aegypti mosquito is an aggressive mosquito. It is ideally suited to the urban environment,” and the mosquito bites four or five people at one blood meal, and feeds throughout the day, not just at dawn and dusk, said Dr. Frieden. He emphasized that mosquito control measures are labor intensive and technically demanding. “This is not easy work,” he said.

Dr. Frieden said that the situation is rapidly evolving, and the CDC will continue sharing information as it becomes available. “Zika reminds us that nature is a formidable enemy,” he said.

[email protected]

On Twitter @karioakes

In updated guidance, the U.S. Centers for Disease Control and Prevention advised pregnant women to use condoms or abstain from sex with men who have traveled to Zika-infected areas. The CDC also expanded Zika testing recommendations to advise testing all pregnant women who have traveled to Zika-infected areas, regardless of whether they have symptoms of Zika virus infection.

The CDC also now recommends that pregnant women postpone travel to Zika-infected areas.

© CDC

Precautions to avoid potential sexual transmission of Zika virus follow a report earlier this week of sexual transmission of Zika virus from an individual who had traveled to a Zika-infected area, to that person’s sexual partner, who had not traveled to a Zika-infected area. The recommendation to consistently and correctly use condoms, or to abstain from sex, includes oral, anal, and vaginal insertive sex (MMWR Morb Mortal Wkly Rep. 2016 Feb 5;65[5]:1-2).

In a telebriefing, CDC director Dr. Tom Frieden said, “Because this phenomenon is so new, we are quite literally discovering more about it every day.”

The mosquito-borne flavivirus may be associated with an increased risk of microcephaly and other intracranial and neurologic abnormalities in infants whose mothers were infected with Zika virus during pregnancy. A possible link to Guillain-Barré syndrome is also being explored.

Zika virus infection is asymptomatic in 80% of individuals. Symptoms of infection, if they appear, include initial fever, a maculopapular rash, arthralgia, and sometimes conjunctivitis. There is no treatment for the disease and care is supportive.

Women who have traveled to an area with active Zika virus transmission but who have not shown symptoms of Zika virus should now be offered testing, if available, between 2 and 12 weeks from the travel date.

Testing for women who show symptoms consistent with Zika virus disease should include Zika virus reverse transcription polymerase chain reaction, Zika virus Immunoglobulin M (IgM), and neutralizing antibodies on serum specimens. Patients should also be evaluated for dengue and chikungunya virus infection because of the overlap in symptoms and endemic regions for the diseases. For those women who are pregnant and have traveled to a Zika-infected area, but who do not have symptoms of Zika infection, testing should include Zika virus IgM and, for positive or inconclusive IgM tests, neutralizing antibodies on serum specimens (MMWR Morb Mortal Wkly Rep. 2016 Feb 5;65[05]:1-6).

Dr. Frieden said that the CDC was working around the clock to make more test kits available, and is in active discussion with private manufacturers to expand production of test kits.

Brazilian researchers have issued a brief report that Zika virus has been found in urine and saliva, but Dr. Frieden clarified that today’s updated guidance does not address having women avoid exposure to urine or saliva of infected or potentially infected individuals. “We have no data on that, and we try to stick to the science here at the CDC,” he said, so current guidelines don’t address other modes of transmission, though study is ongoing. A focus of current study is to determine how long the virus persists in semen, though Dr. Frieden said it will take “weeks to months to come up with reliable information.”

Dr. Amesh A. Adalja, a member of the public health committee of the Infectious Disease Society of America and an instructor in the department of infectious diseases at the University of Pittsburgh Medical Center, said in an interview that new and emerging information about previously unknown Zika virus presentations “doesn’t change what we do know.” For most, he said, this is an asymptomatic to very mild, self-limiting disease. However, Dr. Adalja said, “We need to unravel the microcephaly link.” He called for case control studies to determine definitively if microcephaly is a “real signal” in Zika virus infection.

“It is important to step back and emphasize that Zika virus is overwhelmingly a mosquito-borne disease,” said Dr. Frieden. He said that the broader public health effort must focus on mosquito control. “The Aedes aegypti mosquito is an aggressive mosquito. It is ideally suited to the urban environment,” and the mosquito bites four or five people at one blood meal, and feeds throughout the day, not just at dawn and dusk, said Dr. Frieden. He emphasized that mosquito control measures are labor intensive and technically demanding. “This is not easy work,” he said.

Dr. Frieden said that the situation is rapidly evolving, and the CDC will continue sharing information as it becomes available. “Zika reminds us that nature is a formidable enemy,” he said.

[email protected]

On Twitter @karioakes

An advisory panel of the Food and Drug Administration on Feb. 3 supported vortioxetine for the treatment of cognitive dysfunction associated with major depressive disorder.

The 8-2 approval vote of the FDA’s Psychopharmacologic Drugs Advisory Committee sets the stage for Takeda Pharmaceuticals, which markets vortioxetine (Brintellix) in the United States, to seek a change in prescribing information for the antidepressant, which already is approved to treat major depressive disorder (MDD).

Though it’s long been known that MDD is associated with cognitive dysfunction for many patients, no drug has yet been approved specifically to improve cognitive function in those suffering from depression. Dr. Tiffany Farchione, acting deputy director of the division of psychiatry products at the FDA, observed that the psychiatric community is still working to define treatment goals and outcome measures for cognitive dysfunction in MDD. “This came to us before we were quite ready,” she said of Takeda’s application for the new labeling for vortioxetine.

The possible utility of vortioxetine for alleviating cognitive dysfunction in MDD came from an exploratory clinical trial, termed ELDERLY, whose predetermined endpoints included measures of cognitive function. Since ELDERLY found significant improvement in cognitive function for vortioxetine, compared with both placebo and duloxetine for patients with MDD, two further pivotal clinical trials were conducted to address the question of efficacy for cognitive function.

The FOCUS pivotal clinical trial enrolled 602 adult patients with MDD. The 8-week, double blind, randomized trial randomized patients 1:1:1 to vortioxetine 10 or 20 mg or placebo. At the end of the trial, both doses of vortioxetine resulted in better improvement than placebo on a composite score of cognitive dysfunction (mean treatment effects of 0.36 for 10 mg and 0.33 for 20 mg, both P less than .0001). Further statistical analysis showed this effect to be largely independent of improvement in depressive symptoms.

The CONNECT pivotal clinical trial added a direct comparator, duloxetine (Cymbalta), to the mix. It also enrolled 604 adults with MDD and lasted 8 weeks, and found that patients on vortioxetine got significantly better scores on the Digit Single Substitution Test (DSST) than did those on placebo (P less than .05). In addition, the results showed significant improvement, compared with patients on placebo, on two objective functional measures designed to assess functioning in the real world.

Vortioxetine is a selective serotonin reuptake inhibitor that also may have direct action on serotonin receptors. According to the prescribing information, “The contribution of these activities to vortioxetine ’s antidepressant effect has not been established.” Recommended doses are 10 mg or 20 mg once daily.

A complementary morning session of the advisory committee was devoted to assessing whether cognitive dysfunction in MDD is an appropriate drug target and, if so, how best to assess cognition in MDD. One area of vigorous discussion remaining unresolved at the end of the morning’s talks was whether a functional assessment, in addition to neuropsychological testing, should be a required coprimary endpoint. There were no voting items for the morning session.

Panel members also weighed whether the DSST was a single measure that could assess cognitive dysfunction in MDD. Takeda’s discussion of the DSST emphasized that it correlated well with other items in a more extensive neuropsychological test battery, and that improvement on the DSST also correlated with some objective measures of function. From a practical standpoint, it can be administered in the office in a matter of minutes.

Some committee members wrestled with using a single brief test as a proxy for the nuances of human cognition. However, Dr. Murray Stein, professor of psychiatry and family & preventive medicine at the University of California, San Diego, voiced a position shared by many panelists: “Given the circumstances where the company was trying to pick a single cognitive measure, this was a good choice.”

The FDA usually takes the advice of its advisory panels.

[email protected]

On Twitter @karioakes

An advisory panel of the Food and Drug Administration on Feb. 3 supported vortioxetine for the treatment of cognitive dysfunction associated with major depressive disorder.

The 8-2 approval vote of the FDA’s Psychopharmacologic Drugs Advisory Committee sets the stage for Takeda Pharmaceuticals, which markets vortioxetine (Brintellix) in the United States, to seek a change in prescribing information for the antidepressant, which already is approved to treat major depressive disorder (MDD).

Though it’s long been known that MDD is associated with cognitive dysfunction for many patients, no drug has yet been approved specifically to improve cognitive function in those suffering from depression. Dr. Tiffany Farchione, acting deputy director of the division of psychiatry products at the FDA, observed that the psychiatric community is still working to define treatment goals and outcome measures for cognitive dysfunction in MDD. “This came to us before we were quite ready,” she said of Takeda’s application for the new labeling for vortioxetine.

The possible utility of vortioxetine for alleviating cognitive dysfunction in MDD came from an exploratory clinical trial, termed ELDERLY, whose predetermined endpoints included measures of cognitive function. Since ELDERLY found significant improvement in cognitive function for vortioxetine, compared with both placebo and duloxetine for patients with MDD, two further pivotal clinical trials were conducted to address the question of efficacy for cognitive function.

The FOCUS pivotal clinical trial enrolled 602 adult patients with MDD. The 8-week, double blind, randomized trial randomized patients 1:1:1 to vortioxetine 10 or 20 mg or placebo. At the end of the trial, both doses of vortioxetine resulted in better improvement than placebo on a composite score of cognitive dysfunction (mean treatment effects of 0.36 for 10 mg and 0.33 for 20 mg, both P less than .0001). Further statistical analysis showed this effect to be largely independent of improvement in depressive symptoms.

The CONNECT pivotal clinical trial added a direct comparator, duloxetine (Cymbalta), to the mix. It also enrolled 604 adults with MDD and lasted 8 weeks, and found that patients on vortioxetine got significantly better scores on the Digit Single Substitution Test (DSST) than did those on placebo (P less than .05). In addition, the results showed significant improvement, compared with patients on placebo, on two objective functional measures designed to assess functioning in the real world.

Vortioxetine is a selective serotonin reuptake inhibitor that also may have direct action on serotonin receptors. According to the prescribing information, “The contribution of these activities to vortioxetine ’s antidepressant effect has not been established.” Recommended doses are 10 mg or 20 mg once daily.

A complementary morning session of the advisory committee was devoted to assessing whether cognitive dysfunction in MDD is an appropriate drug target and, if so, how best to assess cognition in MDD. One area of vigorous discussion remaining unresolved at the end of the morning’s talks was whether a functional assessment, in addition to neuropsychological testing, should be a required coprimary endpoint. There were no voting items for the morning session.

Panel members also weighed whether the DSST was a single measure that could assess cognitive dysfunction in MDD. Takeda’s discussion of the DSST emphasized that it correlated well with other items in a more extensive neuropsychological test battery, and that improvement on the DSST also correlated with some objective measures of function. From a practical standpoint, it can be administered in the office in a matter of minutes.

Some committee members wrestled with using a single brief test as a proxy for the nuances of human cognition. However, Dr. Murray Stein, professor of psychiatry and family & preventive medicine at the University of California, San Diego, voiced a position shared by many panelists: “Given the circumstances where the company was trying to pick a single cognitive measure, this was a good choice.”

The FDA usually takes the advice of its advisory panels.

[email protected]

On Twitter @karioakes

An advisory panel of the Food and Drug Administration on Feb. 3 supported vortioxetine for the treatment of cognitive dysfunction associated with major depressive disorder.

The 8-2 approval vote of the FDA’s Psychopharmacologic Drugs Advisory Committee sets the stage for Takeda Pharmaceuticals, which markets vortioxetine (Brintellix) in the United States, to seek a change in prescribing information for the antidepressant, which already is approved to treat major depressive disorder (MDD).

Though it’s long been known that MDD is associated with cognitive dysfunction for many patients, no drug has yet been approved specifically to improve cognitive function in those suffering from depression. Dr. Tiffany Farchione, acting deputy director of the division of psychiatry products at the FDA, observed that the psychiatric community is still working to define treatment goals and outcome measures for cognitive dysfunction in MDD. “This came to us before we were quite ready,” she said of Takeda’s application for the new labeling for vortioxetine.

The possible utility of vortioxetine for alleviating cognitive dysfunction in MDD came from an exploratory clinical trial, termed ELDERLY, whose predetermined endpoints included measures of cognitive function. Since ELDERLY found significant improvement in cognitive function for vortioxetine, compared with both placebo and duloxetine for patients with MDD, two further pivotal clinical trials were conducted to address the question of efficacy for cognitive function.

The FOCUS pivotal clinical trial enrolled 602 adult patients with MDD. The 8-week, double blind, randomized trial randomized patients 1:1:1 to vortioxetine 10 or 20 mg or placebo. At the end of the trial, both doses of vortioxetine resulted in better improvement than placebo on a composite score of cognitive dysfunction (mean treatment effects of 0.36 for 10 mg and 0.33 for 20 mg, both P less than .0001). Further statistical analysis showed this effect to be largely independent of improvement in depressive symptoms.

The CONNECT pivotal clinical trial added a direct comparator, duloxetine (Cymbalta), to the mix. It also enrolled 604 adults with MDD and lasted 8 weeks, and found that patients on vortioxetine got significantly better scores on the Digit Single Substitution Test (DSST) than did those on placebo (P less than .05). In addition, the results showed significant improvement, compared with patients on placebo, on two objective functional measures designed to assess functioning in the real world.

Vortioxetine is a selective serotonin reuptake inhibitor that also may have direct action on serotonin receptors. According to the prescribing information, “The contribution of these activities to vortioxetine ’s antidepressant effect has not been established.” Recommended doses are 10 mg or 20 mg once daily.

A complementary morning session of the advisory committee was devoted to assessing whether cognitive dysfunction in MDD is an appropriate drug target and, if so, how best to assess cognition in MDD. One area of vigorous discussion remaining unresolved at the end of the morning’s talks was whether a functional assessment, in addition to neuropsychological testing, should be a required coprimary endpoint. There were no voting items for the morning session.

Panel members also weighed whether the DSST was a single measure that could assess cognitive dysfunction in MDD. Takeda’s discussion of the DSST emphasized that it correlated well with other items in a more extensive neuropsychological test battery, and that improvement on the DSST also correlated with some objective measures of function. From a practical standpoint, it can be administered in the office in a matter of minutes.

Some committee members wrestled with using a single brief test as a proxy for the nuances of human cognition. However, Dr. Murray Stein, professor of psychiatry and family & preventive medicine at the University of California, San Diego, voiced a position shared by many panelists: “Given the circumstances where the company was trying to pick a single cognitive measure, this was a good choice.”

The FDA usually takes the advice of its advisory panels.

[email protected]

On Twitter @karioakes

HOLLYWOOD, FL. – Pick the right patient, set realistic expectations, and use a cautious technique for the best result with deoxycholic acid, advised Joe Niamtu, DMD, a cosmetic facial surgeon in private practice in Midlothian, Va.

Speaking at the annual meeting of the American Academy of Cosmetic Surgery, Dr. Niamtu shared tips and techniques for best results using deoxycholic acid (Kybella) injection for reduction of submental fat, based on several months of real world use since it was approved in 2015.

Deoxycholic acid, a bile acid, causes breakdown of adipocytes when injected into fatty tissue. Since the resulting dissolution of fat cells is permanent, once the desired aesthetic effect is achieved, retreatment should not be needed, he said.

Currently, deoxycholic acid injection is only approved for the treatment of submental fat. Dr. Niamtu reviewed results of the pivotal phase III clinical trials for this indication, which characterized 68.2% of those receiving deoxycholic acid as treatment responders, compared with 20.5% of patients receiving placebo injections. Response was assessed by validated physician and patient assessment measures.

In clinical trials, the most common side effects were edema, hematoma, and pain, as well as numbness, erythema, and induration.

Whether it makes sense for an individual practice to offer deoxycholic acid injections “depends on the flavor of your practice,” Dr. Niamtu said. “I have a surgical practice, and my patients expect a big bang,” so only a limited number of his patients would be attracted to this procedure. By contrast, in a minimally invasive practice, this procedure might be more popular.

Overall, deoxycholic acid is an attractive option for patients who wish to avoid surgical procedures but still are seeking modest improvement in submental fat, he said. “It all depends what kind of practice you have, what kind of patients you attract, what their expectations are.”

The components of a youthful and fit-appearing neckline include a distinct mandibular border and subhyoid depression, a visible thyroid cartilage bulge, a visible anterior sternocleidomastoid line, and the cervicomental angle.

“There’s one thing about youth, and it’s that nice, defined cervicomental angle,” said Dr. Niamtu. “It’s important to understand what a youthful neck is, because that’s your endpoint.” When a double chin” appears, that angle droops and a crisp profile is lost.

Appropriate candidates for deoxycholic injection are “young people that have isolated fat deposits without skin excess,” said Dr. Niamtu. “If you inject Kybella into somebody who has a lot of extra skin, and they get a bad result, this stuff can come back to haunt you,” he said, recommending not to “sugar-coat predicted results and recovery.”

“When you are dealing with fat…there are some things you have to monitor,” he pointed out. He recommended taking very careful before and after pictures, and also weighing patients and calculating body mass index at each session. He also recommended taking pictures while the patient is smiling and puckering, to identify any preexisting paresis or asymmetry.

When injecting deoxycholic acid, the target is the preplatysmal fat of the submental triangle. “You’ve got to know where to put this stuff. The marginal mandibular nerve is vulnerable,” Dr. Niamtu observed. It can be tempting to treat the jowl, he said, but it’s important to give the nerve a wide margin, especially at a point about 2 cm lateral to the oral commissure, because that’s where the marginal mandibular nerve’s course becomes quite superficial.

“When you’re anterior to the mandibular notch, that nerve runs close to the mandibular border,” he said, noting that a number of mandibular nerve palsies were caused during the trials of deoxycholic acid. The resulting paresis gives an asymmetric smile, with less depression of the lower lip on the affected side since the depressor anguli oris and depressor labii are affected. In clinical trials, all episodes of paresis resolved spontaneously after a mean of 44 days.

To identify the targeted fat tissue, the operator can pinch the submental fat, or have the patient clench his or her teeth or tense the platysma. Though some apply topical anesthesia before deoxycholic acid injection, Dr. Niamtu, who uses a 32 gauge needle, does not. He prefers to use 2% lidocaine with epinephrine once the deoxycholic acid is going in and starts to burn, in order to avoid obscuring the fat target while planning the injection, and also to minimize any possibility of diluting the deoxycholic acid.

The product comes a wettable template that transfers a temporary tattoo of injection sites to the submental triangle, with 1 cm spacing between the dots to indicate where to inject. Each site receives 0.2 mL of deoxycholic acid. The mandibular border is marked, and another line is drawn about a finger breadth below the mandibular border. This second line forms the outer bound of the injection area. “That’s our no-fly zone. We don’t want to inject there. That’s where the marginal mandibular nerve lives,” said Dr. Niamtu.

He uses about 4-6 mL of deoxycholic acid per patient session. In treatment planning, the dose can be calculated once the tattoo is applied, multiplying the number of dots within the treatment zone by 0.2 mL per site. It’s important to remember to stay superficial when injecting, a technique that’s different than that used in many other injectables, Dr. Niamtu said.

Patients experience swelling, so they should be prepared for significant edema and submental fullness and some discomfort, bruising, and numbness in the few days after the procedure. However, Dr. Niamtu said all of his patients have been able to return to work the next day.

In clinical trials, most patients received two to four treatment sessions, which can get expensive for the patient, he said. “I could do a facelift for what it’s going to cost sometimes.”

Dr. Niamtu is a trainer for Allergan, the manufacturer of Kybella.

[email protected]

On Twitter @karioakes

HOLLYWOOD, FL. – Pick the right patient, set realistic expectations, and use a cautious technique for the best result with deoxycholic acid, advised Joe Niamtu, DMD, a cosmetic facial surgeon in private practice in Midlothian, Va.

Speaking at the annual meeting of the American Academy of Cosmetic Surgery, Dr. Niamtu shared tips and techniques for best results using deoxycholic acid (Kybella) injection for reduction of submental fat, based on several months of real world use since it was approved in 2015.

Deoxycholic acid, a bile acid, causes breakdown of adipocytes when injected into fatty tissue. Since the resulting dissolution of fat cells is permanent, once the desired aesthetic effect is achieved, retreatment should not be needed, he said.

Currently, deoxycholic acid injection is only approved for the treatment of submental fat. Dr. Niamtu reviewed results of the pivotal phase III clinical trials for this indication, which characterized 68.2% of those receiving deoxycholic acid as treatment responders, compared with 20.5% of patients receiving placebo injections. Response was assessed by validated physician and patient assessment measures.

In clinical trials, the most common side effects were edema, hematoma, and pain, as well as numbness, erythema, and induration.

Whether it makes sense for an individual practice to offer deoxycholic acid injections “depends on the flavor of your practice,” Dr. Niamtu said. “I have a surgical practice, and my patients expect a big bang,” so only a limited number of his patients would be attracted to this procedure. By contrast, in a minimally invasive practice, this procedure might be more popular.

Overall, deoxycholic acid is an attractive option for patients who wish to avoid surgical procedures but still are seeking modest improvement in submental fat, he said. “It all depends what kind of practice you have, what kind of patients you attract, what their expectations are.”

The components of a youthful and fit-appearing neckline include a distinct mandibular border and subhyoid depression, a visible thyroid cartilage bulge, a visible anterior sternocleidomastoid line, and the cervicomental angle.

“There’s one thing about youth, and it’s that nice, defined cervicomental angle,” said Dr. Niamtu. “It’s important to understand what a youthful neck is, because that’s your endpoint.” When a double chin” appears, that angle droops and a crisp profile is lost.

Appropriate candidates for deoxycholic injection are “young people that have isolated fat deposits without skin excess,” said Dr. Niamtu. “If you inject Kybella into somebody who has a lot of extra skin, and they get a bad result, this stuff can come back to haunt you,” he said, recommending not to “sugar-coat predicted results and recovery.”

“When you are dealing with fat…there are some things you have to monitor,” he pointed out. He recommended taking very careful before and after pictures, and also weighing patients and calculating body mass index at each session. He also recommended taking pictures while the patient is smiling and puckering, to identify any preexisting paresis or asymmetry.

When injecting deoxycholic acid, the target is the preplatysmal fat of the submental triangle. “You’ve got to know where to put this stuff. The marginal mandibular nerve is vulnerable,” Dr. Niamtu observed. It can be tempting to treat the jowl, he said, but it’s important to give the nerve a wide margin, especially at a point about 2 cm lateral to the oral commissure, because that’s where the marginal mandibular nerve’s course becomes quite superficial.

“When you’re anterior to the mandibular notch, that nerve runs close to the mandibular border,” he said, noting that a number of mandibular nerve palsies were caused during the trials of deoxycholic acid. The resulting paresis gives an asymmetric smile, with less depression of the lower lip on the affected side since the depressor anguli oris and depressor labii are affected. In clinical trials, all episodes of paresis resolved spontaneously after a mean of 44 days.

To identify the targeted fat tissue, the operator can pinch the submental fat, or have the patient clench his or her teeth or tense the platysma. Though some apply topical anesthesia before deoxycholic acid injection, Dr. Niamtu, who uses a 32 gauge needle, does not. He prefers to use 2% lidocaine with epinephrine once the deoxycholic acid is going in and starts to burn, in order to avoid obscuring the fat target while planning the injection, and also to minimize any possibility of diluting the deoxycholic acid.

The product comes a wettable template that transfers a temporary tattoo of injection sites to the submental triangle, with 1 cm spacing between the dots to indicate where to inject. Each site receives 0.2 mL of deoxycholic acid. The mandibular border is marked, and another line is drawn about a finger breadth below the mandibular border. This second line forms the outer bound of the injection area. “That’s our no-fly zone. We don’t want to inject there. That’s where the marginal mandibular nerve lives,” said Dr. Niamtu.

He uses about 4-6 mL of deoxycholic acid per patient session. In treatment planning, the dose can be calculated once the tattoo is applied, multiplying the number of dots within the treatment zone by 0.2 mL per site. It’s important to remember to stay superficial when injecting, a technique that’s different than that used in many other injectables, Dr. Niamtu said.

Patients experience swelling, so they should be prepared for significant edema and submental fullness and some discomfort, bruising, and numbness in the few days after the procedure. However, Dr. Niamtu said all of his patients have been able to return to work the next day.

In clinical trials, most patients received two to four treatment sessions, which can get expensive for the patient, he said. “I could do a facelift for what it’s going to cost sometimes.”

Dr. Niamtu is a trainer for Allergan, the manufacturer of Kybella.

[email protected]

On Twitter @karioakes

HOLLYWOOD, FL. – Pick the right patient, set realistic expectations, and use a cautious technique for the best result with deoxycholic acid, advised Joe Niamtu, DMD, a cosmetic facial surgeon in private practice in Midlothian, Va.

Speaking at the annual meeting of the American Academy of Cosmetic Surgery, Dr. Niamtu shared tips and techniques for best results using deoxycholic acid (Kybella) injection for reduction of submental fat, based on several months of real world use since it was approved in 2015.

Deoxycholic acid, a bile acid, causes breakdown of adipocytes when injected into fatty tissue. Since the resulting dissolution of fat cells is permanent, once the desired aesthetic effect is achieved, retreatment should not be needed, he said.

Currently, deoxycholic acid injection is only approved for the treatment of submental fat. Dr. Niamtu reviewed results of the pivotal phase III clinical trials for this indication, which characterized 68.2% of those receiving deoxycholic acid as treatment responders, compared with 20.5% of patients receiving placebo injections. Response was assessed by validated physician and patient assessment measures.

In clinical trials, the most common side effects were edema, hematoma, and pain, as well as numbness, erythema, and induration.

Whether it makes sense for an individual practice to offer deoxycholic acid injections “depends on the flavor of your practice,” Dr. Niamtu said. “I have a surgical practice, and my patients expect a big bang,” so only a limited number of his patients would be attracted to this procedure. By contrast, in a minimally invasive practice, this procedure might be more popular.

Overall, deoxycholic acid is an attractive option for patients who wish to avoid surgical procedures but still are seeking modest improvement in submental fat, he said. “It all depends what kind of practice you have, what kind of patients you attract, what their expectations are.”

The components of a youthful and fit-appearing neckline include a distinct mandibular border and subhyoid depression, a visible thyroid cartilage bulge, a visible anterior sternocleidomastoid line, and the cervicomental angle.

“There’s one thing about youth, and it’s that nice, defined cervicomental angle,” said Dr. Niamtu. “It’s important to understand what a youthful neck is, because that’s your endpoint.” When a double chin” appears, that angle droops and a crisp profile is lost.

Appropriate candidates for deoxycholic injection are “young people that have isolated fat deposits without skin excess,” said Dr. Niamtu. “If you inject Kybella into somebody who has a lot of extra skin, and they get a bad result, this stuff can come back to haunt you,” he said, recommending not to “sugar-coat predicted results and recovery.”

“When you are dealing with fat…there are some things you have to monitor,” he pointed out. He recommended taking very careful before and after pictures, and also weighing patients and calculating body mass index at each session. He also recommended taking pictures while the patient is smiling and puckering, to identify any preexisting paresis or asymmetry.

When injecting deoxycholic acid, the target is the preplatysmal fat of the submental triangle. “You’ve got to know where to put this stuff. The marginal mandibular nerve is vulnerable,” Dr. Niamtu observed. It can be tempting to treat the jowl, he said, but it’s important to give the nerve a wide margin, especially at a point about 2 cm lateral to the oral commissure, because that’s where the marginal mandibular nerve’s course becomes quite superficial.

“When you’re anterior to the mandibular notch, that nerve runs close to the mandibular border,” he said, noting that a number of mandibular nerve palsies were caused during the trials of deoxycholic acid. The resulting paresis gives an asymmetric smile, with less depression of the lower lip on the affected side since the depressor anguli oris and depressor labii are affected. In clinical trials, all episodes of paresis resolved spontaneously after a mean of 44 days.

To identify the targeted fat tissue, the operator can pinch the submental fat, or have the patient clench his or her teeth or tense the platysma. Though some apply topical anesthesia before deoxycholic acid injection, Dr. Niamtu, who uses a 32 gauge needle, does not. He prefers to use 2% lidocaine with epinephrine once the deoxycholic acid is going in and starts to burn, in order to avoid obscuring the fat target while planning the injection, and also to minimize any possibility of diluting the deoxycholic acid.

The product comes a wettable template that transfers a temporary tattoo of injection sites to the submental triangle, with 1 cm spacing between the dots to indicate where to inject. Each site receives 0.2 mL of deoxycholic acid. The mandibular border is marked, and another line is drawn about a finger breadth below the mandibular border. This second line forms the outer bound of the injection area. “That’s our no-fly zone. We don’t want to inject there. That’s where the marginal mandibular nerve lives,” said Dr. Niamtu.

He uses about 4-6 mL of deoxycholic acid per patient session. In treatment planning, the dose can be calculated once the tattoo is applied, multiplying the number of dots within the treatment zone by 0.2 mL per site. It’s important to remember to stay superficial when injecting, a technique that’s different than that used in many other injectables, Dr. Niamtu said.

Patients experience swelling, so they should be prepared for significant edema and submental fullness and some discomfort, bruising, and numbness in the few days after the procedure. However, Dr. Niamtu said all of his patients have been able to return to work the next day.

In clinical trials, most patients received two to four treatment sessions, which can get expensive for the patient, he said. “I could do a facelift for what it’s going to cost sometimes.”

Dr. Niamtu is a trainer for Allergan, the manufacturer of Kybella.

[email protected]

On Twitter @karioakes

Hepatitis B infection more than doubled in three Appalachian states from 2006-2013, with significant increases among those aged 30-39, injection drug users, and non-Hispanic whites, according to a study published Jan. 28 in MMWR.

“A hepatitis B epidemic is emerging in Kentucky, Tennessee, and West Virginia,” according to Dr. Aaron Harris of the division of viral hepatitis at the Centers for Disease Control and Prevention and his coauthors.

A total of 3,305 cases of acute HBV infection in the three states were reported to the National Notifiable Diseases Surveillance System (NNDSS) between 2009 and 2013. The proportion of those with HBV who reported injection drug use was significantly higher during the period from 2010-2013 than during the 2005-2009 time frame (75% vs. 53%, P less than .001).

Characteristics that significantly increased the likelihood of an individual having HBV infection included being 30-39 years, being non-Hispanic white, and being an injection drug user (all P less than .001). Sex was not a significant differentiator, and full demographic and drug use data were not available for all reported cases (MMWR Morb Mortal Wkly Rep. 2016:65;47-50).

The rise in HBV infections was statistically significant in non-urban counties, but not in urban counties (P less than .001 for trend).

This large regional increase in acute HBV infection is in contrast to stable HBV infection rates in the U.S., with an overall rate of 1 case in 100,000 in 2013. Though the vaccination is effective at preventing HBV infection, two-thirds of Americans aged 19-49 years are not fully vaccinated.

Hepatitis B vaccination has been part of the childhood immunization series since 1991, and has been recommended for children aged 18 and younger since 1999, so adults aged 33 years and older at the end of the study period would not have received HBV immunization routinely.

“The concurrent increase in reports of acute HBV and HCV infections, as well as an increase in injection drug use reported among this population is concerning,” wrote Dr. Harris and his coauthors, who added that hospital admissions for prescription opioid abuse increased by 17.1% and for heroin use by 7.4% in the three states during the study period.

The authors noted several study limitations, many of which may have resulted in under-reporting of the true incidence of HBV. The study data come from a passive surveillance system, and the case definition only includes those whose disease is symptomatic. Additionally, individuals who are high risk and underserved by the health care system may be missed.

Kentucky, West Virginia, and Tennessee are using a variety of strategies to target at-risk populations, according to the report, including partnering with jails and prisons to increase vaccination rates among incarcerated individuals, reaching out to those who run rehabilitation and harm reduction services, and mandating reporting of HBV infection in pregnant women and young children.

“Evidence-based prevention strategies, including increasing hepatitis B vaccination coverage, testing and linkage to care, and implementing education campaigns that target persons who inject drugs are urgently needed,” Dr. Harris and his coauthors wrote.

[email protected]

On Twitter @karioakes

Hepatitis B infection more than doubled in three Appalachian states from 2006-2013, with significant increases among those aged 30-39, injection drug users, and non-Hispanic whites, according to a study published Jan. 28 in MMWR.

“A hepatitis B epidemic is emerging in Kentucky, Tennessee, and West Virginia,” according to Dr. Aaron Harris of the division of viral hepatitis at the Centers for Disease Control and Prevention and his coauthors.

A total of 3,305 cases of acute HBV infection in the three states were reported to the National Notifiable Diseases Surveillance System (NNDSS) between 2009 and 2013. The proportion of those with HBV who reported injection drug use was significantly higher during the period from 2010-2013 than during the 2005-2009 time frame (75% vs. 53%, P less than .001).

Characteristics that significantly increased the likelihood of an individual having HBV infection included being 30-39 years, being non-Hispanic white, and being an injection drug user (all P less than .001). Sex was not a significant differentiator, and full demographic and drug use data were not available for all reported cases (MMWR Morb Mortal Wkly Rep. 2016:65;47-50).

The rise in HBV infections was statistically significant in non-urban counties, but not in urban counties (P less than .001 for trend).

This large regional increase in acute HBV infection is in contrast to stable HBV infection rates in the U.S., with an overall rate of 1 case in 100,000 in 2013. Though the vaccination is effective at preventing HBV infection, two-thirds of Americans aged 19-49 years are not fully vaccinated.

Hepatitis B vaccination has been part of the childhood immunization series since 1991, and has been recommended for children aged 18 and younger since 1999, so adults aged 33 years and older at the end of the study period would not have received HBV immunization routinely.

“The concurrent increase in reports of acute HBV and HCV infections, as well as an increase in injection drug use reported among this population is concerning,” wrote Dr. Harris and his coauthors, who added that hospital admissions for prescription opioid abuse increased by 17.1% and for heroin use by 7.4% in the three states during the study period.

The authors noted several study limitations, many of which may have resulted in under-reporting of the true incidence of HBV. The study data come from a passive surveillance system, and the case definition only includes those whose disease is symptomatic. Additionally, individuals who are high risk and underserved by the health care system may be missed.

Kentucky, West Virginia, and Tennessee are using a variety of strategies to target at-risk populations, according to the report, including partnering with jails and prisons to increase vaccination rates among incarcerated individuals, reaching out to those who run rehabilitation and harm reduction services, and mandating reporting of HBV infection in pregnant women and young children.

“Evidence-based prevention strategies, including increasing hepatitis B vaccination coverage, testing and linkage to care, and implementing education campaigns that target persons who inject drugs are urgently needed,” Dr. Harris and his coauthors wrote.

[email protected]

On Twitter @karioakes

Hepatitis B infection more than doubled in three Appalachian states from 2006-2013, with significant increases among those aged 30-39, injection drug users, and non-Hispanic whites, according to a study published Jan. 28 in MMWR.

“A hepatitis B epidemic is emerging in Kentucky, Tennessee, and West Virginia,” according to Dr. Aaron Harris of the division of viral hepatitis at the Centers for Disease Control and Prevention and his coauthors.

A total of 3,305 cases of acute HBV infection in the three states were reported to the National Notifiable Diseases Surveillance System (NNDSS) between 2009 and 2013. The proportion of those with HBV who reported injection drug use was significantly higher during the period from 2010-2013 than during the 2005-2009 time frame (75% vs. 53%, P less than .001).

Characteristics that significantly increased the likelihood of an individual having HBV infection included being 30-39 years, being non-Hispanic white, and being an injection drug user (all P less than .001). Sex was not a significant differentiator, and full demographic and drug use data were not available for all reported cases (MMWR Morb Mortal Wkly Rep. 2016:65;47-50).

The rise in HBV infections was statistically significant in non-urban counties, but not in urban counties (P less than .001 for trend).

This large regional increase in acute HBV infection is in contrast to stable HBV infection rates in the U.S., with an overall rate of 1 case in 100,000 in 2013. Though the vaccination is effective at preventing HBV infection, two-thirds of Americans aged 19-49 years are not fully vaccinated.

Hepatitis B vaccination has been part of the childhood immunization series since 1991, and has been recommended for children aged 18 and younger since 1999, so adults aged 33 years and older at the end of the study period would not have received HBV immunization routinely.

“The concurrent increase in reports of acute HBV and HCV infections, as well as an increase in injection drug use reported among this population is concerning,” wrote Dr. Harris and his coauthors, who added that hospital admissions for prescription opioid abuse increased by 17.1% and for heroin use by 7.4% in the three states during the study period.

The authors noted several study limitations, many of which may have resulted in under-reporting of the true incidence of HBV. The study data come from a passive surveillance system, and the case definition only includes those whose disease is symptomatic. Additionally, individuals who are high risk and underserved by the health care system may be missed.

Kentucky, West Virginia, and Tennessee are using a variety of strategies to target at-risk populations, according to the report, including partnering with jails and prisons to increase vaccination rates among incarcerated individuals, reaching out to those who run rehabilitation and harm reduction services, and mandating reporting of HBV infection in pregnant women and young children.

“Evidence-based prevention strategies, including increasing hepatitis B vaccination coverage, testing and linkage to care, and implementing education campaigns that target persons who inject drugs are urgently needed,” Dr. Harris and his coauthors wrote.

[email protected]

On Twitter @karioakes

All adults, including pregnant and postpartum women, should be screened for depression, according to new recommendations of the U.S. Preventive Services Task Force.

The recommendation also calls for screening to be coupled with “adequate systems” to ensure diagnosis, treatment, and follow-up (JAMA. 2016 Jan 26;315[4]:380-7).

The depression screening recommendation, authored by Dr. Albert L. Siu and the other members of the USPSTF, is a level B recommendation, meaning that it has either high certainty of moderate net benefit, or moderate certainty of moderate to substantial net benefit.

The new guidance in screening for depression helps address a disorder that is “the leading cause of disability among adults in high-income countries,” said Dr. Siu and his coauthors. Lost productivity attributable to depression cost $23 billion in the United States in 2011, and $22.8 billion was spent on treatments for depression in 2009, the last year for which figures are available.

Dr. Siu, chair of geriatrics and palliative medicine at Icahn School of Medicine at Mount Sinai, New York, and his coauthors cited “convincing evidence that screening improves the accurate identification of adult patients with depression in primary care settings, including pregnant and postpartum women.”

In addition, the task force found convincing evidence that for older adults as well as the general adult population, treatment of “depression identified through screening in primary care settings with antidepressants, psychotherapy, or both decreases clinical morbidity.”

For pregnant and postpartum women with depression, Dr. Siu and his coauthors found “adequate” evidence that cognitive behavioral therapy (CBT) improves outcomes.

The recommendation does not identify optimal timing and intervals for depression screening, citing a need for more research in this area. However, “a pragmatic approach might include screening all adults who have not been screened previously and using clinical judgment in consideration of risk factors, comorbid conditions, and life events to determine if additional screening of high-risk patients is warranted,” explained Dr. Siu and his coauthors.

The new depression screening recommendation from USPSTF updates the 2009 recommendation, which recommended universal screening if “staff-assisted depression care supports” were in place, and targeted screening based on clinical judgment and patient preference if such support were unavailable.

The rationale for the current recommendation of universal screening for those 18 years and older is the “recognition that such support is now much more widely available and accepted as part of mental health care,” the task force members said.

Any potential harms of screening, said Dr. Siu and his coauthors, were minimal to nonexistent.

Overall, the USPSTF assigned a small to moderate risk to the use of medication in depression. However, the use of “second-generation” antidepressants – mostly SSRIs – was associated with some harms, including increased risk of suicidal behavior in young adults and of gastrointestinal bleeding in older adults, as well as potential fetal harms in pregnant women taking antidepressants.

Using CBT to treat depression in pregnant and postpartum women was also associated with minimal to no harm.

The USPSTF screening recommendation is aligned with the American Academy of Family Physicians’ recommendation to screen the general adult population for depression, and with the American Academy of Pediatrics’ recommendation that pediatricians screen mothers for depression at their babies’ 1-, 2-, and 4-month office visits.

Released in draft form in July 2015, the depression screening recommendation was available for public comment for a period of 4 weeks. In response to public input, the final recommendation’s implementation section clarifies and characterizes an “adequate system” of screening, and gives more resources for evidence-based depression screening and treatment.

The Agency for Healthcare Research and Quality supports the operations of the USPSTF, but the task force’s recommendations are independent of the federal government. Dr. Siu and the other task force members reported no conflicts of interest.

[email protected]

On Twitter @karioakes

All adults, including pregnant and postpartum women, should be screened for depression, according to new recommendations of the U.S. Preventive Services Task Force.

The recommendation also calls for screening to be coupled with “adequate systems” to ensure diagnosis, treatment, and follow-up (JAMA. 2016 Jan 26;315[4]:380-7).

The depression screening recommendation, authored by Dr. Albert L. Siu and the other members of the USPSTF, is a level B recommendation, meaning that it has either high certainty of moderate net benefit, or moderate certainty of moderate to substantial net benefit.

The new guidance in screening for depression helps address a disorder that is “the leading cause of disability among adults in high-income countries,” said Dr. Siu and his coauthors. Lost productivity attributable to depression cost $23 billion in the United States in 2011, and $22.8 billion was spent on treatments for depression in 2009, the last year for which figures are available.

Dr. Siu, chair of geriatrics and palliative medicine at Icahn School of Medicine at Mount Sinai, New York, and his coauthors cited “convincing evidence that screening improves the accurate identification of adult patients with depression in primary care settings, including pregnant and postpartum women.”

In addition, the task force found convincing evidence that for older adults as well as the general adult population, treatment of “depression identified through screening in primary care settings with antidepressants, psychotherapy, or both decreases clinical morbidity.”

For pregnant and postpartum women with depression, Dr. Siu and his coauthors found “adequate” evidence that cognitive behavioral therapy (CBT) improves outcomes.

The recommendation does not identify optimal timing and intervals for depression screening, citing a need for more research in this area. However, “a pragmatic approach might include screening all adults who have not been screened previously and using clinical judgment in consideration of risk factors, comorbid conditions, and life events to determine if additional screening of high-risk patients is warranted,” explained Dr. Siu and his coauthors.

The new depression screening recommendation from USPSTF updates the 2009 recommendation, which recommended universal screening if “staff-assisted depression care supports” were in place, and targeted screening based on clinical judgment and patient preference if such support were unavailable.

The rationale for the current recommendation of universal screening for those 18 years and older is the “recognition that such support is now much more widely available and accepted as part of mental health care,” the task force members said.

Any potential harms of screening, said Dr. Siu and his coauthors, were minimal to nonexistent.

Overall, the USPSTF assigned a small to moderate risk to the use of medication in depression. However, the use of “second-generation” antidepressants – mostly SSRIs – was associated with some harms, including increased risk of suicidal behavior in young adults and of gastrointestinal bleeding in older adults, as well as potential fetal harms in pregnant women taking antidepressants.

Using CBT to treat depression in pregnant and postpartum women was also associated with minimal to no harm.

The USPSTF screening recommendation is aligned with the American Academy of Family Physicians’ recommendation to screen the general adult population for depression, and with the American Academy of Pediatrics’ recommendation that pediatricians screen mothers for depression at their babies’ 1-, 2-, and 4-month office visits.

Released in draft form in July 2015, the depression screening recommendation was available for public comment for a period of 4 weeks. In response to public input, the final recommendation’s implementation section clarifies and characterizes an “adequate system” of screening, and gives more resources for evidence-based depression screening and treatment.

The Agency for Healthcare Research and Quality supports the operations of the USPSTF, but the task force’s recommendations are independent of the federal government. Dr. Siu and the other task force members reported no conflicts of interest.

[email protected]

On Twitter @karioakes

All adults, including pregnant and postpartum women, should be screened for depression, according to new recommendations of the U.S. Preventive Services Task Force.

The recommendation also calls for screening to be coupled with “adequate systems” to ensure diagnosis, treatment, and follow-up (JAMA. 2016 Jan 26;315[4]:380-7).

The depression screening recommendation, authored by Dr. Albert L. Siu and the other members of the USPSTF, is a level B recommendation, meaning that it has either high certainty of moderate net benefit, or moderate certainty of moderate to substantial net benefit.

The new guidance in screening for depression helps address a disorder that is “the leading cause of disability among adults in high-income countries,” said Dr. Siu and his coauthors. Lost productivity attributable to depression cost $23 billion in the United States in 2011, and $22.8 billion was spent on treatments for depression in 2009, the last year for which figures are available.

Dr. Siu, chair of geriatrics and palliative medicine at Icahn School of Medicine at Mount Sinai, New York, and his coauthors cited “convincing evidence that screening improves the accurate identification of adult patients with depression in primary care settings, including pregnant and postpartum women.”

In addition, the task force found convincing evidence that for older adults as well as the general adult population, treatment of “depression identified through screening in primary care settings with antidepressants, psychotherapy, or both decreases clinical morbidity.”

For pregnant and postpartum women with depression, Dr. Siu and his coauthors found “adequate” evidence that cognitive behavioral therapy (CBT) improves outcomes.

The recommendation does not identify optimal timing and intervals for depression screening, citing a need for more research in this area. However, “a pragmatic approach might include screening all adults who have not been screened previously and using clinical judgment in consideration of risk factors, comorbid conditions, and life events to determine if additional screening of high-risk patients is warranted,” explained Dr. Siu and his coauthors.

The new depression screening recommendation from USPSTF updates the 2009 recommendation, which recommended universal screening if “staff-assisted depression care supports” were in place, and targeted screening based on clinical judgment and patient preference if such support were unavailable.

The rationale for the current recommendation of universal screening for those 18 years and older is the “recognition that such support is now much more widely available and accepted as part of mental health care,” the task force members said.

Any potential harms of screening, said Dr. Siu and his coauthors, were minimal to nonexistent.

Overall, the USPSTF assigned a small to moderate risk to the use of medication in depression. However, the use of “second-generation” antidepressants – mostly SSRIs – was associated with some harms, including increased risk of suicidal behavior in young adults and of gastrointestinal bleeding in older adults, as well as potential fetal harms in pregnant women taking antidepressants.

Using CBT to treat depression in pregnant and postpartum women was also associated with minimal to no harm.

The USPSTF screening recommendation is aligned with the American Academy of Family Physicians’ recommendation to screen the general adult population for depression, and with the American Academy of Pediatrics’ recommendation that pediatricians screen mothers for depression at their babies’ 1-, 2-, and 4-month office visits.

Released in draft form in July 2015, the depression screening recommendation was available for public comment for a period of 4 weeks. In response to public input, the final recommendation’s implementation section clarifies and characterizes an “adequate system” of screening, and gives more resources for evidence-based depression screening and treatment.

The Agency for Healthcare Research and Quality supports the operations of the USPSTF, but the task force’s recommendations are independent of the federal government. Dr. Siu and the other task force members reported no conflicts of interest.

[email protected]

On Twitter @karioakes