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CDC reports first human case of H5 bird flu in the U.S.
A man who worked on a commercial poultry farm in Colorado has tested positive for avian influenza A(H5) virus, better known as H5 bird flu, the CDC announced on April 28.
This is the first case of H5 bird flu in humans in the United States and only the second case in the world, the CDC said in a news release. The first case was detected last December in a man who raised birds in the United Kingdom. That man had no symptoms.
The only symptom the man in Colorado reported was fatigue, the Colorado Department of Public Health and Environment (CDPHE) reported. He has recovered and is isolating and being treated with oseltamivir, an antiviral drug.
The CDC said the man was helping kill poultry that likely had the H5N1 bird flu.
He is a state prison inmate who was working on a commercial poultry farm in Montrose County in a prerelease employment program, the CDPHE said. The flock he was working with has been euthanized, and the response team and other inmates working on the farm were given protective equipment, the CDPHE said.
“Repeat testing on the person was negative for influenza,” the department said. “Because the person was in close contact with infected poultry, the virus may have been in the person’s nose without causing infection.”
This CDC said the case does not change the risk of bird flu for the general public, which is considered low. People who work with birds should continue to take safety precautions, such as wearing gloves when handling birds and avoiding birds that appear to be dead or ill, the CDC said.
“We want to reassure Coloradans that the risk to them is low,” said Rachel Herlihy, MD, state epidemiologist with the CDPHE. “I am grateful for the seamless collaboration between CDC, Department of Corrections, Department of Agriculture, and CDPHE, as we continue to monitor this virus and protect all Coloradans.”
The federal government says the H5N1 virus has been found in commercial and backyard birds in 29 states and in wild birds in 34 states since the first cases were detected in late 2021.
The CDC says it has tracked the health of 2,500 people exposed to birds infected with H5N1 and only found one case of human infection, in Colorado.
A version of this article first appeared on WebMD.com.
A man who worked on a commercial poultry farm in Colorado has tested positive for avian influenza A(H5) virus, better known as H5 bird flu, the CDC announced on April 28.
This is the first case of H5 bird flu in humans in the United States and only the second case in the world, the CDC said in a news release. The first case was detected last December in a man who raised birds in the United Kingdom. That man had no symptoms.
The only symptom the man in Colorado reported was fatigue, the Colorado Department of Public Health and Environment (CDPHE) reported. He has recovered and is isolating and being treated with oseltamivir, an antiviral drug.
The CDC said the man was helping kill poultry that likely had the H5N1 bird flu.
He is a state prison inmate who was working on a commercial poultry farm in Montrose County in a prerelease employment program, the CDPHE said. The flock he was working with has been euthanized, and the response team and other inmates working on the farm were given protective equipment, the CDPHE said.
“Repeat testing on the person was negative for influenza,” the department said. “Because the person was in close contact with infected poultry, the virus may have been in the person’s nose without causing infection.”
This CDC said the case does not change the risk of bird flu for the general public, which is considered low. People who work with birds should continue to take safety precautions, such as wearing gloves when handling birds and avoiding birds that appear to be dead or ill, the CDC said.
“We want to reassure Coloradans that the risk to them is low,” said Rachel Herlihy, MD, state epidemiologist with the CDPHE. “I am grateful for the seamless collaboration between CDC, Department of Corrections, Department of Agriculture, and CDPHE, as we continue to monitor this virus and protect all Coloradans.”
The federal government says the H5N1 virus has been found in commercial and backyard birds in 29 states and in wild birds in 34 states since the first cases were detected in late 2021.
The CDC says it has tracked the health of 2,500 people exposed to birds infected with H5N1 and only found one case of human infection, in Colorado.
A version of this article first appeared on WebMD.com.
A man who worked on a commercial poultry farm in Colorado has tested positive for avian influenza A(H5) virus, better known as H5 bird flu, the CDC announced on April 28.
This is the first case of H5 bird flu in humans in the United States and only the second case in the world, the CDC said in a news release. The first case was detected last December in a man who raised birds in the United Kingdom. That man had no symptoms.
The only symptom the man in Colorado reported was fatigue, the Colorado Department of Public Health and Environment (CDPHE) reported. He has recovered and is isolating and being treated with oseltamivir, an antiviral drug.
The CDC said the man was helping kill poultry that likely had the H5N1 bird flu.
He is a state prison inmate who was working on a commercial poultry farm in Montrose County in a prerelease employment program, the CDPHE said. The flock he was working with has been euthanized, and the response team and other inmates working on the farm were given protective equipment, the CDPHE said.
“Repeat testing on the person was negative for influenza,” the department said. “Because the person was in close contact with infected poultry, the virus may have been in the person’s nose without causing infection.”
This CDC said the case does not change the risk of bird flu for the general public, which is considered low. People who work with birds should continue to take safety precautions, such as wearing gloves when handling birds and avoiding birds that appear to be dead or ill, the CDC said.
“We want to reassure Coloradans that the risk to them is low,” said Rachel Herlihy, MD, state epidemiologist with the CDPHE. “I am grateful for the seamless collaboration between CDC, Department of Corrections, Department of Agriculture, and CDPHE, as we continue to monitor this virus and protect all Coloradans.”
The federal government says the H5N1 virus has been found in commercial and backyard birds in 29 states and in wild birds in 34 states since the first cases were detected in late 2021.
The CDC says it has tracked the health of 2,500 people exposed to birds infected with H5N1 and only found one case of human infection, in Colorado.
A version of this article first appeared on WebMD.com.
Upadacitinib earns FDA approval for ankylosing spondylitis
The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.
Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.
Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.
The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.
Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.
The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).
Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.
Read the complete prescribing information here.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.
Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.
Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.
The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.
Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.
The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).
Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.
Read the complete prescribing information here.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.
Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.
Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.
The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.
Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.
The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).
Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.
Read the complete prescribing information here.
A version of this article first appeared on Medscape.com.
FDA clears mavacamten (Camzyos) for obstructive hypertrophic cardiomyopathy
The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).
Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.
“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
‘Revolutionary’ change
The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.
In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.
The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.
Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.
“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.
The product information for mavacamten includes a boxed warning citing a risk for heart failure.
Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.
Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.
Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.
Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).
Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.
“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
‘Revolutionary’ change
The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.
In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.
The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.
Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.
“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.
The product information for mavacamten includes a boxed warning citing a risk for heart failure.
Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.
Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.
Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.
Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).
Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.
“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
‘Revolutionary’ change
The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.
In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.
The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.
Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.
“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.
The product information for mavacamten includes a boxed warning citing a risk for heart failure.
Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.
Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.
Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.
Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
FDA warns of pump defect with Medtronic HVAD system
Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals.
Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.
The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.
This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.
Pump thrombosis
Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.
All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.
Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.
The FDA does not recommend the elective removal of properly functioning systems.
“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.
Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.
If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.
For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.
The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.
Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals.
Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.
The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.
This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.
Pump thrombosis
Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.
All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.
Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.
The FDA does not recommend the elective removal of properly functioning systems.
“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.
Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.
If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.
For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.
The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.
Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals.
Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.
The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.
This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.
Pump thrombosis
Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.
All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.
Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.
The FDA does not recommend the elective removal of properly functioning systems.
“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.
Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.
If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.
For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.
The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.
Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
FDA approves oteseconazole for chronic yeast infections
The Food and Drug Administration has approved oteseconazole capsules (Vivjoa), an azole antifungal agent, for the prevention of recurrent yeast infections in women who are not of reproductive potential.
Oteseconazole inhibits CYP51, an enzyme fungi require to preserve the integrity of their cell walls and to grow properly, according to Mycovia, the drug’s manufacturer. It is the first FDA-approved product for the treatment of recurrent vulvovaginal candidiasis (RVVC).
Recurrent vulvovaginal candidiasis, or chronic yeast infection, affects an estimated 138 million women worldwide annually. The condition is defined as three or more symptomatic acute episodes of yeast infection within a 12-month period. The primary symptoms of RVVC include vaginal itching, burning, irritation, and inflammation. Some patients may also experience abnormal vaginal discharge and pain during sex or urination.
“A medicine with Vivjoa’s sustained efficacy combined with the clinical safety profile has been long needed, as until now, physicians and their patients have had no FDA-approved medications for RVVC,” Stephen Brand, PhD, chief development officer of Mycovia, said in a statement. “We are excited to be the first to offer a medication designed specifically for RVVC, a challenging and chronic condition that is expected to increase in prevalence over the next decade.”
Approval for oteseconazole was based on results of three phase 3 trials involving 875 patients at 232 sites across 11 countries. In the U.S.-only ultraVIOLET trial, 89.7% of women with RVVC who received oteseconazole cleared their initial yeast infection and did not experience a recurrence during the 50-week maintenance period, compared with 57.1% of those who received fluconazole (Diflucan) followed by placebo (P < .001), according to Mycovia.
The most common side effects reported in phase 3 clinical studies were headache (7.4%) and nausea (3.6%), the company said. Patients with a hypersensitivity to oteseconazole should not take the drug, nor should those who are of reproductive potential, pregnant, or lactating.
Mycovia said it plans to launch the drug in the second quarter of 2022.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved oteseconazole capsules (Vivjoa), an azole antifungal agent, for the prevention of recurrent yeast infections in women who are not of reproductive potential.
Oteseconazole inhibits CYP51, an enzyme fungi require to preserve the integrity of their cell walls and to grow properly, according to Mycovia, the drug’s manufacturer. It is the first FDA-approved product for the treatment of recurrent vulvovaginal candidiasis (RVVC).
Recurrent vulvovaginal candidiasis, or chronic yeast infection, affects an estimated 138 million women worldwide annually. The condition is defined as three or more symptomatic acute episodes of yeast infection within a 12-month period. The primary symptoms of RVVC include vaginal itching, burning, irritation, and inflammation. Some patients may also experience abnormal vaginal discharge and pain during sex or urination.
“A medicine with Vivjoa’s sustained efficacy combined with the clinical safety profile has been long needed, as until now, physicians and their patients have had no FDA-approved medications for RVVC,” Stephen Brand, PhD, chief development officer of Mycovia, said in a statement. “We are excited to be the first to offer a medication designed specifically for RVVC, a challenging and chronic condition that is expected to increase in prevalence over the next decade.”
Approval for oteseconazole was based on results of three phase 3 trials involving 875 patients at 232 sites across 11 countries. In the U.S.-only ultraVIOLET trial, 89.7% of women with RVVC who received oteseconazole cleared their initial yeast infection and did not experience a recurrence during the 50-week maintenance period, compared with 57.1% of those who received fluconazole (Diflucan) followed by placebo (P < .001), according to Mycovia.
The most common side effects reported in phase 3 clinical studies were headache (7.4%) and nausea (3.6%), the company said. Patients with a hypersensitivity to oteseconazole should not take the drug, nor should those who are of reproductive potential, pregnant, or lactating.
Mycovia said it plans to launch the drug in the second quarter of 2022.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved oteseconazole capsules (Vivjoa), an azole antifungal agent, for the prevention of recurrent yeast infections in women who are not of reproductive potential.
Oteseconazole inhibits CYP51, an enzyme fungi require to preserve the integrity of their cell walls and to grow properly, according to Mycovia, the drug’s manufacturer. It is the first FDA-approved product for the treatment of recurrent vulvovaginal candidiasis (RVVC).
Recurrent vulvovaginal candidiasis, or chronic yeast infection, affects an estimated 138 million women worldwide annually. The condition is defined as three or more symptomatic acute episodes of yeast infection within a 12-month period. The primary symptoms of RVVC include vaginal itching, burning, irritation, and inflammation. Some patients may also experience abnormal vaginal discharge and pain during sex or urination.
“A medicine with Vivjoa’s sustained efficacy combined with the clinical safety profile has been long needed, as until now, physicians and their patients have had no FDA-approved medications for RVVC,” Stephen Brand, PhD, chief development officer of Mycovia, said in a statement. “We are excited to be the first to offer a medication designed specifically for RVVC, a challenging and chronic condition that is expected to increase in prevalence over the next decade.”
Approval for oteseconazole was based on results of three phase 3 trials involving 875 patients at 232 sites across 11 countries. In the U.S.-only ultraVIOLET trial, 89.7% of women with RVVC who received oteseconazole cleared their initial yeast infection and did not experience a recurrence during the 50-week maintenance period, compared with 57.1% of those who received fluconazole (Diflucan) followed by placebo (P < .001), according to Mycovia.
The most common side effects reported in phase 3 clinical studies were headache (7.4%) and nausea (3.6%), the company said. Patients with a hypersensitivity to oteseconazole should not take the drug, nor should those who are of reproductive potential, pregnant, or lactating.
Mycovia said it plans to launch the drug in the second quarter of 2022.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
Prenatal DNA tests lead to false alarms, FDA warns
Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.
These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.
The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.
The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.
The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.
“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”
The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”
Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.
The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.
“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”
A version of this article first appeared on WebMD.com.
Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.
These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.
The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.
The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.
The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.
“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”
The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”
Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.
The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.
“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”
A version of this article first appeared on WebMD.com.
Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.
These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.
The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.
The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.
The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.
“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”
The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”
Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.
The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.
“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”
A version of this article first appeared on WebMD.com.
FDA warns companies selling OTC skin lighteners
The as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.
The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.
Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.
Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)
“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.
The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.
The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.
The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.
The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.
Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
The as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.
The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.
Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.
Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)
“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.
The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.
The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.
The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.
The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.
Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
The as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.
The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.
Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.
Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)
“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.
The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.
The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.
The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.
The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.
Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
FDA okays first sublingual med for agitation in serious mental illness
This is the first FDA-approved, orally dissolving, self-administered sublingual treatment for this indication. With a demonstrated onset of action as early as 20 minutes, it shows a high response rate in patients at both 120-mcg and 180-mcg doses.
An estimated 7.3 million individuals in the United States are diagnosed with schizophrenia or bipolar disorders, and up to one-quarter of them experience episodes of agitation that can occur 10-17 times annually. These episodes represent a significant burden for patients, caregivers, and the health care system.
“There are large numbers of patients who experience agitation associated with schizophrenia and bipolar disorders, and this condition has been a long-standing challenge for health care professionals to treat,” said John Krystal, MD, the Robert L. McNeil Jr. Professor of Translational Research and chair of the department of psychiatry at Yale University, New Haven, Conn.
“The approval of Igalmi, a self-administered film with a desirable onset of action, represents a milestone moment. It provides health care teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option,” he added.
“Igalmi is the first new acute treatment for schizophrenia or bipolar disorder–associated agitation in nearly a decade and represents a differentiated approach to helping patients manage this difficult and debilitating symptom,” said Vimal Mehta, PhD, CEO of BioXcel Therapeutics.
The FDA approval of Igalmi is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel-group, phase 3 trials that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).
The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension. All adverse drug reactions were mild to moderate in severity. While Igalmi was not associated with any treatment-related serious adverse effects in phase 3 studies, it may cause notable side effects, including hypotension, orthostatic hypotension, bradycardia, QT interval prolongation, and somnolence.
As previously reported by this news organization, data from the phase 3 SERENITY II trial that evaluated Igalmi in bipolar disorders were published in JAMA.
A version of this article first appeared on Medscape.com.
This is the first FDA-approved, orally dissolving, self-administered sublingual treatment for this indication. With a demonstrated onset of action as early as 20 minutes, it shows a high response rate in patients at both 120-mcg and 180-mcg doses.
An estimated 7.3 million individuals in the United States are diagnosed with schizophrenia or bipolar disorders, and up to one-quarter of them experience episodes of agitation that can occur 10-17 times annually. These episodes represent a significant burden for patients, caregivers, and the health care system.
“There are large numbers of patients who experience agitation associated with schizophrenia and bipolar disorders, and this condition has been a long-standing challenge for health care professionals to treat,” said John Krystal, MD, the Robert L. McNeil Jr. Professor of Translational Research and chair of the department of psychiatry at Yale University, New Haven, Conn.
“The approval of Igalmi, a self-administered film with a desirable onset of action, represents a milestone moment. It provides health care teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option,” he added.
“Igalmi is the first new acute treatment for schizophrenia or bipolar disorder–associated agitation in nearly a decade and represents a differentiated approach to helping patients manage this difficult and debilitating symptom,” said Vimal Mehta, PhD, CEO of BioXcel Therapeutics.
The FDA approval of Igalmi is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel-group, phase 3 trials that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).
The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension. All adverse drug reactions were mild to moderate in severity. While Igalmi was not associated with any treatment-related serious adverse effects in phase 3 studies, it may cause notable side effects, including hypotension, orthostatic hypotension, bradycardia, QT interval prolongation, and somnolence.
As previously reported by this news organization, data from the phase 3 SERENITY II trial that evaluated Igalmi in bipolar disorders were published in JAMA.
A version of this article first appeared on Medscape.com.
This is the first FDA-approved, orally dissolving, self-administered sublingual treatment for this indication. With a demonstrated onset of action as early as 20 minutes, it shows a high response rate in patients at both 120-mcg and 180-mcg doses.
An estimated 7.3 million individuals in the United States are diagnosed with schizophrenia or bipolar disorders, and up to one-quarter of them experience episodes of agitation that can occur 10-17 times annually. These episodes represent a significant burden for patients, caregivers, and the health care system.
“There are large numbers of patients who experience agitation associated with schizophrenia and bipolar disorders, and this condition has been a long-standing challenge for health care professionals to treat,” said John Krystal, MD, the Robert L. McNeil Jr. Professor of Translational Research and chair of the department of psychiatry at Yale University, New Haven, Conn.
“The approval of Igalmi, a self-administered film with a desirable onset of action, represents a milestone moment. It provides health care teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option,” he added.
“Igalmi is the first new acute treatment for schizophrenia or bipolar disorder–associated agitation in nearly a decade and represents a differentiated approach to helping patients manage this difficult and debilitating symptom,” said Vimal Mehta, PhD, CEO of BioXcel Therapeutics.
The FDA approval of Igalmi is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel-group, phase 3 trials that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).
The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension. All adverse drug reactions were mild to moderate in severity. While Igalmi was not associated with any treatment-related serious adverse effects in phase 3 studies, it may cause notable side effects, including hypotension, orthostatic hypotension, bradycardia, QT interval prolongation, and somnolence.
As previously reported by this news organization, data from the phase 3 SERENITY II trial that evaluated Igalmi in bipolar disorders were published in JAMA.
A version of this article first appeared on Medscape.com.
FDA: Switch to disposable duodenoscope models
Health care facilities and providers should complete the transition to fully disposable duodenoscopes and those with disposable components, the U.S. Food and Drug Administration announced this week after an analysis of postmarket surveillance studies was completed.
The FDA’s directive updates its April 2020 recommendations on the subject. It cites concerns about cleaning fixed endcap duodenoscopes and the increasing availability of models that eliminate the need for reprocessing.
The announcement highlighted the potential for a dramatic difference in between-patient contamination risk, reducing it “by half or more as compared to reusable, or fixed endcaps.”
“Interim results from one duodenoscope model with a removable component show a contamination rate of just 0.5%, as compared to older duodenoscope models which had contamination rates as high as 6%,” the FDA writes.
Duodenoscopes are used in more than 500,000 procedures each year in the United States and are key in assessing and treating diseases and conditions of the pancreas and bile ducts.
Upgrade to new models to decrease infections
Manufacturers no longer market fixed endcap models in the United States, but some health care facilities continue to use them. The FDA recommends that all fixed endcap models be replaced.
The FDA says some manufacturers are offering replacement programs to upgrade to a model with a disposable component at no cost.
Two fully disposable models and five with disposable components have been cleared by the FDA. (One model is no longer marketed and thus not listed here.)
Fully Disposable:
Ambu Innovation GmbH, Duodenoscope model aScope Duodeno
Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope
Disposable Components:
Fujifilm Corporation, Duodenoscope model ED-580XT
Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Pentax Medical, Duodenoscope model ED34-i10T2
Pentax Medical, Duodenoscope model ED32-i10
Additionally, the failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient transferring to a subsequent patient.
“In rare cases, this can lead to patient-to-patient disease transmission,” the FDA says.
Postmarket surveillance studies
In 2015, the FDA ordered three manufacturers of reusable devices (Fujifilm, Olympus, and Pentax) to conduct postmarket surveillance studies to determine contamination rates after reprocessing.
In 2019, the FDA also ordered postmarket surveillance studies to the makers of duodenoscopes with disposable endcaps to verify that the new designs reduce the contamination rate.
The final results of the fixed endcap design indicate that contamination rates were as high as 6.6% with high-concern organisms after contamination. High-concern organisms are those more often associated with disease, such as E coli and Pseudomonas contamination.
“As a result, Pentax and Olympus are withdrawing their fixed endcap duodenoscopes from the market, and Fujifilm has completed withdrawal of its fixed endcap duodenoscope,” the FDA writes.
Studies are not yet complete for duodenoscopes with removable components. As of August 12, 2021, the Fujifilm ED-580XT duodenoscope with a removable cap had 57% of the samples required. Interim results indicate that no samples tested positive for enough low-concern organisms to indicate a reprocessing failure, and only 0.5% tested positive for high-concern organisms.
In addition to the contamination risk sampling, each manufacturer was ordered to do postmarket surveillance studies to evaluate whether staff could understand and follow the manufacturer’s reprocessing instructions in real-world health care settings.
According to the FDA, the results showed that users frequently had difficulty understanding and following the manufacturers’ instructions and were not able to successfully complete reprocessing with the older models.
However, the newer models had high user success rates for understanding instructions and correctly performing reprocessing tasks, the FDA says.
A version of this article first appeared on Medscape.com.
Health care facilities and providers should complete the transition to fully disposable duodenoscopes and those with disposable components, the U.S. Food and Drug Administration announced this week after an analysis of postmarket surveillance studies was completed.
The FDA’s directive updates its April 2020 recommendations on the subject. It cites concerns about cleaning fixed endcap duodenoscopes and the increasing availability of models that eliminate the need for reprocessing.
The announcement highlighted the potential for a dramatic difference in between-patient contamination risk, reducing it “by half or more as compared to reusable, or fixed endcaps.”
“Interim results from one duodenoscope model with a removable component show a contamination rate of just 0.5%, as compared to older duodenoscope models which had contamination rates as high as 6%,” the FDA writes.
Duodenoscopes are used in more than 500,000 procedures each year in the United States and are key in assessing and treating diseases and conditions of the pancreas and bile ducts.
Upgrade to new models to decrease infections
Manufacturers no longer market fixed endcap models in the United States, but some health care facilities continue to use them. The FDA recommends that all fixed endcap models be replaced.
The FDA says some manufacturers are offering replacement programs to upgrade to a model with a disposable component at no cost.
Two fully disposable models and five with disposable components have been cleared by the FDA. (One model is no longer marketed and thus not listed here.)
Fully Disposable:
Ambu Innovation GmbH, Duodenoscope model aScope Duodeno
Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope
Disposable Components:
Fujifilm Corporation, Duodenoscope model ED-580XT
Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Pentax Medical, Duodenoscope model ED34-i10T2
Pentax Medical, Duodenoscope model ED32-i10
Additionally, the failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient transferring to a subsequent patient.
“In rare cases, this can lead to patient-to-patient disease transmission,” the FDA says.
Postmarket surveillance studies
In 2015, the FDA ordered three manufacturers of reusable devices (Fujifilm, Olympus, and Pentax) to conduct postmarket surveillance studies to determine contamination rates after reprocessing.
In 2019, the FDA also ordered postmarket surveillance studies to the makers of duodenoscopes with disposable endcaps to verify that the new designs reduce the contamination rate.
The final results of the fixed endcap design indicate that contamination rates were as high as 6.6% with high-concern organisms after contamination. High-concern organisms are those more often associated with disease, such as E coli and Pseudomonas contamination.
“As a result, Pentax and Olympus are withdrawing their fixed endcap duodenoscopes from the market, and Fujifilm has completed withdrawal of its fixed endcap duodenoscope,” the FDA writes.
Studies are not yet complete for duodenoscopes with removable components. As of August 12, 2021, the Fujifilm ED-580XT duodenoscope with a removable cap had 57% of the samples required. Interim results indicate that no samples tested positive for enough low-concern organisms to indicate a reprocessing failure, and only 0.5% tested positive for high-concern organisms.
In addition to the contamination risk sampling, each manufacturer was ordered to do postmarket surveillance studies to evaluate whether staff could understand and follow the manufacturer’s reprocessing instructions in real-world health care settings.
According to the FDA, the results showed that users frequently had difficulty understanding and following the manufacturers’ instructions and were not able to successfully complete reprocessing with the older models.
However, the newer models had high user success rates for understanding instructions and correctly performing reprocessing tasks, the FDA says.
A version of this article first appeared on Medscape.com.
Health care facilities and providers should complete the transition to fully disposable duodenoscopes and those with disposable components, the U.S. Food and Drug Administration announced this week after an analysis of postmarket surveillance studies was completed.
The FDA’s directive updates its April 2020 recommendations on the subject. It cites concerns about cleaning fixed endcap duodenoscopes and the increasing availability of models that eliminate the need for reprocessing.
The announcement highlighted the potential for a dramatic difference in between-patient contamination risk, reducing it “by half or more as compared to reusable, or fixed endcaps.”
“Interim results from one duodenoscope model with a removable component show a contamination rate of just 0.5%, as compared to older duodenoscope models which had contamination rates as high as 6%,” the FDA writes.
Duodenoscopes are used in more than 500,000 procedures each year in the United States and are key in assessing and treating diseases and conditions of the pancreas and bile ducts.
Upgrade to new models to decrease infections
Manufacturers no longer market fixed endcap models in the United States, but some health care facilities continue to use them. The FDA recommends that all fixed endcap models be replaced.
The FDA says some manufacturers are offering replacement programs to upgrade to a model with a disposable component at no cost.
Two fully disposable models and five with disposable components have been cleared by the FDA. (One model is no longer marketed and thus not listed here.)
Fully Disposable:
Ambu Innovation GmbH, Duodenoscope model aScope Duodeno
Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope
Disposable Components:
Fujifilm Corporation, Duodenoscope model ED-580XT
Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Pentax Medical, Duodenoscope model ED34-i10T2
Pentax Medical, Duodenoscope model ED32-i10
Additionally, the failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient transferring to a subsequent patient.
“In rare cases, this can lead to patient-to-patient disease transmission,” the FDA says.
Postmarket surveillance studies
In 2015, the FDA ordered three manufacturers of reusable devices (Fujifilm, Olympus, and Pentax) to conduct postmarket surveillance studies to determine contamination rates after reprocessing.
In 2019, the FDA also ordered postmarket surveillance studies to the makers of duodenoscopes with disposable endcaps to verify that the new designs reduce the contamination rate.
The final results of the fixed endcap design indicate that contamination rates were as high as 6.6% with high-concern organisms after contamination. High-concern organisms are those more often associated with disease, such as E coli and Pseudomonas contamination.
“As a result, Pentax and Olympus are withdrawing their fixed endcap duodenoscopes from the market, and Fujifilm has completed withdrawal of its fixed endcap duodenoscope,” the FDA writes.
Studies are not yet complete for duodenoscopes with removable components. As of August 12, 2021, the Fujifilm ED-580XT duodenoscope with a removable cap had 57% of the samples required. Interim results indicate that no samples tested positive for enough low-concern organisms to indicate a reprocessing failure, and only 0.5% tested positive for high-concern organisms.
In addition to the contamination risk sampling, each manufacturer was ordered to do postmarket surveillance studies to evaluate whether staff could understand and follow the manufacturer’s reprocessing instructions in real-world health care settings.
According to the FDA, the results showed that users frequently had difficulty understanding and following the manufacturers’ instructions and were not able to successfully complete reprocessing with the older models.
However, the newer models had high user success rates for understanding instructions and correctly performing reprocessing tasks, the FDA says.
A version of this article first appeared on Medscape.com.
FDA approves leadless, single-chamber pacemaker system
The Food and Drug Administration has granted approval to Abbott’s Aveir leadless, single-chamber pacemaker system for patients with bradycardia.
In a press release, Abbott said the device has a unique mapping capability that allows interventionists implanting the device to measure electrical signals within the heart to determine the correct placement before final implantation. Aveir is implanted directly into the right ventricle via a catheter.
The company also said Aveir has a battery life that’s up to twice as long as other commercially available leadless pacemakers when following International Association for Standardization (ISO) standard settings. And the device can be retrieved if necessary, the press release said.
“Leadless pacemakers address known complications associated with traditional pacemakers,” Rahul Doshi, MD, director of electrophysiology at Honor Health in Scottsdale, Ariz., said in the press release. “In addition, the Aveir leadless pacemaker brings unique innovations we’ve been seeking, such as the ability to ensure electrical performance before we commit to placement.”
Investigators of the LEADLESS II phase 2 study reported last year on what they called “key design improvements” of the Aveir device compared to the first leadless pacemaker, the discontinued Nanostim. They included a 12% longer battery life, a shorter and wider form factor, a modified docking button that allows for retrievability, a modified delivery system, and an application-specific integrated circuit chip that can support a dual-chamber pacing system in the future.
The study reported that 96% of the 200 enrolled patients met the primary safety endpoint of no serious device-related adverse events at 6 weeks after implantation. A similar percentage achieved therapeutic pacing and sensing amplitude.
The study also reported that interventionists accurately positioned Aveir the first time or with a single repositioning in 96% of cases.
The Food and Drug Administration has granted approval to Abbott’s Aveir leadless, single-chamber pacemaker system for patients with bradycardia.
In a press release, Abbott said the device has a unique mapping capability that allows interventionists implanting the device to measure electrical signals within the heart to determine the correct placement before final implantation. Aveir is implanted directly into the right ventricle via a catheter.
The company also said Aveir has a battery life that’s up to twice as long as other commercially available leadless pacemakers when following International Association for Standardization (ISO) standard settings. And the device can be retrieved if necessary, the press release said.
“Leadless pacemakers address known complications associated with traditional pacemakers,” Rahul Doshi, MD, director of electrophysiology at Honor Health in Scottsdale, Ariz., said in the press release. “In addition, the Aveir leadless pacemaker brings unique innovations we’ve been seeking, such as the ability to ensure electrical performance before we commit to placement.”
Investigators of the LEADLESS II phase 2 study reported last year on what they called “key design improvements” of the Aveir device compared to the first leadless pacemaker, the discontinued Nanostim. They included a 12% longer battery life, a shorter and wider form factor, a modified docking button that allows for retrievability, a modified delivery system, and an application-specific integrated circuit chip that can support a dual-chamber pacing system in the future.
The study reported that 96% of the 200 enrolled patients met the primary safety endpoint of no serious device-related adverse events at 6 weeks after implantation. A similar percentage achieved therapeutic pacing and sensing amplitude.
The study also reported that interventionists accurately positioned Aveir the first time or with a single repositioning in 96% of cases.
The Food and Drug Administration has granted approval to Abbott’s Aveir leadless, single-chamber pacemaker system for patients with bradycardia.
In a press release, Abbott said the device has a unique mapping capability that allows interventionists implanting the device to measure electrical signals within the heart to determine the correct placement before final implantation. Aveir is implanted directly into the right ventricle via a catheter.
The company also said Aveir has a battery life that’s up to twice as long as other commercially available leadless pacemakers when following International Association for Standardization (ISO) standard settings. And the device can be retrieved if necessary, the press release said.
“Leadless pacemakers address known complications associated with traditional pacemakers,” Rahul Doshi, MD, director of electrophysiology at Honor Health in Scottsdale, Ariz., said in the press release. “In addition, the Aveir leadless pacemaker brings unique innovations we’ve been seeking, such as the ability to ensure electrical performance before we commit to placement.”
Investigators of the LEADLESS II phase 2 study reported last year on what they called “key design improvements” of the Aveir device compared to the first leadless pacemaker, the discontinued Nanostim. They included a 12% longer battery life, a shorter and wider form factor, a modified docking button that allows for retrievability, a modified delivery system, and an application-specific integrated circuit chip that can support a dual-chamber pacing system in the future.
The study reported that 96% of the 200 enrolled patients met the primary safety endpoint of no serious device-related adverse events at 6 weeks after implantation. A similar percentage achieved therapeutic pacing and sensing amplitude.
The study also reported that interventionists accurately positioned Aveir the first time or with a single repositioning in 96% of cases.