Abigail Cruz

The Communication and Optimal Resolution tool kit, offered by the Agency for Healthcare Research and Quality, helps hospitals, health systems, and clinicians respond to patients who are harmed by the care they receive, Andy Bindman, MD, AHRQ director, said in a blog post.

The tool kit is a new addition to AHRQ’s suite of patient safety tools and training materials.

Poor communication can lead to life-and-death mistakes, which can then become legal issues, said Dr. Bindman. The Communication and Optimal Resolution (CANDOR) tool kit uses time as a key factor by disclosing harm to patients and families as soon as it happens.

“It has been estimated that medical errors are the third-leading cause of death in the United States and that the majority of clinicians have experience with a medical error that resulted in harm to a patient. Often these ‘mistakes’ are not the result of poorly trained individuals but the result of the faulty systems we sometimes work in,” Dr. Bindman noted.

“It is also important for us to engage with colleagues to reflect on the mistake and explore the root causes of how it happened. This helps us to learn from the situation and take steps to minimize the chances of a similar mistake happening again to another patient,” he said.

Funding for CANDOR was provided by the AHRQ’s $23 million Patient Safety and Medical Liability grant initiative, launched in 2009. The initiative is the largest federal investment in research linking improved patient safety to reduced medical liability, according to Dr. Bindman.

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The Communication and Optimal Resolution tool kit, offered by the Agency for Healthcare Research and Quality, helps hospitals, health systems, and clinicians respond to patients who are harmed by the care they receive, Andy Bindman, MD, AHRQ director, said in a blog post.

The tool kit is a new addition to AHRQ’s suite of patient safety tools and training materials.

Poor communication can lead to life-and-death mistakes, which can then become legal issues, said Dr. Bindman. The Communication and Optimal Resolution (CANDOR) tool kit uses time as a key factor by disclosing harm to patients and families as soon as it happens.

“It has been estimated that medical errors are the third-leading cause of death in the United States and that the majority of clinicians have experience with a medical error that resulted in harm to a patient. Often these ‘mistakes’ are not the result of poorly trained individuals but the result of the faulty systems we sometimes work in,” Dr. Bindman noted.

“It is also important for us to engage with colleagues to reflect on the mistake and explore the root causes of how it happened. This helps us to learn from the situation and take steps to minimize the chances of a similar mistake happening again to another patient,” he said.

Funding for CANDOR was provided by the AHRQ’s $23 million Patient Safety and Medical Liability grant initiative, launched in 2009. The initiative is the largest federal investment in research linking improved patient safety to reduced medical liability, according to Dr. Bindman.

[email protected]

The Communication and Optimal Resolution tool kit, offered by the Agency for Healthcare Research and Quality, helps hospitals, health systems, and clinicians respond to patients who are harmed by the care they receive, Andy Bindman, MD, AHRQ director, said in a blog post.

The tool kit is a new addition to AHRQ’s suite of patient safety tools and training materials.

Poor communication can lead to life-and-death mistakes, which can then become legal issues, said Dr. Bindman. The Communication and Optimal Resolution (CANDOR) tool kit uses time as a key factor by disclosing harm to patients and families as soon as it happens.

“It has been estimated that medical errors are the third-leading cause of death in the United States and that the majority of clinicians have experience with a medical error that resulted in harm to a patient. Often these ‘mistakes’ are not the result of poorly trained individuals but the result of the faulty systems we sometimes work in,” Dr. Bindman noted.

“It is also important for us to engage with colleagues to reflect on the mistake and explore the root causes of how it happened. This helps us to learn from the situation and take steps to minimize the chances of a similar mistake happening again to another patient,” he said.

Funding for CANDOR was provided by the AHRQ’s $23 million Patient Safety and Medical Liability grant initiative, launched in 2009. The initiative is the largest federal investment in research linking improved patient safety to reduced medical liability, according to Dr. Bindman.

[email protected]

Adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis can now be prescribed Epclusa. The Food and Drug Administration approved the fixed-dose combination tablet is the first treatment that controls genotypes 1-6 of HCV.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Epclusa, which contains sofosbuvir and velpatasvir, is manufactured by Gilead Sciences, located in Foster City, Calif. Before approval, the drug was evaluated for 12 weeks in three phase III clinical trials that included 1,558 patients diagnosed without cirrhosis and patients with compensated cirrhosis. Twelve weeks after finishing treatment, 95%-99% of patients who received Epclusa had no signs of infection. Epclusa cured the condition, which means no sign of the virus was detected in any of the patients’ blood. In addition, 267 patients were studied for the safety and efficacy of Epclusa, 87 of whom took Epclusa in combination with ribavirin for 12 weeks, and 94% of these patients had no virus detected in the blood 12 weeks after finishing treatment.

Side effects of Epclusa include headache and fatigue. Epclusa also carries a warning not to use with certain drugs that may reduce the effective amount of Epclusa.

[email protected]

Adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis can now be prescribed Epclusa. The Food and Drug Administration approved the fixed-dose combination tablet is the first treatment that controls genotypes 1-6 of HCV.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Epclusa, which contains sofosbuvir and velpatasvir, is manufactured by Gilead Sciences, located in Foster City, Calif. Before approval, the drug was evaluated for 12 weeks in three phase III clinical trials that included 1,558 patients diagnosed without cirrhosis and patients with compensated cirrhosis. Twelve weeks after finishing treatment, 95%-99% of patients who received Epclusa had no signs of infection. Epclusa cured the condition, which means no sign of the virus was detected in any of the patients’ blood. In addition, 267 patients were studied for the safety and efficacy of Epclusa, 87 of whom took Epclusa in combination with ribavirin for 12 weeks, and 94% of these patients had no virus detected in the blood 12 weeks after finishing treatment.

Side effects of Epclusa include headache and fatigue. Epclusa also carries a warning not to use with certain drugs that may reduce the effective amount of Epclusa.

[email protected]

Adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis can now be prescribed Epclusa. The Food and Drug Administration approved the fixed-dose combination tablet is the first treatment that controls genotypes 1-6 of HCV.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Epclusa, which contains sofosbuvir and velpatasvir, is manufactured by Gilead Sciences, located in Foster City, Calif. Before approval, the drug was evaluated for 12 weeks in three phase III clinical trials that included 1,558 patients diagnosed without cirrhosis and patients with compensated cirrhosis. Twelve weeks after finishing treatment, 95%-99% of patients who received Epclusa had no signs of infection. Epclusa cured the condition, which means no sign of the virus was detected in any of the patients’ blood. In addition, 267 patients were studied for the safety and efficacy of Epclusa, 87 of whom took Epclusa in combination with ribavirin for 12 weeks, and 94% of these patients had no virus detected in the blood 12 weeks after finishing treatment.

Side effects of Epclusa include headache and fatigue. Epclusa also carries a warning not to use with certain drugs that may reduce the effective amount of Epclusa.

[email protected]

Using escitalopram for patients with chronic heart failure and depression for more than 18 months neither significantly reduces mortality or hospitalization, nor improves depression, a study published June 28 involving 372 patients shows.

“To our knowledge, this study was the first to investigate the composite all-cause mortality and hospitalization in a population with heart failure treated with escitalopram,” wrote Dr. Christiane E. Angermann and her associates.

They said the only other randomized trial evaluating selective serotonin reuptake inhibitors in patients with heart failure was the Sertraline Against Depression and Heart Disease in Chronic Heart Failure study, which found that sertraline did not improve depression or cardiovascular status. But the treatment duration in that study was only 12 weeks, reported Dr. Angermann of the Cardiology and Comprehensive Heart Failure Center, Würzburg, Germany.

The current study, called the Effects of Selective Serotonin Re-Uptake Inhibition on Morbidity, Mortality, and Mood in Depressed Heart Failure Patients, was a double-blind, placebo-controlled randomized trial conducted at 16 tertiary medical centers in Germany. Three hundred seventy-two patients (185 in the escitalopram group and 187 in the placebo group) were randomized and given at least one dose of the study medication. The study was supposed to last for 24 months, but the investigators stopped it early.

Primary outcome of death or hospitalization occurred in 116 (63%) patients and 119 (64%) patients, respectively (hazard ratio, 0.99; 95% confidence interval, 0.76-1.27; P = .92).

Read more of the study and findings on the JAMA website (doi: 10.1001/jama.2016.7635).

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Using escitalopram for patients with chronic heart failure and depression for more than 18 months neither significantly reduces mortality or hospitalization, nor improves depression, a study published June 28 involving 372 patients shows.

“To our knowledge, this study was the first to investigate the composite all-cause mortality and hospitalization in a population with heart failure treated with escitalopram,” wrote Dr. Christiane E. Angermann and her associates.

They said the only other randomized trial evaluating selective serotonin reuptake inhibitors in patients with heart failure was the Sertraline Against Depression and Heart Disease in Chronic Heart Failure study, which found that sertraline did not improve depression or cardiovascular status. But the treatment duration in that study was only 12 weeks, reported Dr. Angermann of the Cardiology and Comprehensive Heart Failure Center, Würzburg, Germany.

The current study, called the Effects of Selective Serotonin Re-Uptake Inhibition on Morbidity, Mortality, and Mood in Depressed Heart Failure Patients, was a double-blind, placebo-controlled randomized trial conducted at 16 tertiary medical centers in Germany. Three hundred seventy-two patients (185 in the escitalopram group and 187 in the placebo group) were randomized and given at least one dose of the study medication. The study was supposed to last for 24 months, but the investigators stopped it early.

Primary outcome of death or hospitalization occurred in 116 (63%) patients and 119 (64%) patients, respectively (hazard ratio, 0.99; 95% confidence interval, 0.76-1.27; P = .92).

Read more of the study and findings on the JAMA website (doi: 10.1001/jama.2016.7635).

[email protected]

Using escitalopram for patients with chronic heart failure and depression for more than 18 months neither significantly reduces mortality or hospitalization, nor improves depression, a study published June 28 involving 372 patients shows.

“To our knowledge, this study was the first to investigate the composite all-cause mortality and hospitalization in a population with heart failure treated with escitalopram,” wrote Dr. Christiane E. Angermann and her associates.

They said the only other randomized trial evaluating selective serotonin reuptake inhibitors in patients with heart failure was the Sertraline Against Depression and Heart Disease in Chronic Heart Failure study, which found that sertraline did not improve depression or cardiovascular status. But the treatment duration in that study was only 12 weeks, reported Dr. Angermann of the Cardiology and Comprehensive Heart Failure Center, Würzburg, Germany.

The current study, called the Effects of Selective Serotonin Re-Uptake Inhibition on Morbidity, Mortality, and Mood in Depressed Heart Failure Patients, was a double-blind, placebo-controlled randomized trial conducted at 16 tertiary medical centers in Germany. Three hundred seventy-two patients (185 in the escitalopram group and 187 in the placebo group) were randomized and given at least one dose of the study medication. The study was supposed to last for 24 months, but the investigators stopped it early.

Primary outcome of death or hospitalization occurred in 116 (63%) patients and 119 (64%) patients, respectively (hazard ratio, 0.99; 95% confidence interval, 0.76-1.27; P = .92).

Read more of the study and findings on the JAMA website (doi: 10.1001/jama.2016.7635).

[email protected]

Between 1.1 million and 1.9 million sports- and recreation-related concussions (SRRCs) occur annually in U.S. children aged 18 years and under, according to a new study.

In the United States, more than 44 million children participate in sports annually, yet the number of SRRCs is unknown. “One challenge in calculating the incidence of SRRCs is that injured youth may not receive treatment, or may receive care from a variety of providers including certified athletic trainers, primary care, and emergency medicine physicians,” said Dr. Mersine A. Bryan of the University of Washington, Seattle, and her associates.

©s-c-s/Thinkstock

Three national databases were used in this study to conduct research for 2013. “Incidence rates were calculated on the basis of the number of claims divided by the number of enrollees,” they said.

Of children with SRRCs seen in health care settings, outpatient treatment had the highest number at 377,978 visits. The emergency department received between 115,479 and 166,929 sports-related visits, and there were 2,886-4,936 actual hospitalizations. Athletic trainer visits for all school sports totaled 85,885. The number of SRRCs not seen by any health care provider was estimated at 511,590-1,240,972.

The Centers for Disease Control and Prevention is currently developing a surveillance system for SRRCs that would include recreational sources of concussion.

Find the full study at the Journal of Pediatrics (2016 Jun 20. doi: 10.1542/peds.2015-4635).

[email protected]

Between 1.1 million and 1.9 million sports- and recreation-related concussions (SRRCs) occur annually in U.S. children aged 18 years and under, according to a new study.

In the United States, more than 44 million children participate in sports annually, yet the number of SRRCs is unknown. “One challenge in calculating the incidence of SRRCs is that injured youth may not receive treatment, or may receive care from a variety of providers including certified athletic trainers, primary care, and emergency medicine physicians,” said Dr. Mersine A. Bryan of the University of Washington, Seattle, and her associates.

©s-c-s/Thinkstock

Three national databases were used in this study to conduct research for 2013. “Incidence rates were calculated on the basis of the number of claims divided by the number of enrollees,” they said.

Of children with SRRCs seen in health care settings, outpatient treatment had the highest number at 377,978 visits. The emergency department received between 115,479 and 166,929 sports-related visits, and there were 2,886-4,936 actual hospitalizations. Athletic trainer visits for all school sports totaled 85,885. The number of SRRCs not seen by any health care provider was estimated at 511,590-1,240,972.

The Centers for Disease Control and Prevention is currently developing a surveillance system for SRRCs that would include recreational sources of concussion.

Find the full study at the Journal of Pediatrics (2016 Jun 20. doi: 10.1542/peds.2015-4635).

[email protected]

Between 1.1 million and 1.9 million sports- and recreation-related concussions (SRRCs) occur annually in U.S. children aged 18 years and under, according to a new study.

In the United States, more than 44 million children participate in sports annually, yet the number of SRRCs is unknown. “One challenge in calculating the incidence of SRRCs is that injured youth may not receive treatment, or may receive care from a variety of providers including certified athletic trainers, primary care, and emergency medicine physicians,” said Dr. Mersine A. Bryan of the University of Washington, Seattle, and her associates.

©s-c-s/Thinkstock

Three national databases were used in this study to conduct research for 2013. “Incidence rates were calculated on the basis of the number of claims divided by the number of enrollees,” they said.

Of children with SRRCs seen in health care settings, outpatient treatment had the highest number at 377,978 visits. The emergency department received between 115,479 and 166,929 sports-related visits, and there were 2,886-4,936 actual hospitalizations. Athletic trainer visits for all school sports totaled 85,885. The number of SRRCs not seen by any health care provider was estimated at 511,590-1,240,972.

The Centers for Disease Control and Prevention is currently developing a surveillance system for SRRCs that would include recreational sources of concussion.

Find the full study at the Journal of Pediatrics (2016 Jun 20. doi: 10.1542/peds.2015-4635).

[email protected]

The Food and Drug Administration has revised warnings on certain medications for type 2 diabetes mellitus based on recent reports of kidney injury. The warning labels on canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) now include recommendations on ways to minimize the risk and more information on kidney injury.

“From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use,” the FDA statement said.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA went on to note: “Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs). Assess kidney function prior to starting canagliflozin or dapagliflozin and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.”

The Food and Drug Administration has revised warnings on certain medications for type 2 diabetes mellitus based on recent reports of kidney injury. The warning labels on canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) now include recommendations on ways to minimize the risk and more information on kidney injury.

“From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use,” the FDA statement said.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA went on to note: “Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs). Assess kidney function prior to starting canagliflozin or dapagliflozin and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.”

The Food and Drug Administration has revised warnings on certain medications for type 2 diabetes mellitus based on recent reports of kidney injury. The warning labels on canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) now include recommendations on ways to minimize the risk and more information on kidney injury.

“From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use,” the FDA statement said.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA went on to note: “Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs). Assess kidney function prior to starting canagliflozin or dapagliflozin and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.”

The Food and Drug Administration has revised warnings on certain medications for type 2 diabetes mellitus based on recent reports of kidney injury. The warning labels on canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) now include recommendations on ways to minimize the risk and more information on kidney injury.

“From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use,” the FDA statement said.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA went on to note: “Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs). Assess kidney function prior to starting canagliflozin or dapagliflozin and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.”

[email protected]

The Food and Drug Administration has revised warnings on certain medications for type 2 diabetes mellitus based on recent reports of kidney injury. The warning labels on canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) now include recommendations on ways to minimize the risk and more information on kidney injury.

“From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use,” the FDA statement said.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA went on to note: “Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs). Assess kidney function prior to starting canagliflozin or dapagliflozin and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.”

[email protected]

The Food and Drug Administration has revised warnings on certain medications for type 2 diabetes mellitus based on recent reports of kidney injury. The warning labels on canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) now include recommendations on ways to minimize the risk and more information on kidney injury.

“From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use,” the FDA statement said.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA went on to note: “Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs). Assess kidney function prior to starting canagliflozin or dapagliflozin and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.”

[email protected]

Daclizumab (Zinbryta) has been approved as a patient-injected, once-monthly treatment for adults with relapsing forms of multiple sclerosis (MS), according to the Food and Drug Administration.

Daclizumab has serious safety risks, including severe and potentially life-threatening liver injury and immune disorders, and should generally be used only when patients have an inadequate response to two or more MS drugs, the FDA said in a press release. The drug has a boxed warning and is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.

Liver function tests should be performed before starting daclizumab, and liver function should be monitored monthly before each dose, and for up to 6 months after the last dose. Immune disorders associated with use of daclizumab include noninfectious colitis, skin reactions, and lymphadenopathy. Other highlighted warnings include anaphylaxis and angioedema, increased risk of infections, and symptoms of depression and suicidal ideation.

Daclizumab was associated with a reduction in clinical relapses in a comparator trial of 1,841 participants who received either daclizumab or interferon beta-1a (Avonex) and were studied for 144 weeks. Fewer relapses also were seen with daclizumab than with placebo in a second 52-week study of 412 participants.

The most common adverse reactions reported by patients receiving daclizumab in the comparator trial included nasopharyngitis, upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal pain, eczema, and enlargement of lymph nodes. The most common adverse reactions reported in the placebo trial were depression, rash, and increased levels of alanine aminotransferase.

Daclizumab will be marketed as Zinbryta by Biogen.

Read the FDA’s full statement on the FDA website.

[email protected]

Daclizumab (Zinbryta) has been approved as a patient-injected, once-monthly treatment for adults with relapsing forms of multiple sclerosis (MS), according to the Food and Drug Administration.

Daclizumab has serious safety risks, including severe and potentially life-threatening liver injury and immune disorders, and should generally be used only when patients have an inadequate response to two or more MS drugs, the FDA said in a press release. The drug has a boxed warning and is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.

Liver function tests should be performed before starting daclizumab, and liver function should be monitored monthly before each dose, and for up to 6 months after the last dose. Immune disorders associated with use of daclizumab include noninfectious colitis, skin reactions, and lymphadenopathy. Other highlighted warnings include anaphylaxis and angioedema, increased risk of infections, and symptoms of depression and suicidal ideation.

Daclizumab was associated with a reduction in clinical relapses in a comparator trial of 1,841 participants who received either daclizumab or interferon beta-1a (Avonex) and were studied for 144 weeks. Fewer relapses also were seen with daclizumab than with placebo in a second 52-week study of 412 participants.

The most common adverse reactions reported by patients receiving daclizumab in the comparator trial included nasopharyngitis, upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal pain, eczema, and enlargement of lymph nodes. The most common adverse reactions reported in the placebo trial were depression, rash, and increased levels of alanine aminotransferase.

Daclizumab will be marketed as Zinbryta by Biogen.

Read the FDA’s full statement on the FDA website.

[email protected]

Daclizumab (Zinbryta) has been approved as a patient-injected, once-monthly treatment for adults with relapsing forms of multiple sclerosis (MS), according to the Food and Drug Administration.

Daclizumab has serious safety risks, including severe and potentially life-threatening liver injury and immune disorders, and should generally be used only when patients have an inadequate response to two or more MS drugs, the FDA said in a press release. The drug has a boxed warning and is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.

Liver function tests should be performed before starting daclizumab, and liver function should be monitored monthly before each dose, and for up to 6 months after the last dose. Immune disorders associated with use of daclizumab include noninfectious colitis, skin reactions, and lymphadenopathy. Other highlighted warnings include anaphylaxis and angioedema, increased risk of infections, and symptoms of depression and suicidal ideation.

Daclizumab was associated with a reduction in clinical relapses in a comparator trial of 1,841 participants who received either daclizumab or interferon beta-1a (Avonex) and were studied for 144 weeks. Fewer relapses also were seen with daclizumab than with placebo in a second 52-week study of 412 participants.

The most common adverse reactions reported by patients receiving daclizumab in the comparator trial included nasopharyngitis, upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal pain, eczema, and enlargement of lymph nodes. The most common adverse reactions reported in the placebo trial were depression, rash, and increased levels of alanine aminotransferase.

Daclizumab will be marketed as Zinbryta by Biogen.

Read the FDA’s full statement on the FDA website.

[email protected]

Materials to support the families of children with serious illnesses have been developed by the National Institute of Nursing Research, which is part of the National Institutes of Health. The materials are associated with the NINR’s “Palliative Care: Conversations Matter” campaign.

“Palliative care is often associated with end of life, making it difficult for patients and their families – and even for healthcare providers – to start conversations around the subject. However, palliative care can be incredibly helpful for patients and their families at any stage during an illness. We hope these materials will improve patient and family understanding of pediatric palliative care and facilitate discussion with healthcare teams,” NINR Director Patricia A. Grady said in a written statement.

The resources, which include a fact sheet, a resource card to help families find support, and a series of family stories, are available in both Spanish and English. The NINR developed these materials with feedback from parents of seriously ill children. To learn more, click here

[email protected]

Materials to support the families of children with serious illnesses have been developed by the National Institute of Nursing Research, which is part of the National Institutes of Health. The materials are associated with the NINR’s “Palliative Care: Conversations Matter” campaign.

“Palliative care is often associated with end of life, making it difficult for patients and their families – and even for healthcare providers – to start conversations around the subject. However, palliative care can be incredibly helpful for patients and their families at any stage during an illness. We hope these materials will improve patient and family understanding of pediatric palliative care and facilitate discussion with healthcare teams,” NINR Director Patricia A. Grady said in a written statement.

The resources, which include a fact sheet, a resource card to help families find support, and a series of family stories, are available in both Spanish and English. The NINR developed these materials with feedback from parents of seriously ill children. To learn more, click here

[email protected]

Materials to support the families of children with serious illnesses have been developed by the National Institute of Nursing Research, which is part of the National Institutes of Health. The materials are associated with the NINR’s “Palliative Care: Conversations Matter” campaign.

“Palliative care is often associated with end of life, making it difficult for patients and their families – and even for healthcare providers – to start conversations around the subject. However, palliative care can be incredibly helpful for patients and their families at any stage during an illness. We hope these materials will improve patient and family understanding of pediatric palliative care and facilitate discussion with healthcare teams,” NINR Director Patricia A. Grady said in a written statement.

The resources, which include a fact sheet, a resource card to help families find support, and a series of family stories, are available in both Spanish and English. The NINR developed these materials with feedback from parents of seriously ill children. To learn more, click here

[email protected]