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  5. Drug Safety Oversight Board Meeting - March 16, 2017
  1. Center for Drug Evaluation and Research (CDER)

Drug Safety Oversight Board Meeting - March 16, 2017

Public Summary

The following 12 Drug Safety Communications have posted since the May 19, 2016 DSB meeting:

  • February 2, 2017: Warning about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate: although rare, reports of serious allergic reactions to these products has increased over the last several years. As a result, FDA is requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels. 
  • December 16, 2016: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings: based on FDA’s review of a large clinical trial that we required drug companies to conduct, we have determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix and Zyban is lower than previously suspected. The results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines. As a result of our review of the large clinical trial, we are removing the Boxed Warning for serious mental health side effects from the Chantix and Zyban drug labels. We are also updating the existing warning section in both labels that describes the side effects on mood, behavior, or thinking to include the results from the clinical trial. The patient Medication Guide that explains the risks associated with the use of the medicines will continue to be provided with every patient prescription; however, the risk evaluation and mitigation strategy (REMS) that formally required the Medication Guide will be removed. 
  • December 14, 2016: FDA is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than three years or in pregnant women during their third trimester may affect the development of children’s brains. To better inform the public about this potential risk, we are requiring warnings to be added to the labels of general anesthetic and sedation drugs.
  • December 12, 2016: As a result of an updated review, FDA has concluded that use of the Type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and we have now approved label updates to describe the additional studies we reviewed.
  • October 4, 2016: FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. We are requiring a Boxed Warning about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines.
  • August 31, 2016: A FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and death. In an effort to decrease the use of opioids + benzodiazepines, or opioids + other CNS depressants, we are adding Boxed Warnings to the drug labeling of prescription opioid pain and prescription opioid cough medicines and benzodiazepines. Patients taking opioids with benzodiazepines, with other CNS depressant medicines, or with alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. 
  • July 26, 2016: FDA approved changes to the labels of fluoroquinolone (FQ) antibacterial drugs for systemic use. These medicines are associated with disabling and potentially permanent side effects affecting tendons, muscles, joints, nerves, and the CNS that can occur together in the same patient. We revised the Boxed Warning and Warnings and Precautions sections of FQ labels to address these serious safety issues. The Indications and Usage section contains new limitation-of-use statements to reserve FQs for patients who have no other available treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections (UTI).
  • June 14, 2016: FDA has strengthened the existing warning about the risk of acute kidney injury for the Type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. 
  • June 7, 2017: FDA is warning that taking higher than recommended doses of the OTC and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide. We continue to evaluate this safety issue and will determine if additional FDA actions are needed. https://www.fda.gov/Drugs/DrugSafety/ucm504617.htm
  • June 6, 2017: FDA is warning consumers about serious bleeding risks when using OTC aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. These widely used products already contain warnings about this bleeding risk on their labels; however, we are continuing to receive reports of this serious safety issue. As a result, we will continue to evaluate this safety concern and plan to convene an advisory committee of external experts to provide input regarding whether additional FDA actions are needed. https://www.fda.gov/Drugs/DrugSafety/ucm504328.htm
  • June 2, 2016: FDA is investigating the risk of serious burns and potential permanent scarring with the use of the Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is complete. Patients who experience moderate to severe pain at the Zecuity patch site should immediately remove it to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact your health care professional. Health care professionals should advise patients who complain of moderate to severe pain at the application site to remove the Zecuity patch immediately. https://www.fda.gov/Drugs/DrugSafety/ucm504588.htm
  • May 19, 2016: FDA is warning health care professionals to avoid prescribing ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which are not approved uses of the drug. We approved label changes for oral ketoconazole tablets in 2013 to reflect these serious risks and to remove the indication for treatment of skin and nail fungal infections.

The Board heard four presentations (one independent presentation and three presentations related to the single topic of DDIs in FDA labeling):

Communication Strategies to Reach Physicians and Measuring the Effect of Feedback on Physician Behavior (Scott Winiecki, M.D., Safe Use Initiative, Professional Affairs and Stakeholder Engagement, CDER)

Services for drug-drug-interactions (DDI) and DDI research at the National Library of Medicine (Olivier Bodenreider, M.D., Ph.D., Senior Scientist and Chief, Cognitive Science Branch, Lister Hill National Center for Biomedical Communications)

Order Checks for Drug-Drug- Interactions in Department of Veteran Affairs (C. Bernie Good, M.D., M.P.H., Chair, Medical Advisory Panel for Pharmacy Benefits Management, VA; Professor of Medicine and Pharmacy, University of Pittsburgh)

Drug Interaction Information in FDA-Approved Labeling About Metabolic Pathways and Transporter Systems (Joseph Grillo, Pharm.D., Associate Director for Labeling and Health Communication, Office of Clinical Pharmacology, Office of Translational Sciences, CDER)

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or institution.

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