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  5. Drug Safety Oversight Board Meeting, January 16, 2014
  1. Center for Drug Evaluation and Research | CDER

Drug Safety Oversight Board Meeting, January 16, 2014

Public Summary

The following Drug Safety Communications (DSCs) have posted since the November 21, 2013 DSB meeting:

  • November 25, 2013: Rosiglitazone-containing medications – FDA has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea.  As a result, we are requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010.  This decision is based on our review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI).
  • December 3, 2013: Onfi (clobazam) - FDA is warning the public that the anti-seizure drug Onfi can cause rare but serious skin reactions that can result in permanent harm and death.  FDA has approved changes to the Onfi drug label and the patient Medication Guide to describe the risk of these serious skin reactions. Patients taking Onfi should seek immediate medical treatment if they develop a rash, blistering or peeling of the skin, sores in the mouth, or hives. Health care professionals should discontinue use of Onfi and consider an alternate therapy at the first sign of rash, unless it is clearly not drug-related.  
  • December 17, 2013: Methylphenidate ADHD products - FDA is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism. FDA continues to monitor the safety of drugs after they are approved, and, based on a recent review of methylphenidate products, has updated the drug labels and patient Medication Guides to include information about the rare but serious risk of priapism. Patients who take methylphenidate and develop erections lasting longer than four hours should seek immediate medical treatment to prevent long-term problems with the penis. If not treated right away, priapism can lead to permanent damage to the penis.
  • December 20, 2013: Iclusig (ponatinib) – FDA issued a DSC update concerning the marketing resumption of the leukemia drug Iclusig. FDA is requiring several new safety measures for the leukemia drug Iclusig (ponatinib) to address the risk of life-threatening blood clots and severe narrowing of blood vessels. Once these new safety measures are in place, the manufacturer of Iclusig is expected to resume marketing to appropriate patients.  The required safety measures involve label changes to narrow the indication, provide additional warnings and precautions about the risk of blood clots and severe narrowing of blood vessels, revise recommendations about dosage and administration of Iclusig, and update the patient Medication Guide. FDA is also requiring a risk evaluation and mitigation strategy (REMS). In addition, the manufacturer of Iclusig, ARIAD Pharmaceuticals, must conduct postmarket investigations to further characterize the drug’s safety and dosing.
  • January 8, 2014: OTC Sodium Phosphate products – FDA is warning that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death. OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally. Health care professionals should use caution when recommending an oral dose of these products for children 5 years and younger. The rectal form of these products should never be given to children younger than 2 years. FDA has become aware of reports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose of OTC sodium phosphate products, resulting in serious adverse effects on organs, such as the kidneys and heart, and in some cases resulting in death. These serum electrolytes include calcium, sodium and phosphate. According to the reports, most cases of serious harm occurred with a single dose of sodium phosphate that was larger than recommended or with more than one dose in a day. 

The DSB heard opening remarks from the CDER Center Director and discussed three topics:

Janet Woodcock, CDER Center Director, addressed the Board to thank them for the feedback provided on a myriad of CDER issues and challenges in 2013.

Jane Axelrad, Associate Director for Policy, CDER, and the Agency lead on pharmacy compounding, provided an update to the DSB concerning the recent passage of the pharmacy compounding legislation and its implementation.

Virginia Torrise, Deputy Chief Consultant, Professional Practice, Pharmacy Benefits Management Services, Office of Patient Care Services, VHA, presented Outsourcing Compounded Sterile Products (CSP): A VA Review.

Theresa Toigo, Associate Director for Drug Safety Operations, CDER discussed the DSB Evaluation Project and the proposed DSB Mission Statement.

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


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