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  5. Drug Safety Oversight Board Meeting<br /> November 20, 2014
  1. Center for Drug Evaluation and Research | CDER

Drug Safety Oversight Board Meeting<br /> November 20, 2014

Public Summary

The following Drug Safety Communications (DSCs) have posted since the July 17, 2014 DSB meeting:

  • September 26, 2014: Xolair (omalizumab) - FDA is providing an update to the Early Communication about an ongoing safety review of Xolair. The review of safety studies for Xolair suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair than in those who were not treated with Xolair. As a result, FDA has added information about these potential risks to the drug label. Patients taking Xolair should continue to take the medication as prescribed and discuss any questions or concerns with their health care professionals.
  • November 16, 2014: FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death - FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicinedisclaimer icon on November 16, 2014. FDA has not reviewed the trial results or reached any conclusions based on the findings from this clinical trial. FDA will communicate is final conclusions and recommendations when its evaluation is complete. 

The Board heard two presentations:

  1. CDR Emily Thakur, RPh,Team Leader, Drug Shortage Staff/CDER presented an overview of FDA drug shortage management and discussed the status of some specific shortages.
  2. Jodi Schipper, JD, and Barbara Wise, PhD, Office of Unapproved Drugs and Labeling Compliance/OC/CDER presented an overview of the Unapproved Drugs Initiative.

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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