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  5. Drug Safety Oversight Board Meeting, March 20, 2014
  1. Center for Drug Evaluation and Research (CDER)

Drug Safety Oversight Board Meeting, March 20, 2014

Public Summary

The following Drug Safety Communications (DSCs) have posted since the January 16, 2014 DSB meeting:

  • January 31, 2014: Testosterone Products – A DSC was posted to alert the public that FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. FDA has been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA provided this alert while it continues to evaluate the information from these studies and other available data, and will communicate its final conclusions and recommendations when the evaluation is complete. 
  • February 11, 2014: Saxagliptin (marketed as Onglyza and Kombiglyze XR) – A limited information DSC was posted to alert the public that FDA has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure. FDA’s request resulted from a study3 published in the New England Journal of Medicine, which reported an increased rate of hospitalization for heart failure with use of saxagliptin compared to an inactive treatment. The study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin. The manufacturer is expected to submit the trial data to FDA by early March 2014, after which FDA will conduct a thorough analysis and report its findings publicly. 
  • March 6, 2014: Doribax (doripenem) – An update to a January 5, 2012 FDA Statement notifying the public that FDA has concluded that Doribax (doripenem), an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the U.S. under the name Primaxin). Based on FDA’s analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, FDA has approved changes to the Doribax drug label that describe these risks. 

The DSB meeting concerned REMS. The Board heard three presentations:

  1. Kendra Worthy, Division of Risk Management, OSE/CDER discussed the Lotronex REMS program.
  2. Somya Dunn, Division of Risk Management, OSE/CDER discussed the various REMS programs for drugs that treat pulmonary arterial hypertension.
  3. Todd Semla, National PBM Clinical Pharmacy Program Manager, and Phillip Streit, Pharmacy Program Specialist - Specialty Pharmacy, Pharmacy Benefits Management Services, VA discussed the implementation of a REMS within the VA system that has a specialty pharmacy component.

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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