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Pharmaceuticals / Regulatory Affairs / Postmarket Safety

House Panel Seeks Answers on Blood Thinner

Sept. 11, 2015
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Leaders of the House Energy & Commerce Committee are asking FDA Acting Commissioner Stephen Ostroff to explain what steps the agency is taking to address safety concerns around  the blood thinner Coumadin and its generic version, warfarin.

The panel’s concerns stem from a recent ProPublica report that found 165 nursing home-related hospitalizations or deaths caused by errors involving the drug between 2011 and 2014. The report said thousands more injuries occur each year that aren’t investigated by the government.

In last week’s letter, committee Chairman Fred Upton (R-Mich.) and ranking member Frank Pallone (D-N.J.) said that while the FDA has no role in overseeing nursing homes, there may be further actions it could take to decrease the incidence and severity of adverse events related to use of the drugs.

The lawmakers asked Ostroff to respond by Sept. 16 with the following information:

  • A comprehensive list of adverse events associated with Coumadin and warfarin by calendar year, starting with 2010, and whether adverse events have been increasing;
  • Any safety activities the FDA has conducted relating to the drugs since 2010;
  • Any analyses of safety issues associated with the drugs;
  • Specific steps the agency is taking to address these issues; and
  • Any changes to the labeling or black box warning that are being considered.

In July, HHS sent a memorandum to health inspectors nationwide alerting them to be on the lookout for errors at nursing homes involving Coumadin. The department also named anticoagulants as the drug category most frequently implicated in adverse events in a 2014 review. The committee wants to know what role the FDA had in this review as well.

A 2007 peer-reviewed study in The American Journal of Medicine estimated that nursing home residents suffer 34,000 fatal, life-threatening or serious events related to Coumadin or its generic counterparts each year.

Warfarin, marketed by Bristol-Myers Squibb under the brand name Coumadin, is the most widely used anticoagulant in the U.S.  

View the committee’s letter at www.fdanews.com/09-03-15-ECCoumadinLetter.pdf. HHS’ memo to inspectors is at www.fdanews.com/09-04-15-CoumadinHHS.pdf. — Kellen Owings