House of Representatives Wants More Info from FDA on the Safety of Blood Thinners

September 14, 2015


Following the release of an analytical report published by ProPublica, the House of Representatives is seeking more information regarding the safety of Coumadin, a widely-prescribed blood thinner, and its generic version, warfarin. The report stated that between 2011 and 2014, “at least 165 nursing home residents were hospitalized or died after errors involving Coumadin or warfarin”. This caused the Committee on Energy and Commerce to send a letter asking acting FDA Commissioner Dr. Stephen Ostroff, for additional information on the products.

In addition to an increased occurrence of adverse events, the article also noted that Coumadin and other anti-coagulants were identified as one of the drug categories most frequently implicated in adverse drug events.

According to the letter sent to FDA, ProPublica’s report provoked the committee to “consider whether there are any further actions FDA could take to decrease the incidence and severity of adverse events related to the use of Coumadin and/or warfarin."

The committee is seeking the following information from the Agency:

  • Summaries of adverse events associated with Coumadin and/or warfarin by calendar year, starting with calendar year 2010. In addition to any other information the agency has regarding the trends in adverse events associated with the use of Coumadin and/or warfarin, in particular whether the incidence of adverse events has been increasing.
  • If FDA conducted any safety activities relating to the safety of Coumadin and/or warfarin since January 1, 2010, the committee is asking FDA to provide a description of the activities, the dates of said activities, and the offices involved.
  • If FDA conducted any analyses of safety issues associated with Coumadin and/or warfarin, the committee is asking FDA to provide all documents relating to these analyses (including analyses of medication errors) since January 1, 2010.
  • The committee is asking FDA if it was involved in the HHS review that identified Coumadin and other anti-coagulants as one of the drug categories most frequently implicated in adverse drug events. If yes, the House would like to know FDA’s role in this effort; and if no, what was the reason?
  • What steps, if any, is FDA taking to address safety and/or medical error issues related to Coumadin and/or warfarin?
  • Since the safety labeling changes for Coumadin were approved by FDA in January 2010, has FDA considered any changes to the safety labeling or black box warning of Coumadin and/or warfarin in light of the recent issues related to the use of the product in nursing homes?

The letter was sent by Frank Pallone, Jr., Ranking Member, and Fred Upton, Chairman, along with an attachment that provided additional information regarding how to respond to the request. The letter states that FDA has until September 16, 2015 to respond to the letter with the information requested (above).

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