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:
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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