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Pharmaceuticals / Regulatory Affairs

FDA Denies Petition to Add Warning to Blood Thinner Labeling

Jan. 17, 2019

The FDA denied a petition from Public Citizen to add a boxed warning to the labeling for the blood thinner clopidogrel.

In its 2013 petition, the advocacy group called on the FDA to add a warning about the increased risk of bleeding with use of the drug — sold both under the brand name Plavix by Bristol-Myers Squibb and as a generic — more than 12 months after implantation of drug-eluting coronary artery stents.

“Such warning is made necessary both by a lack of evidence of a further reduction of thrombotic cardiovascular events, such as myocardial infarction or stroke, as well as existing evidence of continued risk of major bleeding with more prolonged use,” the advocacy group said.

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