A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events. According to the Food & Drug Administration FDA’s MedWatch:
Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. FDA is working to determine whether reports of bleeding are occurring more commonly than would be expected.
For more information on the drug or medical device recall or safety alert, read the Food & Drug Administration’s FDA’s drug or medical device recall or safety alert: Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events.
To report an adverse reaction, problem or other issue with a drug or medical device, submit a drug or medical device complaint to the government at fda.gov or MedWatch.
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