• Defective Drug Side Effects

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Bristol-Meyers Squibb has strengthened the label warning on its blood-thinning drug, Coumadin, generically known as warfarin. The new label includes a black box, and warns of the increased risk of “fatal bleeding” associated with the drug''s use.

The revised label now warns within a black box, the most serious warning possible, that the drug can cause “major or fatal bleeding.”

The old label had a warning about the bleeding risk, but the caution referred to it only as a “risk of hemorrhage,” and lacked a black box around it.

Warfarin is a widely used blood thinning anticoagulant that the manufacturer claims can reduce the risk of heart attack and stroke caused by artery blockage. It does this by preventing clots from forming, or becoming larger.

The new warning also states that bleeding is more likely to occur at higher doses, or when the patient first starts taking the drug. According to the warning, those who are 65 and older, or have a history of hypertension, gastrointestinal bleeding, or serious heart disease are also more at risk.

Ken Dominski, Bristol spokesman corroborated the labeling change, and confirmed that it affected both the tablet and injection forms of the drug. He said that they worked with the FDA in implementing the change, but did not say whether the agency required the black box.

Suffered serious Coumadin or warfarin side effects? Please contact us for a consultation with a caring and experienced personal injury attorney who can protect your legal rights and help you recover your losses.