Pharmaceutical

FDA approves generic versions of blood thinner Plavix

blood cells1 FDA approves generic versions of blood thinner PlavixThe Food and Drug Administration (FDA) has approved generic versions of the blood thinner Plavix (clopidogrel bisulfate), which is used to reduce the risk of heart attack and stroke in patients who have had a recent heart attack or stroke, or have partial or total blockage of an artery, also known as peripheral artery disease.

Clopidogrel has a boxed warning to alert health care professionals and patients that the drug may not work well for those with certain genetic factors that affect how the body metabolizes the drug. Patients can be tested for these genetic factors to ensure that clopidogrel is the right choice for them.

Also, certain medicines, such as proton pump inhibitors Prilosec (omeprazole) and Nexium (esomeprazole), reduce the effect of clopidogrel, leaving a person at greater risk for heart attack and stroke.

Clopidogrel, like all blood thinners, may cause bleeding, which can be serious and sometimes lead to death. While taking the drug, people may bruise and bleed more easily, be more likely to have nose bleeds, and it may take longer for all bleeding to stop.

In 2010, the FDA approved the blood thinner Pradaxa, used to prevent strokes in patients with a type of irregular heartbeat called atrial fibrillation. It was the first blood thinner for that specific use to be approved by the FDA since warfarin more than 50 years ago.

However, recent studies show Pradaxa may put users at even greater risk for internal bleeding events, which in some cases have been fatal. The safety of Pradaxa is currently under review by the FDA.

Source: FDA