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Boxed warning added to blood thinner drug

The Food and Drug Administration (FDA) is adding its strongest product liability warning to the label for the drug Plavix. The warning will caution that some patients do not respond to the blockbuster blood thinner. The Los Angeles Times reported that the boxed warning indicates that the drug is dangerous only in the sense that it does not work in certain patients and may leave them vulnerable to heart attacks and strokes. Last year, the FDA warned that popular drugs like Prilosec or Nexium can weaken the effect of Plavix. Plavix is used for prevention of vascular ischaemic events, acute coronary syndrome, and for the prevention of thrombosis after placement of a stent. Plavix is marketed worldwide in nearly 110 countries, with sales in the United States of $6.6 billion in 2009. It has been the 2nd top selling drug in the world for a few years as of 2007.

The FDA regulates almost every facet of prescription drugs – testing, manufacturing, labeling, advertising, marketing, efficacy, and safety. A drug that is approved by the FDA is said to be “safe and effective when used as directed.” The product liability attorneys at Levin & Perconti try to keep our Chicago attorneys updated on drug safety or recalls. Earlier this year, the FDA added new product liability health warnings to Meridia, a popular diet and weight loss drug. Although European Medicines Agency advised physicians and pharmacists in Europe to stop using the drug altogether, the FDA added a warning stating that the drug is associated with an increased risk of heart attack and stroke in people who use the drug and have a history of heart problems.

To read more about the added boxed warning to Plavix, click here.