FDA Says Heartburn Drugs May Interfere with Plavix

The Food and Drug Administration officials issued a Public Health Advisory regarding Plavix and OTC heartburn medications, especially Prilosec and Nexium. The heartburn medications can interfere with the effectiveness of Plavix, a blood thinner taken by millions of people to reduce stroke and heart attack risks. The FDA said Prilosec and Nexium reduced the effectiveness of Plavix’s blood-thinning capabilities by half. FDA regulators said that the active ingredient in the popular heartburn pharmaceuticals potentially put some people at risk by blocking an enzyme that the body needs to break down Plavix (clopidogrel).

“Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine,” the FDA said in a statement.

Plavix is the second-best selling pharmaceutical in the world, with Sanofi-Aventis and Bristol-Myers Squibb having sold $8.6 billion of the blood thinner in 2008. Only Pfizer’s cholesterol drug, Lipitor, is more popular. Plavix is a drug that can upset the stomach and physicians often prescribe it with acid-blocking heartburn drugs such as Prilosec and Nexium to reduce discomfort. The FDA’s announcement will likely cause doctors who write Plavix prescriptions to recommend pharmaceuticals from the H-2 family of drugs.

Blood thinners, Prilosec and Nexium belong to a class of drugs called proton pump inhibitors. FDA officials said that except for these two drugs, they did not yet have enough information to say whether other proton pump inhibitors should not be taken along with Plavix. Mary Ross Southworth, FDA’s deputy director for safety of cardiovascular products, said, “There’s not enough data to tell us how those drugs interact with [the enzyme that activates Plavix. There are ongoing studies looking at those other drugs.” The FDA based its findings on a study involving 150 patients submitted in summer 2009 by Sanofi-Aventis.

The manufacturer and purveyor of a defective product can be held liable for any loss, damage or injury caused by the use of their defective product. Product liability rulings by courts in Florida and elsewhere against the manufacturers of defective products have enhanced public safety. However, as this article indicates, defective pharmaceutical drugs still present potentially serious risks to people who take them.

If you or someone you care for sustained injury by taking Plavix in conjunction with Prilosec and Nexium, Orlando product liability attorney James O. Cunningham may be able to help. His expertise in product liability cases assists clients in the recovery of damages from the manufacturers of defective products. He has practiced personal injury law since 1977 and has the experience to represent clients against large corporations. To schedule a free consultation with Orlando product liability lawyer James O. Cunningham, call any of his Central Florida law offices today.