The latest news about stomach drugs could give Plavix users a serious case of heartburn. The FDA shocked folks at the American Heart Association meeting with a warning that using the heartburn meds Prilosec and Prilosec OTC interferes with the anti-clotting effects of the blockbuster blood thinner. In fact, the combo cuts the efficacy of Plavix almost in half.
At a press conference yesterday, the FDA explained that it had analyzed new, unpublished data from Sanofi and concluded that Plavix's label needed changing. Luckily for Sanofi and its Plavix partner Bristol-Myers Squibb, there's no evidence that other heartburn meds--namely, those that don't inhibit the liver enzyme CYP2C19 as Prilosec does--interfere with the blood thinner's work.
Unfortunately for the makers of other CYP2C19 inhibitors besides Prilosec, FDA says that they also shouldn't be used in combination with Plavix. These include the heartburn blockbusters Nexium and Tagament, and even the psychiatric drugs Prozac, and antidepressant, and Luvox, used to treat social anxiety and obsessive compulsive disorder. The agency says it doesn't know whether other proton-pump inhibitors such as Protonix interfere with Plavix.
As the Wall Street Journal points out, one cardiology society had already warned doctors about the risks of combining Plavix with Prilosec and its ilk. Some public health types protested that the FDA's alert came too late and, as a non-"black box" warning, was too mild. But the warning still came as a stunner to many, because recent research had concluded that combining Plavix with heartburn meds didn't increase risks as previous studies found. And today the AHA plans to announce new recommendations on heartburn meds.
- get the FDA advisory
- find the "Dear Healthcare Professional" letter
- see the article in the Los Angeles Times
- read the Wall Street Journal story
- check out the coverage at MedPage Today
ALSO: The generics arm of Swiss pharmaceutical company Novartis has launched an authorized generic version of Takeda's Prevacid, a gastroesophageal reflux disease drug. Report