Another Plavix - Prilosec Warning Coming from FDAOct 20, 2010 | Parker Waichman LLP
Plavix (clopidogrel) users will again be cautioned not to take the proton pump inhibitor Prilosec by the US Food & Drug Administration (FDA), according to a report in The Wall Street Journal. The agency still has concerns that Prilosec can inhibit the ability of Plavix to prevent blood clots.
Proton pump inhibitors like Prilosec are often prescribed to Plavix patients to minimize gastric effects such as nausea and heartburn. Last November, the FDA first warned that people taking Plavix should avoid Prilosec because of data indicating the heartburn drugs could interfere with the effectiveness of Plavix. In March, a black-box warning – the FDA’s strongest safety warning – was added to Plavix’s label warning of “diminished effectiveness” in patients who metabolize the drug poorly, including those who take Prilosec.
According to The Wall Street Journal, a study published this month in The New England Journal of Medicine suggested patients taking both drugs were at no greater risk of serious cardiovascular events than those taking Plavix alone.
After the study was published, Mary Ross Southworth, an FDA official overseeing the safety of cardiovascular products, told the Journal that some doctors may have misinterpreted that study. She and Ellis Unger, a colleague at the FDA, maintained that the study was too small to be meaningful and used a delayed-release version of Prilosec that is not available to patients.
Now, according to the Journal, Southworth and Unger said the FDA is concerned that the study published this month will lead doctors and patients to make what they described as the wrong decision. As such, the agency plans to issue a reminder to doctors and other health-care providers about the possible risks of taking Prilosec along with Plavix.
The Wall Street Journal also points out some interesting facts about the recent study – called Cogent- that is causing the FDA so much concern:
“The original sponsor of the Cogent study, Cogentus Pharmaceuticals Inc., went bankrupt in early 2009. Cogentus’s major product in development was a drug that essentially combines Plavix and a form of Prilosec.
According to The Wall Street Journal, Cogent was finished partly through voluntary work by researchers who didn’t want their early efforts wasted.