In mid-November, the FDA came out with a strong warning against using Prilosec (omeprazole) in combination with the anti-clotting drug Plavix (clopidogrel).
On the surface, the reasoning appeared to be sound. There was theoretical concern that that when patients take both Prilosec (or another PPI) and Plavix, the latter drug's ability to stop blood clots from forming might be reduced by half.
Plavix does not have anti-clotting effects until it is metabolized in the liver by an enzyme that may be blocked by Prilosec, hence the concern. No research has yet been published, though apparently enough of a negative impact on combining the drugs has been discovered to prompt the reaction.
Not so fast. While the news media ran with this announcement and began bashing the drug combo and suggested older alternatives to Prilosec and Nexium and other PPIs, at the same time, the American College of Cardiology and the American Heart Association issued a joint statement noting that the data referred to by the FDA was not yet “peer-reviewed and published.”
Not only that, but the FDA overlooked the recent randomized placebo-controlled trial, known as COGENT, which studied exactly this question and found that the combination did not lead to adverse events like heart attacks or strokes.
When the smoke clears in the world of clinical research, a correction may be issued by the FDA, but in the meantime, the news media has pounced, and a significant amount of damage has been done.Marc Siegel, MD, is an internist and professor of medicine at New York University and the author of False Alarm: The Truth About the Epidemic of Fear