Do PPIs Increase the Risk of Cardiovascular Disease? Probably Not

Implications: "The FDA announced that studies of two prescription proton-pump inhibitors, omeprazole (Prilosec) and esomeprazole (Nexium), had raised concerns about their cardiovascular safety. In the same announcement, the agency said its preliminary assessment was that the problems seen in those studies were "not a true effect." But a final safety report remained three months away."  Thus reads a truly bad piece of medical reporting!

Analysis: This brief article is really a perversion of the FDA statement.  In fact, the FDA reviewed this issue after AstraZeneca indicated to the FDA that two small studies of these agents suggested an increased cardiovascular risk.  The FDA followed up on those studies and suggested the heart link was a coincidence.  The FDA examined 14 additional studies of the drugs, and found no evidence of heart risks. In fact, in a few studies where patients received either the PPI or a placebo, those who took the heartburn drugs had a lower incidence of heart problems. The true statement said that the analaysis would be completed within three months, but issued a public notice that it "does not believe that health care providers or patients should change either their prescribing practices or their use of these products at this time."
The FDA acted responsibly in this case.