U.S. FDA Finds No Heart Impact of Prilosec, Nexium

December 11th, 2007 | by David Reiner, M.D. |

                               

Recent studies done on the popular anti-acid medications such as Prilosec and Nexium raised a concern about a possible association between these drugs and the development of heart related problems such as heart attack.  The Food and Drug Administration in early August released information about a formal drug review that was initiated, after two studies they reviewed suggested a greater risk of heart attacks, heart failure and heart related sudden death from these drugs compared to a surgical remedy for severe acid reflux disease.

U.S. regulators have released their findings where they found no evidence of increased risk of heart related problems from these popular heartburn or anti-acid medications.  The FDA based its opinion in part on 14 studies of Prilosec, the oldest drug of this class of Proton Pump Inhibitors.  Four of these studies were placebo-controlled studies(studies where half the participants get dummy pills).  Placebo controlled studies are viewed as the “gold standard” for clinical trials.

Reference: Reuters Health Information (2007-12-10)

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