FDA Says Prilosec and Nexium Not a Heart Risk

The FDA has confirmed an earlier assessment that there is no evidence of an increased risk of heart attacks or other heart problems with AstraZeneca’s gastrointestinal drugs Prilosec and Nexium.

The agency issued a MedWatch alert in August, saying that the drugs did not appear to increase the risk of serious cardiovascular adverse events, but it was still considering whether to take any regulatory action on the products.

The FDA’s August MedWatch statement will be archived on the agency’s website, and a notice appended that there is an update on the subject, but it will not be removed, Paul Seligman, CDER’s associate director for safety policy and communication, said. In that statement, the agency said concerns began when a 14-year randomized study found that patients taking Prilosec (omeprazole) to treat gastroesophageal reflux disease experienced more heart attacks, heart failure and heart-related sudden death than patients who received surgery.

The agency has completed its comprehensive scientific review of known safety data for Prilosec and Nexium (esomeprazole magnesium). It received safety data from two small long-term studies of both drugs May 29, but as the study protocols did not specify how heart problems like heart attacks were defined or verified, evaluating the safety information was challenging, the agency said.

The agency added that its assessment of the safety data gathered was further supported by an analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled. Although these studies were not specifically conducted to assess the risk of heart problems and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with either drug, the agency concluded.