FDA Finds Initial Inquiries Into Prilosec Inconclusive

Courtney Mills

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The U.S. Food and Drug Administration has issued some preliminary findings concerning a study on omeprazole(Prilosec) and an ongoing study on esomeprazole(Nexium). The FDA based the findings on small sets of data received from two small, long-term clinical studies by AstraZeneca, the makers of Prilosec.

In the study, patients were either randomly assigned treatment for severe gastroesophageal reflux disease (GERD) with Prilosec, Nexium, or gastric bypass surgery to assuage the condition.

Patients taking either Prilosec or Nexium were shown in a cursory analysis of the data to have a marked increase in heart-related conditions, heart attacks, and death due to heart failure compared to those who underwent surgery to correct the condition.

The FDA underscored that this information is preliminary and is an early communication about the safety of proton pump inhibitors, and that patients should not discontinue their medication regime before speaking to a physician.