FDA releases safety review regarding Prilosec and Nexium

The FDA has issued an early communication about the ongoing review of new safety data for the proton pump inhibitors, Prilosec and Nexium, which are prescribed in the US for the treatment of gastroesophageal reflux disease (GERD), esophageal erosions and ulcers.

Prilosec is also sold OTC for frequent heartburn.

The new safety data was from two small long-term clinical studies in patients with severe GERD. In both studies, patients were randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their (GERD).

The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. 

After reviewing these and other data submitted by the company, the FDA's preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole.

The agency advises that healthcare providers should not change their prescribing practices, while patients should not change their use of these products at this time.