Ongoing Review of Safety Data for Prilosec and Nexium

Posted on April 29, 2008

December 11, 2007
UPDATE: FDA has now completed its' comprehensive review of known safety data for the drugs Prilosec (omeprazole) and Nexium (esomeprazole). FDA's conclusion continues to be that long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that healthcare providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.

October 2007
FDA is continuing to review new safety data for the proton pump inhibitors Prilosec and Nexium, which are used to treat severe gastroesophageal reflux disease (GERD).

These data came from two small long-term clinical studies where patients with severe GERD were assigned to be treated with Prilosec or Nexium or to receive surgery. The results 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 patients on drug therapy compared to those who received surgery.

After reviewing these studies, along with other information submitted by the company, FDA's preliminary conclusion is that taken together, these data do not suggest an increased risk of heart problems for patients treated with Prilosec or Nexium. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.

Additional Information:

FDA MedWatch Safety Alert. Omeprazole (marketed as Prilosec and generic products) Omeprazole + Sodium Bicarbonate (marketed as Zegerid) Nexium (esomeprazole). December 11, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Omeprazole