FDA Preliminarily OKs Prilosec, Nexium

The U.S. Food and Drug Administration announced preliminary approval Thursday for the safety of Prilosec and Nexium.

The drugs, both manufactured by London-based Astra-Zeneca International, treat gastroesophageal reflux disease by reducing the amount of acid produced by the stomach.

Both Nexium (esomeprazole ) and Prilosec (omeprazole) are prescription drugs, although Prilosec is also sold over-the-counter for frequent heartburn.

Two small, long-term studies had indicated patients using the drugs might have an increased risk of heart attacks, heart failure or heart-related sudden death.

However, the FDA said, Astra-Zeneca had submitted a large amount of data that do not suggest an increased risk of heart problems for patients treated with either omeprazole or esomeprazole.

Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of these products at this time, the federal agency said.

The FDA said its preliminary conclusion is that the observed risk of heart attacks and other heart-related problems seen in early analyses of the two studies was not valid.