FDA Clears New Labelling For Prilosec

Astra Merck has received clearance from the US Food and Drug Administration to revise the labelling for its proton pump inhibitor Prilosec (omeprazole) following review of data resolving previous questions about long-term safety. Late last year the company presented to the FDA's Gastro-intestinal Drugs Advisory Committee data demonstrating the relative safety of Prilosec in clinical studies of up to eight years, as well as experience with millions of patients worldwide since the drug was first marketed.

Prilosec is indicated for the short-term treatment of symptomatic gastro-esophageal reflux disease (GERD) that is poorly responsive to customary medical treatment, as well as for short-term treatment of active duodenal ulcer and severe erosive esophagitis. It is also indicated for the long-term treatment of certain pathological hypersecretory conditions, such as the Zollinger-Ellison syndrome.

The FDA has recommended the removal of the qualifier "severe" from the erosive esophagitis claim, clearing the way for the unrestricted use of Prilosec in all grades of erosive esophagitis. When Prilosec was first cleared for marketing in 1989, the FDA required that the product's labelling include a "black box" warning that more data were needed in order to rule out the possibility of increased risk from long-term therapy.