Joint FDA Advisory Committee Recommends Approval of Prilosec (Omeprazole) for OTC Switch at Full Prescription Strength

US Food and Drug Administration

A June 21, 2002, announcement from a joint session of the Nonprescription Drugs Advisory Committee and Gastrointestinal Drugs Advisory Committee to the US Food and Drug Administration (FDA) voted to recommend Prilosec (omeprazole) be approved for over-the-counter (OTC) use at full prescription strength for the prevention of frequent heartburn symptoms. Prilosec belongs to the class of drugs called proton pump inhibitors (PPIs), which deactivate the acid pumps in the cells of the stomach for up to 24 hours. If approved, OTC Prilosec can be taken once daily as part of a 14-day regimen. The committee's decision was based on the Prilosec's safety and efficacy records since coming on the US market in 1989. More than 11,000 people have been studied in clinical trials for OTC approval. From 1996-2000, Prilosec was the top-selling prescription medication in the world and at any point during that time, there were more than 10 million patients taking prescription Prilosec for a range of acid-related disorders. The most common side effects of prescription Prilosec are headache, diarrhea, and abdominal pain. Side effects of Prilosec were transient and mild compared to placebo. Full prescribing information for Prilosec is available at www.prilosec-us.com. The full press release is available here. US Food and Drug Administration (taken from press releases from AstraZeneca LP and Procter & Gamble) Return to Top