Gastroenterology

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Prilosec OTC Approved for Frequent Heartburn

KEY POINT

A newly defined disorder, frequent heartburn, is the FDA-approved indication for nonprescription omeprazole magnesium (Prilosec OTC—Procter & Gamble). As part of this approval, FDA has defined frequent heartburn as symptoms of substernal pain or discomfort in the upper abdominal region or need for heartburn medications on 2 or more days per week. For patients purchasing Prilosec OTC, proper use—one dose before the first substantial meal of the day for exactly 14 days—should be reinforced.

SOURCES

FDA talk paper on Prilosec. OTC http://www.fda.gov/bbs/topics/news/2003/NEW00916.html

Prilosec OTC Web site. http://www.prilosecotc.com/index.jsp