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OTC Treatment Of Nighttime Heartburn Partially Helpful - Gastroenterologist

This article was originally published in The Tan Sheet

Executive Summary

Self-treatment of nighttime heartburn with OTC drugs will protect only about one-third of sufferers from potentially serious medical conditions, Donald Castell, MD, The Graduate Hospital, Philadelphia, opined Aug. 24.

Self-treatment of nighttime heartburn with OTC drugs will protect only about one-third of sufferers from potentially serious medical conditions, Donald Castell, MD, The Graduate Hospital, Philadelphia, opined Aug. 24.

Antacids and H2 antagonists can help alleviate symptoms, but also can mask evidence of advanced conditions, Castell suggested, and prevent people from seeking a physician's care. If proton pump inhibitors (PPIs) were made available OTC, more people could get by without physician-guided treatment, but most still would risk later complications, he added.

Castell, a former president of the American Gastroenterological Association, intends to voice his concerns at the Oct. 20 joint meeting of FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees, which will address AstraZeneca's application to switch Prilosec, a PPI (1 (Also see "Prilosec 24-Hour Acid Control Would Be Unique To OTC Category" - Pink Sheet, 28 Aug, 2000.)).

Castell expressed concern that advertising for OTC drugs had "a tendency to trivialize heartburn," although he endorsed the use of the remedies as a "relatively inexpensive" therapy compared to Rx drugs. He also noted his "dismay" over the advent of direct-to-consumer advertising for prescription products.

Castell presided over the Aug. 24 announcement of a Gallup poll revealing a high prevalence of nighttime heartburn among Americans and the launch of the "Nighttime Heartburn Relief Effort" for consumers and primary care physicians.

The survey was funded by American Home Products subsidiary Wyeth-Ayerst, which markets the prescription PPI Protonix, while AHP's Whitehall-Robins unit markets the OTC H2 antagonist Axid AR.

Of the 1,000 adult heartburn sufferers questioned between February and April, 72% used drugs to treat symptoms, 47% used OTCs alone, 15% used OTCs with Rx drugs and 38% solely used Rx drugs. Thirty-nine percent said they "strongly agree" they keep OTCs near their bed and 45% strongly agree "current remedies don't relieve all symptoms."

AGA estimates more than 60 mil. people in the U.S. experience heartburn and 47.4 mil. suffer from nighttime heartburn, which can lead to severe esophageal disorders, including cancer.

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