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Study shows how well heartburn sufferers follow directions for over-the-counter Prilosec OTC

ANN ARBOR, MI Ever since it was first made available in September 2003, Prilosec OTC has become one of the leading over-the-counter remedies for treating frequent heartburn. Prilosec OTC contains the same active drug component (omeprazole) as prescription Prilosec.

Some health professionals have questioned whether consumers will use the over-the-counter product as intended. But research published today in the journal Clinical Gastroenterology and Hepatology shows that frequent heartburn sufferers are able to follow and comply with the directions on the package label.

"A substantial majority of people who purchased Prilosec OTC complied very well with the label instructions" said lead author, Mark Fendrick, M.D., the University of Michigan professor who led the evaluation of this study. "And, contrary to some concerns that Prilosec OTC would result in decreased physician visits, this study showed that frequent heartburn sufferers actually increased consultation with their physicians."

"The study shows that consumers can use Prilosec OTC correctly to manage their frequent heartburn", said co-author Greg Allgood, Ph.D., Associate Director at the P&G Health Sciences Institute. "This research supports the U.S. Food and Drug Administration's decision to make Prilosec OTC more readily accessible to the tens of millions of Americans with frequent heartburn."

Five shopping mall kiosks (in Modesto, CA, West Palm, FL, Vernon and Trumbull, CT, and Atlanta, GA) were set up for the study, with permission from the FDA to sell Prilosec OTC to people who agreed to enroll. The study was performed as part of P&G's application process to the FDA for permission to market Prilosec OTC as an over-the-counter drug.

More than 90 percent of consumers who decided to buy the drug had frequent heartburn, the condition for which Prilosec OTC has FDA approval. Only 3 percent took more than the recommended 14 daily doses, even though they had the opportun
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Contact: Kara Gavin
kegavin@umich.edu
734-764-2220
University of Michigan Health System
9-Jan-2004


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