FDA Consumer - Combination drug treatment approved for ulcers - Food and Drug Administration approves use of Biaxin, or clarithromycin, and Prilosec, or omeprazole, to treat…
The first antibiotic treatment for eradicating Helicobacter pylori, the bacteria associated with active duodenal ulcers, has been approved by FDA.
The treatment involves taking two previously approved drugs: Biaxin (clarithromycin) and Prilosec (omeprazole). It was approved April 18.
Biaxin, manufactured by Abbott Laboratories, is an antibiotic for various mild to moderate infections. Prilosec, manufactured by Astra Merck, is a proton pump inhibitor that helps heal ulcers by suppressing gastric acid. In combination, the two drugs are effective in healing active duodenal ulcers and reducing the risk of ulcer recurrence. This combination treatment, however, is not effective against other bacteria associated with ulcers.
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In 1994, a National Institutes of Health consensus panel of medical experts made a landmark recommendation in support of an antibiotic-based approach for treating ulcers. FDA used the recommendation to advise companies on the best trial designs for developing these therapies.
In one foreign and two U.S. randomized studies, the most effective dosage levels were Biaxin at 500 milligrams three times a day plus Prilosec at 40 mg once a day for two weeks, followed by Prilosec at 20 mg once a day for two more weeks.
Although study participants reported few side effects, mild to moderate cases of taste distortion, nausea, headache, diarrhea, vomiting, and abdominal pain did occur.
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