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Astra Prilosec

Executive Summary

Promotional materials for triple combination therapy of Prilosec (omeprazole), Biaxin (clarithromycin) and amoxicillin overstates efficacy of the Helicobacter pylori regimen, FDA maintains in a May 21 letter. The statement in a "patient information pak" that "If you stop taking your medicines too soon and don't eliminate all the H. pylori, your ulcer is likely to return" implies that patients' ulcers will not return, which is misleading, FDA notes. The agency points out that in clinical trials, the eradication rate was 5% to 35%. "These recurrence rates indicate that patients in whom the H. pylori organism has been eradicated may still experience a recurrence of their duodenal ulcer," FDA says. The letter also cites the company for selectively presenting more favorable efficacy rates for triple therapy with Prilosec of 77% to 90%, when clinical trials showed a wider range of efficacy from 69% to 90% by intent-to-treat analysis. The pak box also fails to present information on contraindications for the triple therapy

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