On July 1, 2010, the FDA publicly posted a warning letter to Cornerstone Therapeutics Inc. regarding the content on a patient website and an HCP visual aid for the asthma treatment Zyflo CR® extended-release tablets. The letter criticizes the omission of risk information on the website and the use of outdated product information. The site displays efficacy claims but limits safety and risk information to a link to outdated product information. The brochure is accused of minimizing risk information, exclusion of material facts, and unfounded superiority claims. Marketers should be sure that accurate, up-to-date safety and risk information is integrated into website content and not simply available one click away.
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