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Purdue Pharma Pulls OxyContin Ads After Warning from FDA

By Lindsay F. Wiley [Bio]

January 25, 2003 — Purdue Pharma has agreed to discontinue medical journal advertisements for OxyContin that the FDA has alleged to be misleading and has promised that all future ads for the drug will include prominent warnings about its addictive potential. In response to the complaints from consumers, the FDA warned Purdue that recent advertisements failed to include adequate notification about "potentially fatal risks associated with OxyContin."

The FDA complainants were Chelly Griffith of Iowa, who became addicted to OxyContin after she was given a prescription and Marianne Skolek of New Jersey, whose 29-year-old daughter died of an OxyContin overdose. Thomas Abrams, the FDA's director of drug marketing, faxed a warning letter to Purdue stating that two recent ads in the Journal of the American Medical Association violated regulations. Abrams charged that the ads "omit and minimize the serious safety risks associated with OxyContin and promote it for uses beyond which have been proven safe and effective." The agency has warned that it will continue to evaluate other aspects of the OxyContin promotional campaign and that failure to change future ads could result in criminal prosecution.

The FDA letter marks a new level of federal involvement in the OxyContin controversy. OxyContin users and their families have filed nearly 180 lawsuits nationwide charging Purdue with designing misleading ads that contributed to abuse of the drug. The company has had 19 such lawsuits dismissed and has yet to lose or settle a single case.

Pain Management Specialists praise OxyContin's unique time-release mechanism, which eliminates the need to take pills constantly. But when patients are not carefully taken off the drug by their doctors, they can become addicted. OxyContin has also become popular as a street drug among addicts who disable the time-release mechanism by crushing the pills.