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U.S. Department of Health and Human Services

Safety

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OxyContin (oxycodone HCl)

Audience: Health Professionals and Consumers

FDA and Purdue Pharmaceuticals have strengthened the warnings and precautions sections in the labeling of OxyContin, a narcotic drug approved for the treatment of moderate to severe pain, because of continuing reports of abuse and diversion. The changes are intended to reinforce proper prescription practices and increase physician focus on the potential for abuse, misuse, and diversion.

[July 25, 2001 - Letter - Purdue Pharma]
[July 25, 2001 - Label - Purdue Pharma]