Drug Information

OxyContin Information:
FDA Strengthens Warnings for OxyContin

FDA has strengthened the warnings and precautions sections in the labeling of OxyContin (oxycodone HCl controlled-release) Tablets, a narcotic drug approved for the treatment of moderate to severe pain.

In recent months, there have been numerous reports of OxyContin diversion and abuse in several states. Some of these reported cases have been associated with serious consequences including death. In an effort to educate health care providers about these risks, Purdue Pharmaceuticals, manufacturer of the product, has issued a warning in the form of a "Dear Healthcare Professional" letter. The "Dear Healthcare Professional" letter will be distributed widely to physicians, pharmacists, and other healthcare professionals.

• U.S. General Accounting Office releases its report, “Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem." GAO Report. (1/22/2004)
• OxyContin Talk Paper (7/25/2001)
• OxyContin Questions and Answers (7/25/2001)
• FDA Approval Letter (7/25/2001)
• OxyContin Drug Label.  Optional Format: PDF (7/25/2001)
• Dear Healthcare Professional Letter (7/26/2001)
• Prescription Drug Abuse.  Article from FDA Consumer magazine, Sept-Oct, 2001
• Consumer Education: Misuse of medicines.

Back to Top   Drug Information

FDA/Center for Drug Evaluation and Research
Last Updated: January 22, 2004
Originator: OTCOM/DLIS
HTML by PKS