FDA Strengthens Warnings for OxyContin

FDA Strengthens Warnings for OxyContin

Because of continuing reports of abuse, the FDA has strengthened the warnings and precautions sections in the labeling of OxyContin controlled-release tablets, a narcotic drug approved for the treatment of moderate to severe pain. Some of these reported cases have been associated with serious consequences, including death.

OxyContin contains oxycodone HCl, an opioid agonist with addiction potential similar to that of morphine. Opioid agonists act by attaching to specific proteins called opioid receptors, which are found in the brain, spinal cord, and gastrointestinal tract. When these drugs attach to certain opioid receptors in the brain and spinal cord, they can effectively block the transmission of pain messages to the brain.

OxyContin is a controlled substance in Schedule II of the Controlled Substances Act (CSA), which is administered by the Drug Enforcement Administration (DEA). Schedule II provides the maximum amount of control possible under the CSA for approved drug products. (For more on the classes--or schedule--of drugs, see "Controlled Substances".)

To educate health-care providers about the risks of OxyContin, Purdue Pharma of Stamford, Conn., manufacturer of the product, has issued a warning in the form of a "Dear Health Care Professional" letter, which will be distributed to physicians, pharmacists, and other health-care professionals. The letter highlights the problems associated with OxyContin abuse and explains the changes to the labeling, including proper prescribing information.

OxyContin, like morphine, has a high potential for abuse. It is supplied in a controlled-release dosage form and is intended to provide up to 12 hours of relief from moderate to severe pain. The tablet must be taken whole and only by mouth. When the tablet is crushed and its contents are injected intravenously or snorted into the nostrils, the controlled release mechanism is defeated and a potentially lethal dose of oxycodone is released immediately.

The FDA has worked with Purdue to make specific changes to the OxyContin labeling. The new labeling is intended to change prescription practices, as well as increase the physicians' focus on the potential for abuse and misuse. Changes include a "black box warning," the strongest type of warning for an FDA-approved drug. The new warnings are intended to lessen the chance that OxyContin will be prescribed inappropriately for pain of lesser severity than the approved use or for other disorders or conditions inappropriate for a Schedule II narcotic.

The FDA-approved use for OxyContin is for the treatment of patients with moderate to severe pain who are expected to need continuous opioids for an extended time. An important factor that must be considered in prescribing OxyContin is the severity of pain that is being treated, not simply the disease causing the painful symptoms.

The FDA continues to recommend that appropriate pain control be provided to patients who are living with severe pain. Although abuse and misuse are potential problems for all opioids, including OxyContin, opioids are very important treatment options for pain management when used appropriately under the careful supervision of a physician.

Because of the ongoing problem of OxyContin abuse and diversion, the FDA has met with the DEA, the Substance Abuse and Mental Health Services Administration, the National Institute on Drug Abuse, Purdue Pharma, and others. The FDA will continue to monitor reports of abuse and misuse of OxyContin and other opioids, and will work with other federal agencies and drug manufacturers to help ensure that these important drugs remain available to appropriate patients.

Because opioids are subject to abuse, the FDA is encouraging all manufacturers of opioids sold in the United States to review voluntarily, and revise as necessary, their products' labeling to provide adequate warnings and precautions regarding these risks and to promote responsible prescribing practices.

For more information, patients and health-care providers can call Purdue Pharma at 1-800-745-7445, or go to the FDA's Web site at www.fda.gov/cder/drug/infopage/oxycontin and OxyContin-medication Page One.