July 25, 2001
FDA Strengthens Warnings For Oxycontin
WASHINGTON, D.C - 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, because of continuing reports of abuse and diversion.
OxyContin contains oxycodone HCL, an opioid agonist with an addiction potential similar to
that of morphine. Opioid agonists are substances that 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.
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. The letter explains the changes to the labeling including proper
prescribing information and highlights the problems associated with the abuse and
diversion of OxyContin.
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
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, misuse, and diversion.
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 indication 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 the
pain that is being treated, not simply the disease causing the painful symptoms.
FDA continues to recommend that appropriate pain control be provided to patients who are
living with severe pain. Although abuse, misuse, and diversion are potential problems for
all opioids, including OxyContin, opioids are a very important part of the medical
armamentarium for the management of pain when used appropriately under the careful
supervision of a physician.
Because of the ongoing problem of OxyContin abuse and diversion, FDA has met with DEA, the
Substance Abuse and Mental Health Service Agency, the National Institute on Drug Abuse,
Purdue, Inc., and others. FDA will continue to monitor reports of abuse, misuse, and
diversion 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
Since all opioids are subject to abuse, misuse, and diversion, FDA is encouraging all
manufacturers of opioids sold in the U.S. to review voluntarily, and revise as necessary,
their product's labeling to provide adequate warnings and precautions regarding these
risks and to promote responsible prescribing practices.
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