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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.

Use Prescription Drugs Safely

1. Always follow medication directions carefully.
2. Don't increase or decrease doses without talking with your doctor.
3. Don't stop taking medication on your own.
4. Don't crush or break pills.
5. Be clear about the drug's effects on driving and other daily tasks.
6. Learn about the drug's potential interactions with alcohol, other prescription medicines, and over-the-counter medicines.
7. Inform your doctor about your past history of substance abuse.
8. Don't use other people's prescription medications and don't share yours.

Controlled Substances

The Controlled Substances Act categorizes drugs and substances into one of five schedules based on their medical use, abuse and addiction potential, and harmfulness. Schedule I drugs have the highest abuse potential. Heroin falls into the Schedule I category, drugs that have no accepted medical use in the United States. Schedule II drugs include OxyContin, morphine, and Ritalin. Schedule III drugs include anabolic steroids and Tylenol (acetaminophen) with codeine.

Legitimate handlers of controlled substances, such as hospitals and pharmacies, have to register with the Drug Enforcement Administration and use their registration numbers to purchase drugs. They must maintain complete and accurate records of all quantities manufactured, purchased, and sold. Drugs with higher abuse potential are subject to more restrictions than other drugs. For example, registered handlers must use a special order form to obtain Schedule II drugs. And orders for these drugs must be written and signed by practitioners and not phoned into the pharmacy except in an emergency. Prescriptions for Schedule II drugs also may not be refilled; patients have to go back to the doctor first. Those convicted of unlawful manufacturing, distributing, and dispensing of controlled substances face fines, prison sentences, or both.

Most Commonly Abused

Opioids: Also known as narcotic analgesics. Used to treat pain, opioids are the most commonly abused prescription drugs. Examples include morphine, codeine, OxyContin (oxycodone), Vicodin (hydrocodone) and Demerol (meperidine). In the short term, these drugs block pain messages and cause drowsiness. A large single dose can cause severe respiratory depression and death. Long-term use leads to physical dependence and, in some cases, addiction.

Central nervous system depressants: Commonly used to treat anxiety, panic attacks, and sleep disorders. Examples are Nembutal (pentobarbital sodium), Valium (diazepam), and Xanax (alprazolam). They slow down normal brain function and can cause a sleepy, uncoordinated feeling in the beginning of treatment. Long-term use can lead to physical dependence and addiction.

Central nervous system stimulants: Commonly used to treat the sleeping disorder narcolepsy and attention-deficit/hyperactivity disorder. Examples include Ritalin (methylphenidate) and Dexedrine (dextroamphetamine). These drugs, which can be addictive, enhance brain activity and increase alertness and energy. They elevate blood pressure, heart rate, and respiration. Very high doses can lead to irregular heartbeat and high body temperature.

Tags: Medicine

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.