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FDA: Pain Medication to Get New Warning Label

Jul 25, 2001

The label of OxyContin (oxycodone), a widely abused prescription pain drug, will soon include a new set of warnings intended to decrease the odds that it will be inappropriately prescribed, misused or diverted for sale on the streets.

The US Food and Drug Administration (FDA) announced on Wednesday that along with the drug's manufacturer, Purdue Pharma, it has made several changes to the label. The changes include the addition of a ``black box'' warning aimed at preventing physicians from prescribing the drug to inappropriate patients and as a result, increasing the chances of diversion.

Black box warnings are the strongest type of warning that the agency can include on an FDA-approved product.

Oxycodone is a morphine-like substance that works by blocking the transmission of pain messages to the brain by attaching and blocking receptors called opioids in the spinal cord and brain. The drug is found in more than 40 prescription pain medications, but some formulations of OxyContin contain particularly high levels of the drug.

According to experts, the narcotic has exhibited a similar potential for addiction as that of morphine, which has a high potential for abuse.

The FDA action follows numerous reported cases of OxyContin diversion in several states, including overdose-related deaths.

The only FDA-approved use for OxyContin is the treatment of patients with moderate to severe pain, who are expected to need this pain medication for an extended period of time.

Along with the labeling changes, Purdue Pharma will send a ''dear doctor'' letter explaining the changes to physicians, pharmacists and other healthcare professionals, the FDA said.

Since all opioid-blocking medications are subject to abuse, misuse and diversion, the agency is also encouraging other manufacturers of these morphine-like substances to revise their drug labels as well, the FDA said.

However, the agency added, it would continue to recommend that appropriate pain control be provided to patients who are living with severe pain.

Officials from Purdue Pharma were not available for immediate comment.

But in previous statements, the company has said that it would be unfair and outrageous to people in severe pain if government officials were to simply limit distribution of the drug.

``The answer to stopping drug abuse and the diversion of pain medications is to support law enforcement officials and enhance drug education and rehabilitation programs,'' said Dr. J. David Haddox, the company's senior medical officer.

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