FDA Updating Labels of Long-acting Opioid Painkillers

The agency says because of the risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate.

Safety labeling changes are coming to all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain, with the U.S. Food and Drug Administration stressing the risks of overdoses and addiction. "The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities," FDA Commissioner Dr. Margaret A. Hamburg said Sept. 10. "Today's action demonstrates the FDA's resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain."

"The FDA's primary tool for informing prescribers about the approved uses of medications is the product labeling," said Dr. Douglas Throckmorton, deputy director for regulatory programs in FDA's Center for Drug Evaluation and Research. "These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate prescribing, monitoring, and patient counseling practices involving these drugs."

Also, the agency is requiring a new boxed warning on these painkillers to caution that chronic maternal use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening, and is notifying ER/LA opioid analgesic application holders of the need for changes to these sections of drug labeling: Dosage and Administration; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information, and the Medication Guide.

FDA recommends that these drugs be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate. It responded on Sept. 10 to two citizen petitions that sought indication changes for opioids, limits on maxium daily doses, and the withdrawal of OxyContin and Palladone.

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