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FDA Requires Opioid Label Changes

WASHINGTON — The Food and Drug Administration is requiring labeling changes to oxycodone and other extended-release and long-acting opioid analgesics, which may reduce the number of patients for whom these painkillers are appropriately prescribed.

FDA Commission Margaret Hamburg
Margaret Hamburg

“FDA has decided to change the labeling to help prescribers better understand the risks of prescribing extended-release long-acting opioid analgesics and to more clearly describe the patient population in whom these drugs should be used,” said FDA Commissioner Margaret Hamburg during a press conference, Tuesday.

These products are presently indicated “for relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment,” said Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. The new language will state that drugs are indicated “for the management of pain severe enough to require daily around the clock opioid treatment and for which alternative treatment options are inadequate.”


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“This focuses not simply on the pain intensity scale, but moves beyond it to focus on the patient, how they’re living and functioning and whether or not this modality of treatment is necessary to make that better, whether there are other things that can make it better and whether this is the right choice for the prescriber and patient to make,” Throckmorton said.

In addition to these changes, FDA is requiring that the box warning place greater emphasis on the risks of misuse, abuse, addiction, overdose and death.

“The box warning will describe that these drugs expose patients and other users to the risks of opioid addiction, abuse and misuse which can lead to overdose and death. It urges prescribers to assess each patient’s risk for abuse before prescribing and to monitor all patients regularly for the development of abuse,” Throckmorton said.

The FDA is mandating that the new boxed warning on these drugs caution that chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening. NOWS can occur in a newborn exposed to opioid drugs while in the mother’s womb.

SN Blog: National Database Would Limit Drug Abuse

Recognizing that more information is needed to assess the serious risks associated with long-term use of these drugs, the FDA is requiring the drug companies that make these products to conduct further studies and clinical trials. The objective of these studies are to further assess the known serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose, and death, according to the FDA.

Opioid prescriptions have increased by more than 300% between 1999 and 2010, and more than 2.4 million people were considered opioid abusers in 2010, according to one report.

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