Reining in Opioids

FDA Ramps Up Label Warnings on Opioids

The Food and Drug Administration's new label requirements for opioids stress the risk of abuse, addiction, overdose, and death.
By: | April 7, 2016

Immediate release opioids will now have warning labels similar to those on extended release/long-acting opioids. The Food and Drug Administration said its new required classwide safety labeling changes include a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death.

Dr. Janet Woodcock, director, FDA Center for Drug Evaluation and Research

Dr. Janet Woodcock, director, FDA Center for Drug Evaluation and Research

“The updated indication clarifies that because of these risks immediate release opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., non-opioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated,” the government agency said on its website.

“The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient.”

The labeling change is part of what the FDA says is its “overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.”

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The agency is also mandating updated labeling for all opioids about potentially harmful drug interactions with other medicines that can result in a central nervous system condition called serotonin, and about the potential effects of opioids on the endocrine system and decreased sex hormone levels.

The risks exist for the immediate release and extended release/long-acting opioids as well as methadone and buprenorphine, which are used to treat opioid addiction.

“The updated indication clarifies that because of these risks immediate release opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options are inadequate or not tolerated.” — Food and Drug Administration

The agency is also addressing the risks related to interactions between opioids and benzodiazepines, a recent concern for workers’ comp stakeholders. The FDA said it is “aware of and carefully reviewing” scientific evidence and will inform the public and providers once its review is finished.

“The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “We have been and will continue to evaluate all new data to ensure that labels of opioid drugs contain appropriate prescribing information about the benefits and risks of prescription opioids.”

Nancy Grover is the president of NMG Consulting and the Editor of Workers' Compensation Report, a publication of our parent company, LRP Publications. She can be reached at [email protected]

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The R&I Editorial Team can be reached at [email protected]