The U.S. Food and Drug Administration (FDA) announced class-wide safety labeling changes and new postmarketing study requirements for all extended-release and long-acting opioid analgesics intended to treat pain.
“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,” said FDA Commissioner Margaret A. Hamburg, MD. “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.”
Given the serious risks of using extended-release and long-acting opioids, the class-wide labeling changes, when final, will include important new language to help health-care professionals tailor their prescribing decisions based on a patient’s individual needs.
The updated indication states that extended-release and long-acting opioids are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Extended release and long-acting opioid analgesics are not indicated for as-needed pain relief.
Further Studies Required to Assess Risks
Recognizing that more information is needed to assess the serious risks associated with long-term use of extended-release and long-acting opioids, the FDA is requiring the drug companies that make these products to conduct further studies and clinical trials. The goals of these postmarket requirements are to further assess the known serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death.
The FDA is also requiring a new boxed warning on extended-release and long-acting opioid analgesics to caution that chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening and require management according to protocols developed by neonatology experts.
In addition, the FDA is notifying extended-release and long-acting opioid analgesic application holders of the need for changes to the following sections of drug labeling: Dosage and Administration, Warnings and Precautions, Drug Interactions, Use in Specific Populations, Patient Counseling Information, and the Medication Guide.
Once the safety labeling changes are finalized, modifications will also be made to the Extended Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health-care professionals educational programs on how to safely prescribe these agents and to provide medication guides and patient counseling documents regarding the safe use, storage, and disposal of opioids. ■