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FDA revises boxed warnings for extended-release and long-acting opioid analgesics and postmarket study requirements.
FDA has announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) 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 in a press statement. “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 class-wide labeling changes, when final, will include new language to help health care professionals tailor prescribing decisions based on a patient’s individual needs. The updated indication states that ER/LA 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 are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
FDA also is requiring the drug companies that make these products to conduct further postmarket studies and clinical trials to further assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death.
In addition, FDA is notifying ER/LA 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, as well as a warning that chronic maternal use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS).