FDA requires new label warnings for opioid pain relievers
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The U.S. Food and Drug Administration is requiring new product label warnings for long-acting opioid pain relievers to combat prescription narcotic misuse, addiction and overdose deaths.
The labeling requirements are intended to educate prescribers and patients will apply to narcotic pain relievers such as OxyContin, a prescription drug often cited in studies as a significant driver of workers compensation costs.
Previous product labels said prescribing extended-release and long-acting opioid analgesics for moderate to severe pain. The updated language will say the drugs are for managing pain severe enough to require around-the-clock, long-term opioid treatment when 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 (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain,” the FDA said Tuesday in a statement.
The FDA also said it is requiring drug companies that manufacture long-lasting opioids to conduct more studies to further assess the risks of abuse, addiction and overdose deaths.
