The FDA is requiring safety labeling changes to all opioid painkillers, to better highlight the risks posed by using the drugs long-term.
The changes come after a public advisory committee meeting in May, which reviewed data from two recently completed observational studies that had been required by the agency. They showed serious risks for patients who use opioids over a long time period, such as misuse, addiction and overdose.
The labeling changes include estimated risks; dosing warnings; clarified duration limits; treatment guidance; safe discontinuation; overdose risks and overdose reversal; drug interactions; and digestive health impacts. Manufacturers have 30 days to submit their labeling updates for review.
“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” FDA Commissioner Marty Makary, M.D., said in an agency announcement. “This long-overdue labeling change is only part of what needs to be done—we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”
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Additionally, the FDA has required another prospective, randomized clinical trial to examine the benefits and risks of long-term opioid use.
The FDA recommends that providers discuss pain with the patient and understand how it impacts their quality of life. The assessment should include non-pharmaceutical treatments that address the root causes of the pain when possible. A multimodal approach to pain management is recommended.
When opioids are necessary, providers are advised to prescribe the lowest effective dose of an immediate-release opioid for the shortest period possible. Providers should discuss the associated risks of the drugs and opioid overdose reversal agents like naloxone and nalmefene. Many acute pain conditions, such as after surgical procedures or musculoskeletal injuries, require only a few days of an immediate-release opioid, the FDA said.
Healthcare professionals are also encouraged to report adverse events involving opioid pain drugs to the FDA MedWatch program to help the agency track safety issues.