The FDA is mandating labeling changes for opioid pain medications to highlight the risks associated with their prolonged use.
In May, members of a public advisory committee examined data linking extended opioid use to risks including misuse, addiction and overdose, according to a July 31 news release from the agency.
The updated labeling will include clearer risk information, stronger dose warnings, revised guidance on treatment duration and enhanced details about overdose reversal agents.
In addition to the labeling changes, the FDA is requiring a prospective, randomized clinical trial to further evaluate the benefits and risks of long-term opioid use.
Drug manufacturers have 30 days to submit their updated labeling for FDA review, the release said.
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