The Food and Drug Administration (FDA) has announced new requirements for labeling opioid pain medications. The changes are aimed at improving patient awareness of the risks linked to long-term use of these drugs.
Under the new guidelines, labels for opioid analgesics must now include dosing warnings, a summary of study results that detail the estimated risks of addiction, misuse, and overdose with prolonged use, as well as treatment guidance. Labels will also need to provide reminders about how to safely discontinue use, information on overdose reversal agents, warnings about drug interactions, details on the risk of toxic leukoencephalopathy, and information regarding opioids' effects on the esophagus.
The FDA is also removing the phrase “extended treatment period” from labels. This change is intended to prevent patients and providers from misinterpreting this language as an indication that it is safe to take opioids over an indefinite timeframe.
More details can be found on the FDA website.
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