(WDNews) In an effort to more clearly convey the grave dangers associated with long-term use, the U.S. Food and Drug Administration is requiring comprehensive safety label modifications for all opioid painkillers.
The ruling comes after an advisory committee meeting in May, during which data showed that patients who used opioids for prolonged periods of time faced numerous risks, including as addiction, abuse, and deadly overdoses. The increased hazards were confirmed by two significant FDA-mandated investigations.
The labeling change is a long-overdue but essential first step, according to FDA Commissioner Dr. Marty Makary, who referred to the epidemic as one of the public health establishment’s “cardinal failures.”
Stronger dosing warnings, more understandable risk wording, and updated guidelines on overdose reversal medications and drug interactions—including cautions about combining opioids with gabapentinoids—are some of the major modifications. In order to promote indefinite use, the label will also eliminate any potentially ambiguous terminology.
Manufacturers can submit revised labels for FDA review within 30 days. Additionally, a new clinical experiment is being conducted to better examine long-term opioid dangers.
Robert F. Kennedy, Jr., secretary of health and human services, hailed the action, saying it restores responsibility and honesty to a system that has long let patients and families down.
