FDA toughens warnings on opioid prescription labels

The FDA adds a 'black box' warning on opioid labels.

The U.S. Food and Drug Administration is requiring manufacturers to add new warnings on opioid labels so doctors and consumers better understand the potential for abuse, overdose and death.

The boxed warnings, also known as "black box" warnings, are the strongest the agency requires and will be added to common immediate-release medications such as oxycodone and morphine that are taken every four to six hours for pain. They say the prescriptions should only be given for intense pain and only when alternatives are inadequate.

Such warnings already are found on more potent extended release opioid medications.

The measure comes just after the U.S. Centers for Disease Control and Prevention announced new standards for prescribing opioids in an effort to curb the growing epidemic of abuse nationwide.

The move by FDA was praised by Dr. Leana Wen, Baltimore City health commissioner, and Van T. Mitchell, state health secretary, for informing prescribers and patients about the risks.

They had previously called for the warnings, as well as ones for the co-prescribing of opioids and benzodiazepines, sedatives used to treat anxiety and other disorders. Wen said together they cause more than a third of unintentional prescription opioid overdose deaths. The FDA said it was reviewing such a warning.


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