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Boxed warnings to be required for opioids, benzodiazepines

The Washington Post (8/31, McGinley) reports that the Food and Drug Administration “will require tough new warnings on the labels” of opioid pain medications, cough syrups containing opioids, and benzodiazepines “in an effort to alert” patients and physicians “to the serious risks, including death, of combining the drugs.” The FDA will require boxed warnings and medication guides “for nearly 400 products,” listing “the dangers of using the medications in tandem, which include extreme sleepiness, respiratory depression, coma and death.”

The New York Times (8/31, B4, Tavernise, Subscription Publication) reports, “Experts said the new labels were good for raising awareness about the danger of taking both drugs, but were skeptical that they would change practices.”

Psychiatric News (8/31) reports, “Patients and health care professionals are encouraged to report any side effects involving opioids, benzodiazepines, or other medicines to the FDA MedWatch program.”

Additional coverage is provided by the Wall Street Journal (8/31, A3, Burton, Subscription Publication), the Los Angeles Times (8/31, Healy), Reuters (8/31, Clarke), NPR (8/31, Neel), CNN (8/31, Kounang), the Providence (RI) Journal (8/31, Arditi), the Washington Examiner (8/31, Takala), HealthDay (8/31, Thompson), and MedPage Today (8/31, Basen).


U.S. Food and Drug Administration Announcement

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