,At Spine Pain Diagnostics Associates, we stay current on the latest FDA updates. We want our patients to be as educated as possible, so we often post helpful articles that will keep you up to date. Recently, the FDA announced that it is requiring class-wide changes to drug labeling for opioid medications, including opioid-containing cough suppressants and benzodiazepines, a class of central nervous system (CNS) depressant drugs.
The FDA is requiring boxed warnings—its strongest warning—and Medication Guides for 389 separate prescription opioid analgesics, opioid-containing cough medications, and benzodiazepines, which must include information about the serious risks associated with using these medications together, including extreme sleepiness, respiratory depression, coma, and death.
The FDA reviewed data about the use of these products and found that physicians have been increasingly prescribing opioids and benzodiazepines together, which has proven to be a lethal combination. In addition, from 2004 to 2011, the rate of emergency department visits involving nonmedical use of both drug classes increased significantly, with overdose deaths nearly tripling.
The labeling changes will affect both branded and generic products, according to FDA Commissioner Robert Califf, MD.
This action is one of several steps the FDA is taking as part of the agency’s Opioids Action Plan, which focuses on policies aimed at reversing the U.S. prescription opioid abuse epidemic, while still providing patients in pain access to appropriate pain treatments.
Opioid analgesics are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine, among other drugs. Certain other opioid medications are also approved to treat coughs.
Benzodiazepines are drugs typically prescribed for the treatment of neurologic and/or psychological conditions, including anxiety, insomnia, and seizure disorders. Both classes of drugs depress the central nervous system and, each has unique pharmacology, safety risks, and labeling information related to its use.
The FDA’s actions are consistent with the clinical guidelines released by the Centers for Disease Control and Prevention, and existing label warnings for prescribers regarding prescribing opioids and benzodiazepines to avoid potential serious health outcomes.
Adapted from: Pain Medicine News, FDA Requires Strong Warnings for Opioids and Benzodiazepines, Marie Rosenthal and Martin Leung. September 1, 2016. <http://www.painmedicinenews.com/Web-Only/Article/09-16/FDA-Requires-Strong-Warnings-for-Opioids-and-Benzodiazepines/37809>
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Angelie Singh, MD, MPH, MS