The Food and Drug Administration (FDA) recently decided to require so-called “black box warnings” on nearly 400 products, warning of the risks of combining certain opioid medications and central nervous system depressants called benzodiazepines.
Opioids are a class of powerful, pain-reducing medications that include oxycodone, fentanyl, and morphine. Certain prescription cough suppressants also contain opioids. Benzodiazepines, such as Xanax and Valium, are typically prescribed to treat neurological or psychological conditions such as anxiety, insomnia, and seizures. Both classes of drugs suppress the central nervous system and can cause drowsiness, dizziness, nausea, and slow or difficult breathing. Using these types of drugs together heightens those risks.
FDA’s new mandate comes after the Agency concluded that physicians increasingly prescribe both classes of drugs to the same patient, and that the rate of emergency room visits involving non-medical use of both drug classes had increased significantly from 2004 to 2011, with the rate of overdose involving both drug classes having tripled in that time.
While both opioids and benzodiazepines already carry warnings about the risks of combining the two types of drug, the new black box warnings are intended to catch the attention of the physicians and patients and underscore the seriousness of the threat.
The FDA’s mandate is one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan. This plan focuses on policies aimed at reversing a growing prescription opioid epidemic while continuing to allow patients to effectively manage their pain. Manufacturers of opioid and benzodiazepine undoubtedly are already in the process of revising their labeling, including patient information, to comply with the new mandate.
