The Food and Drug Administration said today that it will require tough new warnings on the labels of opioid painkillers, opioid-containing cough products and benzodiazepines in an effort to alert patients and doctors to the serious risks, including death, of combining the drugs.
The agency said it will require “boxed warnings” – its strongest category – as well as “medication guides” for nearly 400 products. The warnings will list the dangers of using the medications in tandem, which include extreme sleepiness, respiratory depression, coma and death.
“It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” FDA Commissioner Robert Califf said in a statement. “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or [central nervous system] depressants more generally – together outweigh these serious risks.”
The agency noted that the misuse of opiods, powerful pain medications that include prescription oxycodone, hydrocodone and morphine, has “increased significantly” in the United States over the past two decades. Benzodiazepines are prescribed for the treatment of anxiety, insomnia and seizure disorders. Both classes of drugs depress the central nervous system.
A data review by the agency found that doctors increasingly have been prescribing the different types of drugs together, with a resulting rise in “adverse outcomes.” From 2004 to 2011, the rate of emergency-department visits involving the non-medical use of both drug classes increased significantly. Overdose deaths involving both classes nearly tripled, the FDA said.
The FDA also found that the number of patients prescribed both an opioid and benzodiazepine increased by 41 percent between 2002 and 2014.
The Centers for Disease Control and Prevention warned doctors in the spring against prescribing opioids with benzodiazepines, except for patients battling diseases, such as cancer. But the CDC has no power to mandate changes.
(c) 2016, The Washington Post · Laurie McGinley