The FDA Now Requires Stronger Warning Labels for Opioid Drugs
The U.S. Food and Drug Administration on Wednesday strengthened warnings about the danger of combining opioid painkillers or cough medicines containing opioids with benzodiazepines, a common class of sedatives.
The agency is requiring that black box warnings, the strongest available, be added to nearly 400 products, alerting doctors and patients that combining opioids and benzodiazepines can cause extreme sleepiness, slowed breathing, coma, and death.
The agency said the move is part of a broad action plan to reduce the number of deaths from opioid painkiller abuse.
“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,” said FDA commissioner Robert Califf.
“We implore health care professionals to heed these new warnings,” he added.
Opioids include oxycodone, hydrocodone, fentanyl, and morphine, and are sold under such brand names as OxyContin, Percocet, Vicodin, and Actiq. Benzodiazepines include such drugs as alprazolam, clonazepam, and lorazepam, sold under the brands Xanax, Klonopin, and Ativan.
The move comes as prescriptions for both opioids and benzodiazepines has been increasing. Between 2004 and 2011 the number of patients who were prescribed an opioid and a benzodiazepine increased by 41 percent, the agency said, an increase of more than 2.5 million in opioid pain patients also receiving benzodiazepines.
The number of overdose deaths involving both classes of deaths nearly tripled over the same period, the FDA said.
Warnings about the interaction of both classes of drugs have been in existence for years, but are insufficient, the agency said. The current move strengthens them and “alerts all kinds of people who might otherwise have missed the message,” Califf said on a call with reporters.
The FDA’s action comes six months after city and state health directors, led by Baltimore City Health Commissioner Leana Wen, petitioned the FDA to require boxed warnings on the drugs.
Speaking on the call, Dr. Wen thanked the FDA for “acting so swiftly to our petition.”
Every day in the U.S., 44 people die as a result of prescription opioid overdoses. Wen said roughly one in three unintentional overdose deaths from opioids also involves benzodiazepines.
The reason, she said, is that prescribing opioids and benzodiazepines together has long been the medical norm. Over the years prescriptions of both have soared, resulting in the current epidemic.