he Food and Drug Administration will now require its strongest warnings on the labels of certain prescription painkillers and anxiety medications, alerting doctors and patients about the risk of combining the drugs.
The new requirements for opioid analgesics (which include oxycodone and hydrocodone) and benzodiazepines follow a 41 percent increase in the number of patients prescribed both classes of drugs over the last decade and a resulting increase in overdose deaths in which they were used together. According to the FDA, such overdose deaths tripled from 2004 to 2011.
The agency is now requiring boxed warnings on the labels of opioids, explaining the danger of using the drugs in combination with benzodiazepines, and vice versa. Prescription opioid cough products will also be required to carry a warning about using them in combination with benzodiazepines.
“Boxed warnings highlight the need for change, the need for increased care,” said Dr. Doug Throckmorton, deputy director at the FDA’s Center for Drug Evaluation and Research, in a call with reporters. “We think that’s going to reset the conversation about the use of these products together.”
More than 80 million US patients were dispensed prescription opioids in 2014, and 30 million received benzodiazepines, which are used to treat anxiety, insomnia, and muscle spasms. According to the agency, nearly 1 in 3 unintentional overdose deaths involve these two classes of drugs being used in combination. Throckmorton also said that at least half of opioid and benzodiazepine prescriptions received by the same person are prescribed the same day by the same doctor.
The risks in using these drugs together has been known for some time, FDA officials said, but new data on the number of emergency room visits and deaths prompted the agency to make Wednesday’s announcement. The requirements will apply to 389 products, according to FDA Commissioner Dr. Robert Califf.
Dr. Leana Wen, Baltimore’s city health commissioner and one of the public health officials who pushed the FDA to require stronger warnings, told reporters that prescribing the two drugs together had become routine clinical practice, despite there being “no scientific reason” to do so.
Somebody who was in a car accident might be prescribed an opioid for the pain and a benzodiazepine for muscle spams. Or a patient taking a benzodiazepine for their anxiety might then be prescribed an opioid and their doctor wouldn’t necessarily ask if they were on anxiety medication, Wen said.
“There is no scientific reason why in medical training I was taught to prescribe benzodiazepines and opioids together. Like many other things, clinicians and doctors do things the way that we do because it is routine care,” Wen said. “This is something that’s happened over the years not because of malintent, not because of a desire to do something wrong by the medical profession.”
The FDA is also issuing more detailed guides for patients explaining the risks of combining opioids and benzodiazepines and a public notice to push that information out to the public.