FDA to require warning on danger of opioid, benzodiazepine combination

A significant increase in emergency room visits during the last decade by patients taking both drugs spurred the agency to action.

By Stephen Feller

SILVER SPRING, Md., Aug. 31 (UPI) -- Based on increased reporting of adverse health effects from the combination opioid-based painkillers and benzodiazepines, the U.S. Food and Drug Administration is strengthening warnings against prescribing them together.

The FDA on Wednesday issued a new requirement for warnings on the boxes of more than 400 pharmaceutical products, as well as medication guides listing the potential for side effects and other health dangers from treating patients with opioids and benzodiazepines at the same time.


The two drugs are often prescribed together for patients with chronic pain conditions and depression, but the epidemic of opioid misuse and abuse has brought more attention not only to the painkillers themselves, but the potential for danger when used together.

In a review of medical data, the FDA reports the increase of emergency department visits for people using both drugs -- in many cases classifying their use as non-medical because of taking more than prescribed -- tripled from 2004 to 2011.

The agency is taking the action because, from 2002 to 2014, there has been a 41 percent increase in prescriptions of both drugs to single patients, equating to about 2.5 million more people potentially at risk for side effects or death.


The boxed warning, the FDA's strongest warning, and medication guides advise against combining the drugs for treatment based on the risk for extreme sleepiness, respiratory depression, coma and death.

The action by the FDA follows a U.S. Centers for Disease Control and Prevention report in March that warned of the effects of combining the drugs, including a reference to three studies of fatal opioid overdoses that found between 31 percent and 61 percent of patients had also been using benzodiazepines.

The warning is part of the FDA's Opioids Action Plan, spurred by public outcry for more warning and stronger restriction on how the painkillers are used with patients because of the huge increase in overdoses and abuse during the last two decades.

"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," Dr. Robert Califf, commissioner of the FDA, said in a press release. "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 CNS depressants more generally -- together outweigh these serious risks."


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