FDA Expands Warning Labels on Opioids & Sedatives

By Pat Anson, Editor

The U.S. Food and Drug Administration is expanding the warning labels on all opioids and benzodiazepines – a class of anti-anxiety sedative that includes Xanax – because of the serious risk of overdose and death when the drugs are used together.

The FDA’s “black box” warning labels – the FDA's strongest warning – involve nearly 400 opioid analgesics, opioid-containing cough products, benzodiazepines and other central nervous system (CNS) depressants.  The risks associated with using the drugs simultaneously are fairly well-established and include extreme sleepiness, respiratory depression, coma and death.

The agency said the move is one of a number of steps the FDA is taking as part of its Opioids Action Plan, which is focused on policies “aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management.”

"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, MD. "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."

In addition to benzodiazepines, other CNS depressants include sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and alcohol.

The new warning labels caution physicians to prescribe benzodiazepines or other CNS depressants “at the lowest effective dose” if a patient is already taking an opioid.  

The FDA said the number of patients who were prescribed both an opioid analgesic and benzodiazepine increased by 41 percent between 2002 and 2014, which translates to an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.

From 2004 to 2011, the rate of emergency department visits involving non-medical use of both drug classes increased significantly, with overdose deaths involving the drugs nearly tripling.

Recent guidelines by the Centers for Disease Control and Prevention also urge doctors to use caution when co-prescribing opioids and benzodiazepines.

The prescribing of opioid pain medication in the U.S. has actually been in decline for several years, but the number of overdoses blamed on opioids – both legal and illegal – continue to rise. One explanation for that is that the co-prescribing of opioids and sedatives has not changed.

According to a 2015 study, over a third of the patients prescribed opioids for chronic musculoskeletal pain were given a sedative. And patients with a history of psychiatric and substance abuse disorders were even more likely to be co-prescribed opioids and sedatives.

In February 2016, the FDA received a citizen petition from the city of Baltimore and over 40 public health officials asking the agency to strengthen warning labels for opioids, sedatives and depressants. The FDA said it was already reviewing data on the simultaneous use of the drugs, but today’s action was a response to that citizen petition.