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September 1, 2016

FDA requires 'black box' warnings for opioids, benzodiazepines

Daily Briefing

FDA on Wednesday announced new label requirements for prescription opioids and drugs called benzodiazepines to include so-called "black box" warnings detailing that the drugs can be fatal if taken together.

The black box warning is the strongest warning that FDA can issue.

Background on opioids, benzodiazepines

Benzodiazepine medications are most commonly prescribed to treat anxiety and mood disorders, such as depression and insomnia. The drugs also are used to treat seizures.

According to FDA, the number of individuals who were prescribed both opioids and benzodiazepines grew by 41 percent, or 2.5 million, between 2002 and 2014.

In February, 41 public health officials from across the United States submitted a petition to FDA calling for the agency to add black-box warnings about the potentially fatal combination of opioid painkillers and benzodiazepines to the drugs. The officials said prescription opioids and benzodiazepines often are used together, and data show that almost three in one unintentional overdose deaths from prescription opioids also involved benzodiazepines.

Black-box warnings to be added to almost 400 products

FDA said although prescription opioid and benzodiazepine labels often already include warnings about the potential effects of taking the drugs together, those warnings are insufficient. The agency said it hopes the new warning will get health care providers to better regard the notice.

The new requirement will affect 389 drugs, including all prescription opioids and benzodiazepines, as well as cough medicines that contain opioids.

The warnings will alert providers and consumers that taking opioid drugs in combination with benzodiazepines could result in coma, death, extreme sleepiness, and slowed breathing.

In addition to the new warning mandate, FDA also will require drugmakers to distribute pharmacy pamphlets to consumers that highlight the risks.

More than 200 opioid painkillers will receive FDA's 'black box' warning label

Further, FDA released guidance to help individuals taking both opioid drugs and benzodiazepines better understand the medications' potential risks. The guidance also urges health care providers to be cautious when prescribing the drugs together or changing the drugs' doses or dosing frequencies.


FDA Commissioner Robert Califf said, "It's 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." He added, "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 ... together outweigh these serious risks."     

Baltimore Health Commissioner Leana Wen said, "As an emergency physician, I have seen so many patients who are prescribed opioids and benzodiazepines together." Wen thanked FDA "for taking action to help prevent deaths from this dangerous combination," adding, "A black box warning is a powerful education tool."            

However, Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing, said he does not think black box "warnings have much of an impact." Instead, Kolodny said FDA should limit the way drugmakers are permitted to market opioids and place restrictions on opioid painkiller doses and prescription lengths (Clarke, Reuters, 8/31; Burton, Wall Street Journal, 8/31; Wheeler, The Hill, 8/31; Perrone, AP/Sacramento Bee, 8/31; Neel, "Shots," NPR, 8/31; McGinley, "To Your Health," Washington Post, 8/31; Tavernise, New York Times, 8/31).

How hospitals can reduce opioid prescriptions—and cut millions in costs

As legislators grapple with the opioid epidemic, hospitals are also rethinking their prescription practices. We polled over 200 acute care pharmacy leaders to understand how they are making formulary decisions, and what's the impact on reducing opioid prescriptions and related complications.

Read the research brief to learn more about our analysis of more than 400 organizations to investigate the impact of multi-modal pain regimens, and how your organization may be able to save over $1 million by reducing opioid use during surgery.

Download the brief

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