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'Black box' FDA warning urged for opioid and benzodiazepine combo

Public health officials are calling on the U.S. Food and Drug Administration to use its strongest safety warning for the risks of combining pain relievers with anti-anxiety medications, which they say is contributing to the sharp rise in overdose deaths.

The heads of 41 city and state health departments have signed a petition (PDF) submitted to the FDA Monday calling for the agency to include a “black box warning” label for opioids and benzodiazepines to inform the public on the risks of using the medications concurrently.

The effort is led by Baltimore City Health Commissioner Dr. Leana Wen and Dr. Nicole Alexander-Scott, director of the Rhode Island Department of Health. They urge healthcare providers not to wait for the FDA to take action.

“This is a national public health emergency,” Wen said. “Those of us who are frontline providers, we see the toll that overdose has in our jurisdictions, and we see the combined toll not only of opioid overdoses, but also of the overdoses due to the concurrent use of these two medications.”

Labeling for each types of medication would read: “WARNING: CONCURRENT USE WITH BENZODIAZEPINES/OPIODS REDUCES THE MARGIN OF SAFETY FOR RESPIRATORY DEPRESSION AND CONTRIBUTES TO THE RISK OF FATAL OVERDOSE, PARTICULARLY IN THE SETTING OF MISUSE.”

Studies have shown patients who take benzodiazepines are likely to be prescribed opioids for pain. Prescribing of benzodiazepines has increased as prescriptions of opioids have skyrocketed.

A recent study published in the American Journal of Public Health found the rate of overdose deaths from benzodiazepines rose by more than 400% between 1996 and 2010.

Alexander-Scott said benzodiazepine contributed to 17% of all opioid overdose deaths in 2006, and that figure had climbed to 30% by 2010.

Prescribers wrote 82.5 opioid prescriptions per 100 people and 37.6 benzodiazepine prescriptions per 100 people in the U.S. in 2010. Over the last decade, treatment admissions for co-occurring addiction to both opioids and benzodiazepines increased by 569%.

Wen and Alexander-Scott said doctors should look for alternatives to treating both chronic pain and anxiety for patients.

Opioid use has received much of the attention in recent years as the country has seen a stark rise in drug overdose deaths from prescription pain relievers and from heroin, which a growing number of Americans have switched to because it's cheaper and easier to get.


Steven Ross Johnson

Steven Ross Johnson joined Modern Healthcare's reporting staff in 2013 and covers the pharmaceutical and medical device industries and physician issues. Johnson has been a freelance reporter for the Chicago Tribune, Progress Illinois, the Chicago Reporter and the Times of Northwest Indiana and a government affairs reporter for the Courier-News in Elgin, Ill. He received a bachelor's degree in communications from Columbia College in Chicago and a master’s degree in journalism from the Medill School of Journalism at Northwestern University.

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