New labels warn against mixing opioids, benzodiazepines

The Food and Drug Administration said Wednesday it will require stronger warnings on certain opioid medications and central nervous system depressant drugs among other labeling changes meant to reverse a nationwide opioid addiction epidemic.

Risks of combining the drugs include extreme sleepiness, respiratory depression, coma and death, the FDA said in a news release Wednesday. The review also found that these problems are becoming more prevalent.

Additionally, the number of patients who were prescribed both drugs increased by 41 percent between 2002 and 2014, an increase of more than 2.5 million patients receiving both opioid painkillers and benzos. Overdose deaths from taking prescribed or greater than prescribed doses involving both drug classes almost tripled during that period. Both classes of drugs depress the central nervous system (“CNS depressants”); however, each has unique pharmacology, safety risks, and labeling information related to its use.

Health professionals should avoid prescribing opioid pain or cough medications for patients taking benzodiazepines or using other CNS depressants, including alcohol. Warn patients and caregivers about the risks of slowed or hard breathing and/or sedation, and the associated signs and symptoms.

“If a patient was in a auto accident and experiencing neck pain, a clinician might prescribe opioids for the pain and benzodiazepines for muscle spasms”, she said. In their petition, health officers noted that almost one in three unintentional overdose deaths from prescription opioids also involve benzodiazepines. Dr. Califf called on doctors to “please heed these warnings” and to make them known in drug information given to patients. “It’s consistent with the larger work we are doing around opioids”.

While current drug labels and medical guidelines already caution against mixing the drugs, Wen said doctors still routinely prescribe them in combination. Those efforts were not enough.

FDA Commissioner Dr. Robert Califf has pledged to take a series of steps created to reduce prescription opioid abuse. “Communities have been seeing this trend for some time, but ultimately we needed data to act”.

According to FDA, the number of prescriptions for the two drugs increased significantly between 2004 and 2011, with the number of deaths involving both drugs almost tripling during that time.

On Wednesday, Baltimore City Health Commissioner Leana Wen thanked the FDA for its response, but asked if more lives could have been saved if the agency had acted sooner.

The move comes as prescriptions for both opioids and benzodiazepines has been increasing.