Baltimore City Health Commissioner Commends FDA for Issuing Warning for Dangerous Combination of Medications Amid Opioid Overdose Crisis

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BALTIMORE, MD (August 31, 2016) – Today, Baltimore City Health Commissioner Dr. Leana Wen issued the following statement in response to the decision by the U.S. Food and Drug Administration (FDA) to adopt a “black box warning” on the concurrent prescription of opioids and benzodiazepines: 

“I want to thank the FDA for taking swift action to answer our first-of-its-kind citizen’s petition by a coalition of City and State health officials. Doctors and public health leaders have spoken out about what we are seeing on the frontlines in our cities and states, and the FDA has changed its policies to help us protect the health and well-being of our communities. This is an incredible demonstration of how the FDA listens to citizens; how public health leadership matters; and how all of us can and do make a difference.

“As an emergency physician, I have seen that in medical training and practice, it is common to prescribe opioid painkillers to a patient taking benzodiazepines for anxiety, and vice versa. This is not based on scientific research, but is routine clinical practice.

“In recent years, we public health officials have noted an alarming trend: that nearly one in three unintentional overdose deaths from prescription opioids also involve benzodiazepines. We have also noted the growing biological evidence: that combining these medications increases sleepiness and slows breathing, increasing the likelihood of a fatal overdose.

“I wonder if any of the patients my colleagues and I treated suffered an overdose as a result of this deadly combination. Could we have saved lives if we knew of the potential dangers sooner? Could we have saved lives if we saw a “black box warning”—FDA’s strongest risk communication—that warned against this dangerous combination?

 “Today’s decision by the FDA is an important step that will help clinicians and patients prevent the potentially lethal interaction of opioids and benzodiazepines. I applaud the FDA for issuing this “black box warning” and for listening to the voices of public health leaders at the frontlines across the U.S. Much work is ahead of us. Together, we must get out this information to health professionals and patients to educate, change clinical practice, and stem the tide of the national overdose epidemic.”