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Dr. Alexander-Scott, Public Health Officials Urge FDA to Warn About Dangerous Combination of Medications Amid Prescription Overdose Crisis

Nicole Alexander-Scott, MD, MPH, Director of the Rhode Island Department of Health (RIDOH), co-led a group of health officials from throughout the country today in calling on the U.S. Food and Drug Administration (FDA) to adopt labels to explicitly warn about a dangerous combination of medications that is helping drive the nation's prescription drug overdose epidemic.

In a petition submitted to the FDA, the group called for a "black box warning" on opioids and benzodiazepines that states that concurrent use of the medications increases the risk of fatal overdose. Black box warnings appear on the labels of prescription drugs and call attention to serious or life-threatening risks.

Dr. Alexander-Scott was joined in signing the petition by health directors from 16 other states and territories and 13 cities, along with a collection of nationally renowned academics, researchers, and physicians. Leana S. Wen, MD, MSc, FAAEM., the Baltimore City Health Commissioner, spearheaded the national initiative, along with Dr. Alexander-Scott. A second petition, posted on Change.Org, can be signed by the public.

"Existing warnings about the concurrent use of opioids and benzodiazepines are inconsistent, infrequent, and insufficient. The FDA should act swiftly on the clear scientific evidence and add black box warnings to both classes of medication," said Dr. Alexander-Scott. "All of us?federal regulators, public health officials, and healthcare providers?have moral and professional obligations to make sure that people stop dying because of these drugs."

"This petition reflects Rhode Island's number-one priority as we address our drug overdose epidemic: saving lives," said Governor Gina M. Raimondo. "I commend Dr. Alexander-Scott's tremendous leadership in addressing this issue in Rhode Island and at the national level. If adopted, the black box warning will help drive down rates of drug overdose, which is hurting too many families in our state and across the country."

One of the four strategies of the Strategic Plan developed by Governor Raimondo's Overdose Prevention and Intervention Taskforce is to prevent overdoses through safer prescribing, particularly opioids and benzodiazepines. The goal of this Strategic Plan is to reduce opioid overdose deaths in Rhode Island by one-third within three years.

"The science is clear: combining opioids with benzodiazepines is dangerous and is fueling the overdose epidemic," said Dr. Wen. "A black box warning will help to educate both patients and clinicians about this potentially lethal drug interaction. By following our recommendations, the FDA can take an important step to reduce the toll of addiction and fatal overdose in communities across the country."

In addition to black box warnings, the petition calls for medication guides for both classes of medication to specifically warn patients about the risks of combined opioid and benzodiazepine use. Patients with chronic pain are often prescribed opioids to treat their pain and benzodiazepines to treat their associated symptoms, such as anxiety and sleep disorders.

In 2012, prescribers wrote 82.5 opioid prescriptions per 100 people and 37.6 benzodiazepine prescriptions per 100 people in the United States. Between 2000 and 2010, treatment admissions for co-occurring addiction to opioids and benzodiazepines increased by 569%. Evidence suggests that these two drugs interact in the brain and place patients at increased risk of respiratory depression and fatal overdose.

Every day in the United States, 44 people die as a result of prescription opioid overdose. In 2013, 22,767 people died of drug overdose deaths that involved prescription drugs. Approximately one in three unintentional overdose deaths from prescription opioids also involve benzodiazepines.

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