News Releases

February 23, 2016

Vermont Health Commissioner Urges FDA to Issue Warnings for Dangerous Combination of Medications Amid Prescription Drug Overdose Crisis

Vermont Health Commissioner Harry Chen, MD joins city and state health directors from across 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, health directors and commissioners from 13 cities and 17 states and territories called for a "black box warning" on opioids and benzodiazepines that states that concurrent use of both 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.

"Warning prescribers and their patients about this dangerous combination of drugs is a duty of the FDA," said Dr. Chen. "Clear and consistent adoption of the black box warning just makes sense - it's one more action we can take to prevent opioid overdose deaths."

The lead signers of the petition were Baltimore City Health Commissioner Leana S. Wen, MD, MSc, FAAEM, and Nicole Alexander-Scott, MD, MPH, director of the Rhode Island Department of Health. A group of nationally renowned academics, researchers, and physicians also signed the petition.

"The science is clear: combining opioids with benzodiazepines is dangerous and is fueling the overdose epidemic," said Baltimore City Health Commissioner Dr. Leana 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."

"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."

A second petition, posted on Change.Org, can be signed by the public.

In addition to black box warnings, the petitions call 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 percent. 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.

City Health Commissioners who signed the petition:

* Baltimore: Leana Wen, M.D. MSc,

* Boston, MA: Monica Valdes Lupi, J.D., M.P.H.

* Chicago, IL: Julie Morita, M.D.,

* Dallas, TX: Zachary Thompson

* Denver, CO: Robert McDonald

* Detroit, MI: Abdul El-Sayed, M.D., DPhil

* Houston, TX: Stephen L. Williams, M.Ed., M.P.A.

* Long Beach, CA: Kelly Colopy

* Minneapolis, MN: Gretchen Musicant

* New York City, NY: Mary T. Bassett, M.D., M.P.H.

* Philadelphia, PA: Caroline C. Johnson, M.D., Acting Medical Director,

* Sacramento, CA: Olivia Kasirye, M.D., M.S.

* San Francisco, CA: Tomas J. Aragon, M.D., DrPH

State and Territorial Health Directors who signed the petition:

* Alaska: Jay C. Butler, MD

* Arizona: Cara Christ, MD, MS

* Arkansas: Nathaniel Smith, MD, MPH

* Connecticut: Raul Pino MD, MPH

* Delaware: Karyl Thomas Rattay MD, MS

* Guam: James W. Gillan, MS, HSA

* Maine: Kenneth Albert R.N., Esq.

* Maryland: Howard M. Haft, M.D.

* Massachusetts: Monica Bharel, MD, MPH

* Minnesota: Edward P. Ehlinger, MD, MSPH

* Montana: Richard H. Opper

* Pennsylvania: Karen M. Murphy, PhD RN

* Rhode Island: Nicole Alexander-Scott, MD, MPH

* South Carolina: Catherine Heigel

* Vermont: Harry Chen, MD

* West Virginia: Rahul Gupta, MD, MPH, FACP

* Commonwealth of the Northern Mariana Islands: Esther Muna, MHA, CPC

Proposed language for black box warnings

Labeling for all opioid class medications:

WARNING: CONCURRENT USE WITH BENZODIAZEPINES REDUCES THE MARGIN OF SAFETY FOR RESPIRATORY DEPRESSION AND CONTRIBUTES TO THE RISK OF FATAL OVERDOSE, PARTICULARLY IN THE SETTING OF MISUSE.

Labeling for all benzodiazepine class medications:

WARNING: CONCURRENT USE WITH OPIOIDS REDUCES THE MARGIN OF SAFETY FOR RESPIRATORY DEPRESSION AND CONTRIBUTES TO THE RISK OF FATAL OVERDOSE, PARTICULARLY IN THE SETTING OF MISUSE.

Resources online

* The full petition to the FDA: http://www.health.ri.gov/news/temp/2016FDAPetition.pdf

* The Change.org petition for the public to sign: https://www.change.org/p/u-s-food-and-drug-administration-fda-we-need-your-help-to-stop-overdose-death?recruiter491723466&utm_sourceshare_petition&utm_mediumcopylink

Media Contact: Communication Office, 802-863-7281

Source: Department of Health
Last Updated at: February 23, 2016 15:39:02