August 2, 2021

Regenstrief research scientist briefs FDA on use and misuse of benzodiazepines

The widespread nonmedical use — specifically abuse, misuse and addiction — of benzodiazepines , a class of psychoactive drugs which includes some of the most commonly prescribed medications in the United States, has become an issue of growing national concern.

Regenstrief Institute Research Scientist and Indiana University School of Medicine faculty member Kurt Kroenke, M.D., was invited to brief the U.S. Food and Drug Administration (FDA) on the current use and misuse of this class of drugs during “Safe Use of Benzodiazepines: Clinical, Regulatory, and Public Health Perspectives,” a July public meeting. He is the senior author of “Balancing the Risks and Benefits of Benzodiazepines,” a Viewpoint published earlier this year in the Journal  of the American Medical Association (JAMA).

Benzodiazepines are tranquilizers which induce a calming effect by making nerves in the brain less sensitive to stimulation. Members of this drug class are often prescribed for anxiety disorders, panic or social phobia. Anxiety disorders are the most common mental illness in the U.S., affecting an estimated 40 million adults.

“As with prescribing opioids for pain, the challenge for physicians in prescribing benzodiazepines for anxiety or other mental health disorders is to simultaneously consider and weigh the risks while selectively and cautiously using these potentially addictive drugs when clinically appropriate,” said Dr. Kroenke.

In 2018, nearly half of patients who filled an oral benzodiazepine prescription took the medication for two months or more. Prolonged benzodiazepine use may lead to abuse, dependence and tolerance, leading to misuse, dose escalations and withdrawal reactions.

In 2019, an estimated 92 million benzodiazepine prescriptions were filled in the U.S., according to the FDA.

Ominously, the risk of drug overdose deaths involving benzodiazepines is significantly increased when benzodiazepines are combined with other sedating drugs, most notably opioids. Between September 2016 and December 2017, almost 2 million benzodiazepines and opioids were co-prescribed.

“Patients often present with both pain and anxiety,” said Dr. Kroenke. “Treating symptoms is difficult, but these patients need appropriately prescribed relief.” Dr. Kroenke is an internationally respected pioneer in the field of symptomology and the co-developer of the GAD-7, the anxiety screening scale used by primary care physicians and mental health professionals around the globe.

New FDA prescribing guidelines advise physicians to (1) warn patients of the risks of benzodiazepines; (2) assess patients’ risk of abuse, misuse and addiction; (3) use caution when co-prescribing benzodiazepines with opioids; (4) seek the lowest effective dose for the shortest treatment duration possible and taper off benzodiazepines slowly; (5) consider alternate therapies; and follow up frequently with patients who are prescribed benzodiazepines.

While he believes fewer benzodiazepine prescriptions are warranted, Dr. Kroenke cautions that when considered without an appropriate patient-centered context, the new FDA prescribing guidelines may lead to fewer appropriate prescriptions and unintended consequences.

About Regenstrief Institute

Founded in 1969 in Indianapolis, the Regenstrief Institute is a local, national and global leader dedicated to a world where better information empowers people to end disease and realize true health. A key research partner to Indiana University, Regenstrief and its research scientists are responsible for a growing number of major healthcare innovations and studies. Examples range from the development of global health information technology standards that enable the use and interoperability of electronic health records to improving patient-physician communications, to creating models of care that inform practice and improve the lives of patients around the globe.

Sam Regenstrief, a nationally successful entrepreneur from Connersville, Indiana, founded the institute with the goal of making healthcare more efficient and accessible for everyone. His vision continues to guide the institute’s research mission.

About IU School of Medicine

IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.

About Kurt Kroenke, M.D., MACP

In addition to his role as a research scientist at Regenstrief Institute, Kurt Kroenke, M.D., MACP, is a professor of medicine at Indiana University School of Medicine and an IUPUI Chancellor’s professor.

  • Dr. Kurt Kroenke

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