The Food and Drug Administration will now require more explicit warning levels on benzodiazepines.
The U.S. Food and Drug Administration (FDA) is demanding updated, stronger warnings be placed on benzodiazepines to blatantly display the “serious risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions” taking these drugs can cause. The agency is also calling for revisions to the patient medication guides. Benzodiazepines commonly prescribed to treat conditions such as anxiety, insomnia, alcohol withdrawal, muscle relaxation and seizure disorder, among other medical issues. Some of the most commonly prescribed benzodiazepines include Xanax, Klonopin and Ativan.
“The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately,” the FDA said.
FDA Commissioner Stephen M. Hahn, MD, added, “While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol, and illicit drugs. We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction, and dependence.”
According to the FDA, in 2019, an estimated “92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies, most commonly alprazolam, clonazepam, and lorazepam.” The year prior, about “5.4 million people in the United States aged 12 years and older abused or misused benzodiazepines.” What’s more, the National Survey on Drug Use and Health from 2015 to 2016 found around half million community-dwelling U.S. adults were estimated to have a benzodiazepine use disorder and overdose fatalities involving benzodiazepines increased from 1298 in 2010 to 11,537 in 2017, amid the opioid epidemic.
In 2016, the Centers for Disease Control and Prevention (CDC) issued new guidelines for the prescribing of opioids, which advised practitioners to avoid prescribing benzodiazepines alongside other opioids whenever possible. Both prescription opioids and benzodiazepines previously had FDA “black box” warnings, upon which the agency is expanding its requirements, making them stronger.
“Although the precise risk of benzodiazepine addiction remains unclear, population data clearly indicate that both primary benzodiazepine use disorders and polysubstance addiction involving benzodiazepines do occur,” the FDA said. “Before prescribing a benzodiazepine and during treatment, a patient’s risk for abuse, misuse, and addiction should be assessed.”
Opioid drugs are depressants and when taken in combination with other depressants, such as alcohol, the effects can be particularly deadly. The drugs alone can cause significant respiratory depression. Hahn said he was “concerned about widespread misuse of the drugs, especially when they are taken with opioid pain relievers, alcohol or other medicines.”
WebMd also warns these drugs have been used as “‘date rape’ drug(s) because they can markedly impair and even abolish functions that normally allow a person to resist or even want to resist sexual aggression or assault.”
The FDA suggests patients and caregivers be educated about the risks of abuse, misuse, addiction, dependence, and withdrawal with benzodiazepines and the associated signs and symptoms.