FDA Requires Stronger Warning Labels for Benzodiazepines

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is ordering drug manufacturers to update warning labels for benzodiazepines to strongly caution patients and providers about the risk of abuse, addiction, dependence and withdrawal. The agency said current warning labels are inadequate about the risks associated with anti-anxiety medications such as Xanax and Valium, even when they are taken as prescribed.

Benzodiazepines are generally used to treat anxiety, insomnia, seizures and social phobia, and they were once commonly prescribed to chronic pain patients to reduce anxiety and help them sleep. In recent years, many pain patients were taken off the drugs because they are considered risky when taken with opioid medication.

“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,” said FDA Commissioner Stephen Hahn, MD. “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.”

In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed by U.S. pharmacies, with alprazolam (Xanax) being the most common, followed by clonazepam (Klonopin) and lorazepam (Ativan).

The FDA said it reviewed post-marketing databases and its Adverse Events Reporting System, and found that benzodiazepines were often prescribed for long periods. In 2018, about half of patients prescribed the drugs received them for two months or more, even though most benzodiazepines are only recommended for short-term use. Physical dependence can occur after taking benzodiazepines for several days or weeks, according to the FDA.

“They are also widely abused and misused, often together with alcohol, prescription opioids, and illicit drugs, which worsen the risks of serious problems. We also found that some patients have had serious withdrawal reactions after benzodiazepines were stopped suddenly or the dose was reduced too quickly. Some patients experienced withdrawal symptoms lasting many months,” the agency said.

The FDA previously warned about the risks of combining benzodiazepines with opioids in 2016. Opioids and benzodiazepines are both central nervous system depressants that can cause sleepiness, respiratory depression, coma and death. In 2016, the number of emergency department visits due to non-medical use of benzodiazepines was higher than the number of ER visits for non-medical use of prescription opioids.

Fatal overdoses involving benzodiazepines increased from 1,298 deaths in 2010 to 11,537 deaths in 2017. The vast majority of those overdoses also involved other substances.