A class of drugs known as benzodiazepines, which includes the popular brand name drugs Xanax and Valium, must now carry a prominent boxed label warning about the risk that side effects may include long-term addiction and misuse.
The FDA issued a news release on September 23, announcing a new “black box” warnings for benzodiazepines. The agency is also recommending healthcare providers prescribing the medications limit the dosage needed to achieve the desired therapeutic effect and to be cautious of simultaneously prescribing of opioids.
Xanax, Valium and other “benzos” are designed to work on the brain’s neurotransmitters, causing sedative and hypnotic effects that are often used to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorders.
Officials estimate 92 million benzodiazepine prescriptions were dispensed in the United States in 2019, with Xanax being the most common, followed by Klonopin, lorazepam Intensol and Ativan.
Recent research suggests patients may become physically dependent on benzos, after only a few days of consecutive use, which could make the withdrawal period following stoppage potentially deadly. FDA officials warn stopping benzodiazepines abruptly or reducing dosage too quickly may cause acute withdrawal reactions, resulting in life-threatening seizures.
The FDA and National Institute on Drug Abuse have identified trends linking the use of benzodiazepine to the increased risk of using opioids, as well as a trend in overdose deaths involving the concurrent use of both medications. According to the research, more than 30% of overdoses involving opioids also involve benzodiazepines. The agency warns both drugs are designed to sedate users and suppress breathing, which can lead to an overdose death.
“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,” FDA Commissioner Stephen M. Hahn said in the press release. “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.”
As a result of the increased risks of overdose and dependency from side effects of Xanax and other medications in the class, the new FDA Boxed Warning for all benzodiazepines medications will now alert prescribers and patients to the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions.
As part of the FDA’s ongoing effort to minimize the risks of controlled substances, the agency has also issued changes to the to the Warnings and Precautions, Drug Abuse and Dependence and Patient Counseling Information sections of the prescribing information for all benzodiazepine products.
The FDA instructs healthcare professionals to consider a patient’s condition and assess their risk of abuse, misuse and addiction, and if necessary to limit the dosage and duration of each drug to the minimum needed to achieve the desired clinical effect.
Prescribing doctors are also being warned to take precautions and closely monitor patients issued benzodiazepines in conjunction with other addictive medications, such as opioids. Benzodiazepines patients should never abruptly stop taking the medications and should talk to their doctor about a gradual dosage decline plan to prevent withdrawal and possible life threatening seizures.
In 2016, the FDA issued a black box warning about co-prescribing benzos with opioids, indicating when taken together the risk of death greatly increases. Researchers indicated benzodiazepines, like Xanax and Klonopin are among the 10 most commonly prescribed psychotropic medications in the United States.
The heightened risk of benzodiazepine patients becoming addicted to opioids is a major concern among health officials, as the U.S. is currently still struggling with an opioid crisis. The U.S. Centers for Disease Control and Prevention (CDC) reports more than 70,000 drug overdose deaths occurred in the country in 2017, with 68% involving an opioid painkillers. Of those, 60% involved synthetic opioids like fentanyl.