Xanax, similar drugs carry the FDA’s most serious warning. More perils are being added
The FDA will require more cautions be included with the Boxed Warning that comes with benzodiazepines such as alprazolam (brand name: Xanax), lorazepam (Ativan) and clonazepam (Klonopin).
Wednesday’s announcement said the agency’s most serious warning, also called a Black Box Warning, now must “describe the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions consistently across all the medicines in the class.”
The Boxed Warning on benzodiazepines since 2016 focused mainly on combining the drugs, used to treat anxiety, seizures and social phobias, with opioids.
“Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death,” that warning reads.
The agency says U.S. pharmacies sold an estimated 92 million benzodiazepine prescriptions in 2019, the top three of alprazolam, clonazepam and lorazepam accounting for about 84% of that or 77,280,000. Half the people prescribed benzodiazepines in 2018 took them for two months or longer.
After reviewing various data on benzodiazepine usage and addiction, the agency concluded, “benzodiazepines are widely prescribed in the U.S., often for long periods of time. 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.”
But the FDA also interpreted the information as “benzodiazepine abuse and misuse are common and that associated harms are substantial but occur primarily when people use benzodiazepines in combination with other drugs.”
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