FDA Now Requires “Boxed Warning” Label for Benzodiazepines

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The U.S. Meals and Drug Administration (FDA) is requiring a “boxed warning” label for benzodiazepine medicines, such because the prescription drugs Ativan, Xanax, Klonopin, Librium and Valium.

The boxed warning, the company’s most prominent safety warning, will likely be required classwide for all benzodiazepines, the FDA introduced in its Drug Security Communication on Sept. 23.

The revised labels will state the dangers of abuse, misuse, habit, bodily dependence and withdrawal from benzodiazepines. The FDA has additionally revamped the warnings and precautions, drug abuse and dependence, and affected person counseling sections of the prescription data given to sufferers. As well as, the FDA has revised the prevailing treatment tips to teach sufferers and caregivers concerning the dangers.

Benzodiazepines work within the central nervous system to deal with a wide range of circumstances, comparable to anxiousness, panic dysfunction, seizures and sleep problems. Additionally it is used to deal with alcohol withdrawal and as a muscle relaxant.

Even when prescribed correctly, benzodiazepines are addictive. In 2019, outpatient pharmacies within the U.S. stuffed an estimated 92 million benzodiazepine prescriptions, in accordance the FDA press launch. Essentially the most continuously prescribed, at 38%, was alprazolam (or Xanax), which is used to deal with anxiousness problems and panic assaults. Twenty-four p.c of prescriptions have been for clonazepam (or Klonopin), which treats panic and seizure problems, sleeping points and alcohol withdrawal. Twenty p.c of prescriptions have been for lorazepam (or Ativan), used for anxiousness, insomnia, and alcohol withdrawal. Additionally it is given proper earlier than anesthesia.

“Whereas benzodiazepines are necessary therapies for a lot of People, they’re additionally generally abused and misused, usually along with opioid ache relievers and different medicines, alcohol and illicit medicine,” stated FDA Commissioner Stephen M. Hahn, MD.

“We’re taking measures and requiring new labeling data to assist well being care professionals and sufferers higher perceive that, whereas benzodiazepines have many therapies advantages, additionally they carry with them an elevated danger of abuse, misuse, habit and dependence.”

Benzodiazepine bodily dependency can happen if the medication is taken steadily for a number of days to weeks, in keeping with the FDA press launch. Sufferers who cease taking the treatment abruptly or scale back their dosage, might expertise signs of withdrawal, together with seizures, a few of which can be life threatening. The FDA advises sufferers to develop a plan with their physician to slowly taper off their treatment.