FDA now requiring boxed warning for benzodiazepines

The FDA is also requiring upgraded information on threats be contributed to benzodiazepines existing patient medication guides.

The companys press release stated about 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies in 2019, with alprazolam (typically prescribed under the brand name Xanax) and clonazepam (typically prescribed under the trademark name Klonopin) being given most typically.

Katie Adams –
Thursday, September 24th, 2020

The FDA is requiring the alerting info be updated for benzodiazepines, a class of common psychiatric drugs utilized to deal with generalized stress and anxiety condition, seizures, insomnia, social phobia and panic attack.

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The agency is mandating an upgrade to benzodiazepines boxed warning, the most major caution that can be put on a drug label. The labeling must consist of information on threats of misuse, addiction, physical dependence and withdrawal.

” While benzodiazepines are essential treatments for numerous Americans, they are also commonly abused and misused, frequently together with opioid painkiller and other medications, alcohol and illicit drugs,” FDA Commissioner Stephen Hahn, MD, said in a Sept. 23 news release. “We are taking procedures and needing brand-new labeling info to assist healthcare professionals and patients much better understand that while benzodiazepines have lots of treatment advantages, they likewise bring with them an increased threat of abuse, misuse, addiction and reliance.”.