jueves, 24 de septiembre de 2020

FDA Requiring Labeling Changes for Benzodiazepines | FDA

FDA Requiring Labeling Changes for Benzodiazepines | FDA

Morning Rounds

Shraddha Chakradhar

Benzodiazepines to now carry FDA's most serious warning

The FDA is requiring manufacturers of benzodiazepines, a class of psychoactive drugs, to include a boxed warning about the drugs' risks for addition, misuse, and withdrawal reactions. A boxed warning is the FDA's most serious type of warning that could be placed on a drug label. The FDA shared that it had reviewed adverse events reported to the agency in addition to databases with information after these drugs — colloquially known as "benzos" — had been on the market. The drugs were often prescribed for long periods of time, the agency found, and were widely misused, especially with other substances including alcohol or prescription opioids. The FDA had previously warned against taking benzos with opioid or cough medications as well as against withholding opioid use disorder treatment for those taking benzos. 

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