US FDA: warnings about risks of abuse, addiction for all benzodiazepines
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US FDA: warnings about risks of abuse, addiction for all benzodiazepines The US FDA is requiring the Boxed Warning be updated for all benzodiazepines to include warnings about the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions. In the Drug Safety Communication released 23 September 2020, the FDA notes that the current prescribing information for benzodiazepines does not provide adequate warnings about the serious risks and harms associated with these medicines. The FDA reviewed postmarketing databases, adverse-event reports and published literature on abuse, misuse, addiction, dependence and withdrawal associated with benzodiazepine use, noting that benzodiazepines are widely prescribed in the US, often for long periods of time. The data also suggest that benzodiazepine abuse and misuse are common, and the associated harms are substantial. Benzodiazepine abuse and misuse occur most commonly in combination with alcohol, prescription opioids and illicit drugs. The review also showed that serious withdrawal reactions can occur when benzodiazepines are discontinued suddenly or the dose is reduced too quickly. For all benzodiazepines, the FDA is requiring the Boxed Warning be updated accordingly and adding other information on the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions to the prescribing information. Several sections of the prescribing information, such as Warnings and Precautions, also need to be changed accordingly. In addition, the existing medication guides need to be updated to help educate patients and caregivers about these risks. FDA. FDA Drug Safety Communication: FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class - Includes potential for abuse, addiction, and other serious risks. FDA Drug Safety Newsletter : 23 Sep 2020. Available from: URL: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxedwarning-updated-improve-safe-use-benzodiazepine-drug-class 803506576
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Reactions 10 Oct 2020 No. 1825
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