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Regulatory Focus™ > News Articles > 2020 > 9 > FDA updates benzodiazepine boxed warning

FDA updates benzodiazepine boxed warning

Posted 23 September 2020 | By Kari Oakes 

FDA updates benzodiazepine boxed warning

 
 
The US. Food and Drug Administration (FDA) is requiring that the boxed warning on benzodiazepines be updated to provide a uniform description of the risks associated with all medications in the class.
 
On 23 September 2020, FDA announced in a Drug Safety Communication that current prescribing information for benzodiazepines "does not provide adequate warnings about the serious risks and harms associated with these medicines, so they may be prescribed and used inappropriately.”
 
The new information, to be added to an updated boxed warning and to prescribing information for all benzodiazepine medicines, will provide a uniform method of describing the risks of misuse or abuse, as well as risks of addiction and the potential for withdrawal symptoms “consistently across all the medicines in the class,” according to FDA.
 
Within the prescribing information, the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections are required to be updated.
 
The agency took action after completing a literature review and looking at postmarketing data; reviewers also evaluated 104 benzodiazepine-related events reported to the FDA Adverse Event Reporting System (FAERS) from 1968 through the end of June 2019. These 104 cases, said the agency, represented a small subset of all benzodiazepine cases reported through FAERS, but they were a series that presented “the most descriptive reports of dependence or withdrawal.”
 
Serious adverse events including neurologic symptoms as well as cardiovascular and gastrointestinal effects were associated with benzodiazepine withdrawal, even when medicines were prescribed for therapeutic reasons, said FDA.
 
The agency also noted that most poison control center calls involving benzodiazepines also involve other substances such as prescription opioids and alcohol, and that overdose deaths with a benzodiazepine as one of the implicated substances increased almost 9-fold between 2010 and 2017.
 
Patient medication guides are also being updated, said FDA in announcing the changes.
 
 
FDA Drug Safety Communication
 
 
 

Tags: FDA, US

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