Pharmaceutical

Benzos label includes new black box warning regarding concomitant use with opioids

black box warning graphic WL Benzos label includes new black box warning regarding concomitant use with opioidsThe Food and Drug Administration (FDA) has approved the updated safety labels for all anti-anxiety drugs known as benzodiazepines to include a new boxed warning that use of benzos with the power painkiller opioids may result in “profound sedation, respiratory depression, coma, and death.” Similar warnings will also be added to opioids.

A black box warning is the strongest warning the FDA gives and is reserved for drugs and medical device to call attention to serious or life threatening risks.

Benzos, which include the brand names Xanax, Klonopin and Valium, are a class of psychoactive drugs that are used to treat anxiety, insomnia, agitation, seizures, muscle spasms, alcohol withdrawal and as a premedication for medical or dental procedures. The drugs work by depressing the central nervous system.

The boxed warning was required by the FDA following a review of studies that showed serious risks associated with combined use of benzos and opioids or other drugs that depress the central nervous system. Similar effects can occur when benzos are combined with alcohol.

The updated safety labels also include new information about these risks under Warnings & Precautions, and advises health care professionals to reserve concomitant prescribing of benzos and opioids for use in patients for whom alternative treatment options are inadequate, and to limit dosages and durations to the minimum required.

Sources:
FDA
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