Final answer:
The black box warning for carbamazepine (tegretol) highlights the risk of potentially fatal skin reactions. It is the strictest warning given by the FDA and is included in the drug's prescribing information.
Step-by-step explanation:
The black box warning for carbamazepine (tegretol) is a safety alert mandated by the U.S. Food and Drug Administration (FDA) that is included in the drug's prescribing information.
It is the strictest warning the FDA can give for a drug and is used to highlight serious or life-threatening risks associated with its use.
In the case of carbamazepine, the black box warning is related to the risk of potentially fatal skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
These reactions can occur in anyone but are more common in people of Asian ancestry with a specific genetic marker called HLA-B*1502.
Patients taking carbamazepine should be educated about the signs and symptoms of skin reactions and instructed to immediately discontinue the medication if any occur.
Additionally, genetic testing for the HLA-B*1502 marker may be considered before starting carbamazepine to identify individuals at increased risk.