Life-Threatening Skin Reaction Linked to Clobazam
The U.S. Food and Drug Administration is requiring a label update for all forms of the anti-seizure drug clobazam following reports of severe skin reactions in patients.
Clobazam Linked to Severe Skin Reactions
- According to the MedPage Today, 20 patients worldwide have developed Steven-Johnson syndrome or toxic epidermal necrolysis after taking the drug.
- The reactions have resulted in one patient going blind and all 20 patients being hospitalized including five children in the U.S.
- Clobazam (brand names Frisium, Urbanol and Onfi) is used in the treatment of seizures associated with Lennox-Gastaut syndrome and is approved for use in adults and children as young as two.
- Labels will not be required to warn of the life-threatening skin reactions and advise that treatment with clobazam be stopped at the first sign of skin rash.
- Patients taking clobazam are urged to seek immediate medical attention should they notice hives, blisters or skin peeling.
About Steven-Johnson Syndrome
- Steven-Johnson syndrome is a potentially fatal condition that occurs when the skin and mucous membranes react severely to infection or medication.
- The condition is marked by flu-like symptoms followed by a painful red or purple rash. The rash then begins to spread and blister resulting in the top layer of skin dying and shedding.
- Death can occur in up to 15 percent of untreated cases.
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