FDA Orders Updated Warning Label for Clobazam
The U.S. Food and Drug Administration (FDA) has ordered that manufacturers of clobazam (Frisium, Urbanol and Onfi) update their product warning labels to reflect the risk of rare but deadly skin reactions.
Clobazam and Stevens-Johnson Syndrome
- According to Medscape, the FDA issued a warning that clobozam was linked to the serious skin reactions Stevens-Johnson syndrome and toxic epidermal necrolysis in December.
- The FDA was able to link 20 reports of Stevens-Johnson syndrome and toxic epidermal necrolysis to clobazam through its Adverse Event Reporting System (AERS) database.
- With about 31,000 patients having received clobazam since its approval in 2011, the agency was able to determine that as many as 6 in 10,000 users could develop these potential fatal skin conditions.
- Of the 20 cases, at least two resulted in death, one resulted in blindess and one involved a patient who had developed toxic epidermal necrolysis with clobazam monotherapy.
About the Skin Reactions
- Stevens-Johnson Syndrome and toxic epidermal necrolysis are potentially fatal skin reactions that result in cell death and the epidermis separating from the dermis.
- The condition is marked by flu-like symptoms followed by the development of a painfue red or purle rash that begins to spread across the body and blister.
- The reaction can take weeks or even months to treat, and can be fatal.
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