Stevens Johnson Syndrome in Children

Please note that the following information is provided as a public service only. We are not taking these cases.

Today, the FDA is warning consumers that clobazam, an anti-seizure chemical, has been linked to cases of Stevens-Johnson syndrome (SJS) and toxic epidural necrolysis (TEN), severe skin reactions that can (and did) cause blindness and death.

Today, the FDA issued a warning about these skin reactions. Patients taking clobazam should immediately seek medical help if they develop a rash, blistering, peeling of the skin, sores in the mouth or hives.

The FDA has advised health officials to discontinue the use at the first sign of rash, unless it is clearly not drug related. Again, a dermatologist should be consulted before SJS and TEN are ruled out.

According to the FDA, Stevens-Johnson syndrome and toxic epidermal necrolysis can occur at any time during treatment; however, the greatest risk is in the first 8 weeks of treatment or when product use  is stopped and then restarted.

The FDA has identified 20 cases of SJS/TEN. Six of these cases occurred in the United States., and 5 of the 6 were children. All of these cases resulted in hospitalization.

The FDA has approved an updated drug label for Onfi that includes a Warnings and Precautions statement and an addition to the Medication Guide describing the risk of serious skin reactions, including SJS and TEN.

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Category: Product Liability
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