Anti-Seizure Drug ONFI Linked to Possible Fatal Skin Reactions

Onfi, the brand name of clobazam, is a medication used to treat epileptic seizures in children ages 2 through adults. This drug can cause serious skin reactions known as Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), according to reports and the U.S. Food and Drug Administration (FDA).

SJS is thought to be a milder form of TEN but its effects are so severe and something you would never suspect from taking a seizure drug. Both of these conditions are life-threatening skin conditions whereby the skin-cell death causes the top layer of skin, the epidermis, to separate from the inner layer of skin, the dermis.

The syndrome has been called a “hypersensitivity complex” which affects skin and mucous membranes. The condition starts in the immune system and eventually manifests itself in skin reactions. SJS usually starts with a fever, sore throat and fatigue and is commonly misdiagnosed and treated with antibiotics. As the condition progresses, painful ulcers and other lesions begin to appear, usually in the mouth and on the lips. The sores in the mouth are often so painful, the patient is unable to eat or drink. Recovery is similar to that of a burn victim.

The FDA ordered the drug manufacturer to add warnings about these skin reactions to their label in December 2013.

These serious skin reactions can occur any time during Onfi treatment. The likelihood of an adverse skin reaction is greater during the first eight weeks of treatment or when Onfi is stopped and re-started. Stopping Onfi suddenly can cause serious withdrawal problems, such as seizures, which will not stop, hallucinations, shaking, nervousness and muscle cramps. It is important to contact your health care provider before stopping any prescribed medications. All cases of SJS and TEN in the FDA case series resulted in hospitalizations; one of the cases resulted in blindness and one resulted in death.

Since the FDA announcement, the Onfi label has been revised to list information about the risk of serious skin reactions.

Feel free to contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878) for further information.

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