Recently, Onfi (clobazam) has been linked to several cases of Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). As a result, Onfi side effects lawsuits have been filed against Lundbeck LLC, the manufacturer of Onfi. Lundbeck is accused of failing to warn users and physicians about Onfi SJS and Onfi TEN.

Onfi is an anti-seizure medication used to treat Lennox-Gastaut syndrome, a severe form of epilepsy. It was approved by the U.S. Food and Drug Administration (FDA) in October 2011. Since then, more than 30,000 prescriptions have been given to patients, including children.

The FDA received reports of SJS from Onfi users, mostly from children. Onfi lawsuits claim that the drug caused the development of SJS and resulted in extreme repercussions such as blindess and death, in addition to the already painful SJS (or TEN) symptoms and side effects.

In December 2013, the FDA added Onfi to their list of SJS related drugs. The FDA then required Lundbeck to adapt the drug’s label to include potential Onfi side effects of SJS and TEN.

Steven Johnson Syndrome and Toxic Epidermal Necrolysis

SJS is a severe skin disorder. It begins with flu-like symptoms, a red or purplish rash and then continues to develop into severe blisters. The skin often peels away from the body, burning from the inside out. This leaves the patient exposed to secondary infections, sepsis, and even death.

SJS can also affect mucous membranes, found in the mouth, eyes, and genital areas. It is possible for SJS to spread to internal organs and to leave permanent scarring on the skin. It is an extremely painful condition and requires immediate hospitalization.

TEN is the more severe form of Stevens Johnson Syndrome. While SJS tends to cover 10 percent of the skin, TEN can cover p to 30-90 percent of the skin. TEN causes the blistering to become so severe that the skin peels off in larger patches and sheets. TEN patients are often treated in burn wards as the wounds left by TEN resemble burns. The dangers surrounding TEN are greater than those associated with SJS. With more skin exposed, the likelihood of secondary infections, sepsis, and death increases.

Most SJS cases are not fatal, but patients may continue to experience complications (scarring, blindness, and organ failure). TEN has a significantly higher mortality rate: 40 percent of TEN victims die from the disease.

While SJS and TEN are rare, they have the potential to be extremely dangerous. Experts have estimated that 300 cases of SJS are diagnosed yearly. These conditions are often caused by a reaction to a medication.

Onfi Side Effects Lawsuits

Onfi side effects lawsuits claim that Lundbeck knew about SJS and TEN risks before the FDA announcement but did not warn users about them. One Onfi lawsuit alleged that Lundbeck encouraged off-label use of Onfi, which led to the development of TEN in an 11-year-old boy.

Lundbeck has been faced with charges of failure to warn, off-label promotion, defective design and manufacturing, negligence, concealing information, and misrepresenting a product.