FDA Warns of Dilantin Stevens Johnson Syndrome (SJS)

In late 2007, the FDA demanded that drug companies change the labeling on the common epilepsy drug Dilantin. This change came from the revelation that the drug can cause serious, possibly life-threatening reactions in some patients. Specifically, it was found that Dilantin, sometimes known by the trade name of Phenytek, can cause Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

SJS and TEN

Both SJS and TEN are forms of a disorder called erythema multiforme. Lyell’s Syndrome is another name for these reactions. They are disorders causing hypersensitivity of the skin, and sometimes eyes and internal organs. In these disorders, lesions and blisters form on the skin. According to the National Institute of Health, these reactions can cause the following symptoms:

• Blisters
• Lesions
• Itchiness
• General feeling of illness
• Joint Pain

These symptoms can lead to much more serious complications. Complications can include bloodshot eyes, vision problems and eye irritation. The inflammation can also lead to permanent scarring on the skin and eyes.

Additionally, serious infections can result from SJS and TENS. Infections can occur in the skin (cellulitis) or the entire body (sepsis, also called “blood-poisoning”). The inflammation can even spread to major internal organs, including the heart, lungs, kidney and liver. Under the worst of circumstances, these complications can lead to the death of the patient.

SJS and TEN can result from a number of other medications and bacterial infections. However, Dilantin dramatically increases the risk of this reaction, particularly in susceptible individuals.

FDA Action

In December 2007, the FDA issued a warning to healthcare providers to advise patients of the increased risk of Stevens Johnson Syndrome and toxic epidermal necrolysis associated with Dilantin. The next year, the FDA mandated a change in labeling to reflect this risk. While the labeling was updated, damage was already done to many epilepsy patients who took Dilantin and then suffered from SJS and TENS.

Dilantin SJS Lawsuits

By the time that the alarm was sounded in late 2007, many epilepsy patients had already suffered grievous injuries from Dilantin. As a result, more than 100 lawsuits have been filed over these serious, life-threatening reactions to the medication. These lawsuits allege that the drug companies that marked Dilantin failed to warn patients about the potential for these potentially-lethal side effects. Drug companies have paid out millions of dollars to victims in various Stevens Johnson Syndrome settlements.  

If you or someone you know took Dilantin and went on to develop a serious allergic reaction like SJS or TEN, you may be eligible for compensation. To find out more, please go to the Dilantin Stevens Johnson (SJS) & Toxic Epidermal Necrolysis (TEN) Class Action Lawsuit Investigation. Using the form provided there, you can submit your information to receive a free legal review. If you have a case, an experienced SJS attorney will help you obtain a potential settlement for your injuries.