According to a recent report in The Lompoc Record, 17 year-old Gabrielle Corral was hospitalized in November after taking the medication, requiring intensive care after a painful rash developed behind her ears, on her lips and inside her mouth. Doctors diagnosed her condition as Stevens-Johnson Syndrome, which is commonly referred to as SJS.

For a time, the allergic reaction, which doctors believe was caused by GlaxoSmithKline’s Lamictal, left Corral in considerable pain, unable to see, speak or swallow. However, the teen is now out of the hospital and back in school after a number of surgeries to save her life and replace skin that was virtually burning from the inside out.

Stevens-Johnson Syndrome is a severe skin reaction that is known to occur as a side effect of several medications. It is highly debilitating and causes the skin to burn from the inside out, producing blisters, severe rashes and the skin may begin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis (TEN). Treatment in a hospital Intensive Care Unit (ICU) or Burn Unit is often required, and the conditions can be fatal in many cases.

Lamictal (lamotrigine) is approved by FDA for the treatment of epilepsy and bipolar disorder. GlaxoSmithKline, the manufacturer, has a “new warnings” alert on the their website for the drug, which leads to information about the potential risk of Stevens-Johnson Syndrome from Lamictal [PDF Medication Guide]. The warning indicates that signs of SJS are most likely to happen within the first two to eight weeks of Lamictal treatment. It also warns that children ages two to 16 are the most likely victims of Lamictal Stevens-Johnson Syndrome.

Corral required skin graphs which are still healing, lost 24 lbs. during her stay in intensive care and has to test which foods she can tolerate, but she returned to school at Lompoc High School and has rejoined her cheerleading squad. She is still healing and must wear sunglasses and heavy clothing to protect her skin while it heals.

About 2.7 million Americans have epilepsy, and the anti-seizure drugs generate sales of over $10 billion a year, making them the fifth best-selling class of medications in the United States.

FDA officials originally indicated earlier this year that the medications should carry a “black box” warning about the suicide side effects of the epilepsy drugs, which would be the strongest warning that can be placed on a prescription medication.

However, a panel of independent advisors to the FDA met in July 2008, and concluded that that a “black box” suicide warning was not appropriate.

In a statement released December 16, 2008, the FDA indicates that they have completed their analysis of data involving suicides and suicidal thoughts with the drugs used to treat epilepsy, psychiatric disorders and other conditions.

Based on their review, the FDA is requiring all manufacturers to add information about the risk of suicidal thoughts an actions to the Warning section of their labeling and to develop a Medication Guide which will be provided to patients receiving the drugs.

The 11 epilepsy drugs which will carry the new suicide warnings include: Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR); Felbamate (marketed as Felbatol); Gabapentin (marketed as Neurontin); Lamotrigine (marketed as Lamictal); Levetiracetam (marketed as Keppra); Oxcarbazepine (marketed as Trileptal); Pregabalin (marketed as Lyrica); Tiagabine (marketed as Gabitril); Topiramate (marketed as Topamax); Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon); and Zonisamide (marketed as Zonegran).

The FDA indicates that they have reviewed data from nearly 200 clinical trials, which indicate that those taking one of the epilepsy drugs are nearly twice as likely to experience suicidal behavior or thoughts when compared to those taking a placebo.

For every 500 patients treated with an antiepileptic drug, the FDA suggests that one additional suicide could be caused.

Healthcare providers have been asked to notify patients, their families and caregivers about the potential epilepsy drug suicide side effects, so that they can watch for unusual behavior or suicidal thoughts.