Epilepsy drug could increase risk of Stevens-Johnson Syndrome
The FDA announced this week that they are strengthening the warnings about certain epilepsy drug side effects which could lead to severe skin reactions, especially for those with Asian ancestry. Carbamazepin, which is sold as a generic and under the brand names Carbatrol, Tegretol and Equetro, has been associated with an increased risk of developing Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN), which are life-threatening conditions.
>>INFORMATION: Stevens-Johnson Syndrome Lawsuits
Carbamazepin therapies are approved to treat epilepsy, as well as bipolar disorder and nerve pain. The drugs already carry a warning which applies to all patients about the rare but severe skin reactions. However, the new warnings will be featured more prominently on the label and include specific information about an increased risk for those with Asian ancestry.
Steven-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) cause the skin to literally burn from the inside out. The conditions could be caused by a side effect of several different medications, including the epilepsy drugs.
Symptoms of SJS and TENS include the development of skin blisters, rashes, lesions, fever and itching. Blisters could also develop in the mouth, eyes, nose or genitals. In many cases, individuals who experience the skin reaction require treatment in a hospital burn care unit, and the condition can be fatal in approximately 5% to 15% of the severe occurrences.
The information about the risk of Stevens-Johnson syndrome associated with Carbamazepine, Carbatrol, Equetro and Tegretol side effects will be moved to a “black box” warning which is more prominently displayed at the top of the labels. The warning will also indicate that individuals with an Asian ancestry should receive a genetic test before starting treatment.
While the Stevens Johnson Syndrome risk exists for all new users of the epilepsy drugs, among Asian populations the risk is estimated to be about 10 times higher. There is a strong association between the development of the skin reaction and an inherited variant gene, HLA-B* 1502, which is found in some people of Asian ancestry.
The presence of the gene can be identified by a blood test, so the FDA is recommending that doctors give patients with Asian ancestry a genetic test before starting treatment. According to the FDA, the following figures should be considered:
- Approximately 10-15% of individuals from China, Thailand, Malaysia, Indonesia, the Philippines and Taiwan may carry the gene
- Approximately 2% to 4% of individuals from South Asia, including India, could have the gene
- Less than 1% of individuals from Japan and Korea appear to carry the gene.
EPILEPSY DRUG STEVENS JOHNSON SYNDROME LAWSUITS
The Stevens Johnson Syndrome lawyers at Saiontz & Kirk, P.A. investigate potential lawsuits for any individuals who have been diagnosed with SJS or TENS. The epilepsy drugs marketed as generic carbamaepine, Carbatrol, Tegretol and Equetro have been directly associated with an increased risk of the serious skin reaction, and the manufacturers have failed to adequately warn about the problem, especially for those with Asian ancestry.
If you, a friend or family member have experienced symptoms of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis, request a free lawsuit consultation and claim evaluation.
