The FDA Dilantin® Alert: What does it Mean for You?

Last year the Federal Food and Drug Administration came out with an alert for Dilantin® (phenytoin), one of the oldest and still most commonly prescribed anti-epileptic, anti-convulsion drugs.

There are a number of other drugs out there for epilepsy and seizure disorders (14 counted on WebMD alone), but the Stanford Hospital and Clinics website says that Dilantin® is the most popular for treatment of partial and secondarily generalized seizures in the United States.

A lot of epileptics and people with other seizure disorders take Dilantin®.

The side-effect being studied in relation to Dilantin® in this alert is an allergic skin reaction that goes by the name of Stevens Johnson Syndrome, or SJS. (TEN, Toxic Epidermal Necrolysis, is also considered to be part of SJS. The really bad part of SJS).

Here’s the Alert, verbatim from www.fda.gov:
FDA ALERT [11/24/08]: FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais.

OK, in plain english, what does this mean?

An allele is half of a genetic pair. The HLA-B*1502 allele is only present (with rare exception) in people of Asian ancestry. At this time it looks like there may be a link between the HLA-B*1502 allele and Stevens Johnson syndrome (SJS) and also Toxic Epidermal Necrolysis (TEN).

The FDA alert does not mean that SJS and TEN don’t occur in other populations; it means that if you are of Asian ancestry, and you do have this genetic marker, there appears to be heightened risk for a rare, life-threatening allergic disorder.

Maybe yes, maybe no…

The FDA Alert continues: The possible risk of SJS from phenytoin and fosphenytoin in patients with HLA-B*1502 is still being studied; however, there is not yet enough information to recommend testing for HLA-B *1502 in Asian patients for whom phenytoin treatment is contemplated.

The FDA point of view seems to be that’s there’s room to worry but nothing conclusive. The SJS/Dilantin® link is important enough to devote money to the study of the HLA-B*1502 allele, but not important enough at this time to mandate routine genetic tests for those taking Dilantin® who are of Asian descent.

The bottom line: if you take Dilantin®, there’s the risk of the Stevens Johnson Syndrome (SJS) side effect, whether you are of Asian descent or not. If you need representation, you’ve come to the right website!

The Mulligan Law Firm is a national law firm located in Dallas, Texas who provides information and resources for injured individuals and their families in all 50 states. The firm has successfully resolved over $600,000,000 in claims for its clients since 1995, and they are currently investigating injury claims involving Dilantin® and Stevens Johnson Syndrome (SJS).

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