FDA Revises Warning Labels On Certain Epilepsy Drugs

Armen Hareyan's picture

Certain Epilepsy Drugs

FDA on Wednesday announced revisions to the labelsof certain epilepsy, bipolar disorder and nerve pain medications to strengthenwarnings about potential risk for rare skin disorders and recommended thatpatients with Asian backgrounds undergo genetic tests before they take the treatments,the Wall Street Journal reports.

The revisions apply to:

  • Carbamazepine, the active ingredient in Carbatrol, manufactured by Shire;


  • Tegretol, manufactured by Novartis; and
  • Equetro, manufactured by Validus Pharmaceuticals.

The labels of themedications currently include warnings about potential risk for the skindisorders, which include toxic epidermal necrolysis and Stevens-Johnsonsyndrome. Under the revisions, the companies will place the warnings aboutpotential risk for the skin disorders, as well as the recommendation forpatients with Asian backgrounds, in black box warnings about potential risk foranemia currently included on the labels of the medications (Corbett Dooren, WallStreet Journal, 12/13).

According to FDA, about one to six per 1,000 patients who begin to take themedications will develop the skin disorders in nations with largely whitepopulations, with a 10% increase in risk in nations with largely Asianpopulations (CQ HealthBeat, 12/12). FDA said that studies havefound a link to the skin disorders and an inherited variant of HLA-B* 1502, agene found almost exclusively in individuals with Asian backgrounds.

In addition, FDA said that patients who have taken the medications for morethan a few months and have not developed the skin disorders likely will notdevelop them, regardless of background (Wall Street Journal,12/13).

"Patients currently taking carbamazepine who are concerned about theseskin reactions should not stop taking the drug without first consulting theirhealth care provider," FDA said (CQ HealthBeat, 12/12).

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