UPDATE 1-FDA raises concerns on seizure drug of Valeant, Glaxo

Fri Apr 26, 2013 6:22pm EDT
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April 26 (Reuters) - The U.S. Food and Drug Administration said the an anti-seizure drug developed by Valeant Pharmaceuticals Inc and co-marketed with GlaxoSmithKline Plc may cause eye and skin problems.

The U.S. health regulator warned that the drug, Potiga, may cause bluish skin predominantly around lips, fingers and toes and pigment changes in the retina, which may lead to loss of vision. ()

"All patients taking Potiga should have a baseline eye exam, followed by periodic eye exams," the FDA said in a statement.

The regulator said it was working with the drugmakers and evaluating available information, and added that it does not know whether the changes caused by Potiga are permanent.

"It is not yet known whether the retinal pigment changes caused by Potiga lead to visual impairment, although several patients have been reported to have impaired visual acuity," the FDA said.

The regulator said the skin discoloration was observed after four years of treatment with Potiga but it appeared sooner in some patients.

"The retinal abnormalities and skin discoloration ... have been reported only in patients who were originally enrolled in Potiga clinical trials, and who have generally taken the drug for a long period of time," FDA said in a release posted on its website on Friday.

A Glaxo spokeswoman said the company would revise the prescribing information for the drug and talk to the regulators.   Continued...