FDA warned that Potiga may cause bluish skin predominantly around lips, fingers and toes and pigment changes in the retina, which may lead to loss of vision.
GlaxoSmithKline spokeswoman Sarah Alspach said that the company informed clinical trial investigators and regulators including the FDA of a new adverse drug reaction which is discoloration of nails, lips and skin.
The FDA has advised that all the patients taking Potiga should have a baseline eye exam, followed by periodic eye exams.
In June 2011, Potiga was approved for the treatment of partial seizures, a type of seizure in people with epilepsy.