FDA APPROVES LABEL CHANGES FOR POTIGA AND VISION LOSS

Ohio Pharmaceutical Lawyer: Potiga Vision Loss

“On October 31, 2013, the FDA issued a drug safety communication informing the public that the Agency has approved changes to the drug label of the anti-seizure drug Potiga (active ingredient ezogabine), underscoring risks of abnormalities to the retina in the eye, potential vision impairment, and skin discoloration, all of which may become permanent.”

Black Box Warning for Potiga

The Federal Drug Administration has now released an announcement stating GlaxoSmithKline Plc (GSK)’s anti-seizure drug, Potiga, must carry a black-box warning in the U.S.. regarding the drug’s potential to cause retinal abnormality and vision loss. The warning recommends that proscription of Potiga be limited to patients who have unsuccessfully attempted alternative therapies to decrease the occurrence of seizures or epilepsy.

In essence, the FDA is recommending that Potiga only be prescribed to patients for whom the “benefits outweigh the risks.” According to studies, those risks include retinal pigmentary abnormalities or vision changes, as well as discoloration of the skin, nail, mucous membrane, and white-of-the-eye. The FDA recommends patients taking Potiga have eye exams by an ophthalmic professional before starting Potiga and every six months during treatment.

 Potiga Vision Loss Lawsuit

The FDA increased the screening and instructions for use recommending that patients have eye exams by an ophthalmic professional before starting Potiga and every six months during treatment.

“If retinal pigmentary abnormalities or vision changes are detected, Potiga should be stopped unless no other suitable seizure treatment options are available and the benefits of treatment outweigh the potential risk of vision loss.”

Joe Lyon is a Cincinnati Catastrophic Injury Lawyer and Ohio Product Liability Attorney. If you or someone close to you is suffering as a result of a Potiga injury, please druginfo@fda.hhs.gov with questions and concerns or contact the Lyon Firm to learn about your options.