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Shezad Malik MD JD
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FDA Black Box Warning For Potiga Eye and Skin Problems

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The FDA has issued a black box warning against the anti seizure medication Potiga. Potiga is linked to eye damages and skin problem side effects.  On October 31, the FDA announced that GlaxoSmithKline, Potiga’s manufacturer is recommended to place a black box warning on Potiga.

1-Potiga Blindness AttorneyWhat is a Black Box Warning?

A Black Box Warning, is the strongest warning that can be placed on a prescription medication. The warning will alert patients and doctors to the risk of severe retinal pigment changes that can lead to blindness. The label will also warn about a risk of skin discoloration, particularly of hands, toes and lips, among users of Potiga.

The federal regulatory agency is recommending that doctors prescribe Potiga as a last line of drugs, only after safer drugs have been used and failed, and then only if the benefits outweigh the catastrophic side effects.

The FDA recommends that patients have eye exams by an eye specialist before starting the drug and every six months during treatment.

 

FDA Previous Potiga Warnings

The FDA first warned about the risk of Potiga eye and skin side effects in an April drug safety communication. The FDA had received several reports of blue skin discoloration on the lips, hands and feet.

There were also reports of changes in the color of the retinas of some patients, which can lead to blindness.

Blindness and Skin Discoloration Mechanism Unknown

According to the FDA, they do not know how long it takes for signs of abnormality to be detected, how fast the problem progresses, or if it is reversible after the patient stops taking Potiga.

The agency warns that if a patient’s vision cannot be regularly monitored, they should not be prescribed the drug. If pigment or vision changes are detected, the FDA recommends that patients be taken off Potiga.

Potiga Manufactured by Valeant Pharmaceuticals and GlaxoSmithKline

Potiga is manufactured by Valeant Pharmaceuticals in partnership with GlaxoSmithKline (GSK). Potiga is an anti-seizure medication that was approved in June 2011 for the treatment of partial-onset seizures in adults 18 years of age and older with epilepsy. Potiga is also sold by its generic name, ezogabine.