ADR that result in revision of patient information
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| The United States: FDA Drug Safety Communication: Anti-seizure drug Potiga (Ezogabine) linked to retinal abnormalities and blue skin discoloration |
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The U.S. Food and Drug Administration (FDA) is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. Potiga is approved as adjunctive (added on to other anti-seizure medications) treatment of partial-onset seizures in adult patients 18 years and older. The skin discoloration in the reported cases appeared as blue pigmentation, predominantly on or around the lips or in the nail beds of the fingers or toes, but more widespread involvement of the face and legs has also been reported. Scleral and conjunctival discoloration, on the white of the eye and inside eyelids, has been observed as well. The skin discoloration generally occurred after four years of treatment with Potiga, but has appeared sooner in some patients. In some cases, retinal abnormalities have been observed in the absence of skin discoloration. FDA does not currently know if these changes are reversible.
All patients taking Potiga should have a baseline eye exam and periodic eye exams that should include visual acuity testing and dilated fundus photography, and may include fluorescein angiograms (FA), ocular coherence tomography (OCT), perimetry, and electroretinograms (ERG). Patients who are taking Potiga and develop any changes in your vision or any discoloration of your skin, including of your lips and nail beds should contact their health care professional right away. Patients should not stop taking Potiga without talking to their health care professional. Stopping such treatment suddenly can cause serious and life-threatening medical problems such as recurrence of seizures. FDA is working with the manufacturer to gather and evaluate all available information to better understand these events. FDA will update the public when more information is available.
Please refer to the following website in US FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm349847.htm
In Hong Kong, there are 5 registered pharmaceutical products containing retigabine (International Nonproprietary Name), which corresponds to the United States Adopted Name, ezogabine. The five products are Trobalt Film-coated tablets 200mg (HK-61378), 400mg (HK-61379), 50mg (HK-61380), 100mg (HK-61381) and 300mg (HK-61382), which are registered by GlaxoSmithKline Ltd. and are prescription only medicines. In view of FDA’s recommendations, GlaxoSmithKline Ltd. has informed the Department of Health (DH) that they will issue a Dear Healthcare Professional Letter about the new safety information and submit application for approval to change the package inserts to include the relevant safety information. The DH will keep vigilance against any safety updates of the drug and actions taken by overseas regulatory authorities for consideration of any action deemed necessary.
Ends/Saturday, April 27, 2013
Issued at HKT 12:00
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