Other safety alerts
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| The United States: Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration |
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FDA approved changes to the drug label of the anti-seizure medication Potiga (Ezogabine), underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent. The revised label includes a new boxed warning, because of the risk of abnormalities to the retina. FDA advises that Potiga use be limited to patients who have not responded adequately to several alternative therapies to decrease the frequency of seizures, or epilepsy, and for whom the benefits of treatment outweigh the risks.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm349847.htm
In Hong Kong, there are 5 registered pharmaceutical products containing retigabine (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. Relevant safety information has been reported in Drug Office’s website on 27 April 2013 and 1 June 2013. GlaxoSmithKline Ltd. has issued a Dear Healthcare Professional Letter about the new safety information and submitted application for approval to change the package inserts to include the relevant safety information. The DH will keep vigilant against the updates of the drug and actions taken by overseas regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, November 2, 2013
Issued at HKT 12:45 |
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