Other safety alerts
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| The United States: Potiga (ezogabine): Drug safety communication - FDA determines 2013 labeling adequate to manage risks of retinal abnormalities, potential vision loss, and skin discoloration |
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Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the FDA has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling. To further explore any potential long-term consequences of these pigment changes, FDA has required the Potiga manufacturer, GlaxoSmithKline, to conduct a long-term observational study.
FDA review of additional safety reports does not indicate that the pigment changes in the retina observed in some patients affect vision. Skin discoloration associated with the use of Potiga appears to be a cosmetic effect and does not appear to be associated with more serious adverse effects. Therefore, a modification of the Risk Evaluation and Mitigation Strategy (REMS) is not needed at this time to ensure that the benefits of Potiga outweigh the risks of retinal and skin pigment changes. FDA expects that the required long-term observational study will provide further information on whether pigment changes in the retina caused by Potiga can lead to vision loss or other long-term side effects. In addition, the study should provide more information on the relationship between pigment changes in the retina and skin discoloration.
Potiga is approved for use in combination with other anti-seizure drugs to treat partial-onset seizures in adult patients who have had an inadequate response to several alternative therapies and for whom the benefits of treatment outweigh the risks. The FDA advises health care professionals to follow the recommendations provided in the Boxed Warning, FDA’s most serious type of warning, and the Warnings and Precautions and Indications and Usage sections of the labeling.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm451181.htm
In Hong Kong, there are five registered pharmaceutical products containing retigabine (corresponds to the United States Adopted Name ezogabine). The products are Trobalt Film-coated Tablets 200mg (HK-61378), 400mg (HK-61379), 50mg (HK-61380), 100mg (HK-61381) and 300mg (HK-61382), and are prescription-only medicines registered by GlaxoSmithKline Ltd (GSK). Related news has been released by the US FDA and the EMA, and was posted on the Drug Office website on 27 April, 1 June and 2 November 2013. GSK has already updated the package insert of the products in February 2014 to include the relevant warnings on eye and skin disorders. So far, the Department of Health (DH) has not received any adverse drug reaction report on the drug. The DH will remain vigilant on any safety updates of the drug.
Ends/ Wednesday, June 17, 2015
Issued at HKT 13:00
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