Other safety alerts
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| European Union: European Medicines Agency recommends restricting Trobalt (retigabine) to last-line therapy in partial epilepsy |
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The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended restricting the use of the anti-epileptic medicine Trobalt (retigabine) only to those patients for whom other anti-epileptic medicines have proved inadequate or have not been tolerated. This follows a careful evaluation of cases of pigmentation (abnormal colouring) of the skin, nails, lips and eye tissues, including the retina (the light sensitive layer at the back of the eye) reported in patients taking part in long-term studies.
The CHMP recommended that patients currently being treated with Trobalt should be reviewed at a routine (non-urgent) appointment. The balance of benefits and risks should be re-evaluated, and patients should be informed of the latest safety information. The CHMP also recommended that a comprehensive eye examination should be performed at the start of treatment (for new patients) and at least every six months during treatment. If retinal pigment or vision changes are detected, treatment with Trobalt should only be continued after a careful re-assessment of the balance of benefits and risks.
The CHMP considered not only the importance of retinal pigmentation, as it could possibly result in impaired vision, but also considered that uncontrolled epilepsy is a serious condition which may be life-threatening if left untreated. The CHMP therefore concluded that Trobalt remains a valuable alternative option for patients whose epilepsy cannot be controlled by other medicines.
Detailed recommendations for patients and healthcare professional are available at the link below.
http://www.ema.europa.eu/../news_detail_001802.jsp&mid=WC0b01ac058004d5c1
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. Similar safety information has been reported in Drug office’s website on 27 April, 2013. 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.
Related Information:
The United States: FDA Drug Safety Communication: Anti-seizure drug Potiga (Ezogabine) linked to retinal abnormalities and blue skin discoloration Posted 27-4-2013
Ends/Saturday, June 1, 2013
Issued at HKT 12:00
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