ADR that result in revision of patient information
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| Australia: Safety advisory: Mefloquine hydrochloride (Lariam) - potential for visual disturbances |
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The Therapeutic Goods Administration (TGA) announced that the Product Information (PI) and Consumer Medicine Information (CMI) for the anti-malaria drug mefloquine hydrochloride (Lariam) have recently been updated to include new information about the potential for visual disturbances.
The new information was added following a review by the sponsor which included a cumulative review of available evidence from the company's non-clinical studies, the global drug safety database, the UK General Practice Research Database and the published literature.
To summarise the new information regarding visual disturbances:
1. Treatment with Lariam may be associated with an increased risk of eye disorders including cataract, retinal disorders and damage to the optic nerve. These may occur during treatment or for several weeks afterwards.
2. Symptoms of these eye disorders include visual impairment and blurred vision.
3. In some cases the patient recovered very slowly but there have also been reports of permanent after-effects.
4. Lariam treatment may need to be stopped if there are signs of certain conditions (such as retinal disorders or optic nerve damage).
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-mefloquine-hydrochloride-131011.htm
In Hong Kong, Lariam Tab 250mg (HK-36373) is registered by Roche and it is a prescription-only medicine. Regarding the issue, Roche informed the Department of Health (DH) and issued a Direct Healthcare Professional Communication (DHPC) on 16 July 2013 to alert healthcare professionals about the risk of eye disorders. Such information had been reported on the Drug Office website on the same day. Roche has submitted the application to change the package insert by including the relevant safety information. The application is currently under evaluation and being process. Related news has been released by HSA and was posted on the Drug Office website on 1 August 2013. The DH will keep vigilant on any safety updates of the drug.
Ends/ Friday, October 11, 2013
Issued at HKT 12:00
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