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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:
- 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.
- Symptoms of these eye disorders include visual impairment and blurred vision.
- In some cases the patient recovered very slowly but there have also been reports of permanent after-effects.
- Lariam treatment may need to be stopped if there are signs of certain conditions (such as retinal disorders or optic nerve damage).
Information for consumers
If you are currently taking Lariam, or have taken it within the past few weeks, and experience any visual disturbance, including blurred vision, seek advice from a health professional.
For more information about Lariam, consumers can refer to the medicine's CMI.
As with all medicines, your doctor has weighed up the benefits of taking Lariam to prevent malaria against the potential risks from side-effects.
Information for health professionals
The sponsor, in consultation with the TGA, has written to a range of health professionals including GPs listed on the Travel Alliance website, the Royal Australian College of General Practitioners, the Australian College of Rural and Remote Medicine, ophthalmologists and other specialists to provide information regarding this issue.
The following new safety information has been added as a Precaution in the PI:
Any patient presenting with a visual disorder should be referred to the treating physician, as certain conditions (such as retinal disorders or optic neuropathy) may require stopping treatment with Lariam.
The post market adverse effects section of the PI has also been updated to include information on the frequency with which these visual disturbances occur. "Visual impairment" has been listed as a common adverse reaction with "Vision blurred, cataract, retinal disorders and optic neuropathy which may occur with latency during or after treatment" occurring with unknown frequency.
Health professionals are reminded that because of the long half-life of Lariam, adverse events, including visual disturbances, may occur or persist up to several weeks after discontinuation of the drug.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.