Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what guidance his Department gives to medical practitioners on the (a) risks of harmful long-term effects resulting from the prescription of Lariam (Mefloquine) as an anti-malarial prophylaxis and (b) treatment recommended for alleviation of such effects when experienced by people after being prescribed Lariam.

Mefloquine, commercially known as Lariam, is effective in the prevention and treatment of malaria and is licensed for use by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. The current product information for mefloquine states that neuropsychiatric adverse reactions may occur during treatment and includes warnings and precautions to minimise these risks. It also states that such adverse reactions may persist for months, or longer, even after discontinuation of the drug. It has not been established, however, that such adverse reactions may be permanent.

The UK was involved in the European Union’s safety review in 2013 which concluded there was a need for additional measures to strengthen the existing safety warnings for neuropsychiatric effects. A range of regulatory actions were implemented in Europe and the UK, including a letter to healthcare professionals highlighting the strengthened warnings about psychiatric effects in the product information for mefloquine, prescribing guides and checklists for healthcare professionals, and an alert card for patients. These documents are available at the following link:

https://www.medicines.org.uk/emc/product/9670/smpc

An article highlighting the new advice was also published in the MHRA’s Drug Safety Update newsletter, which is available at the following link:

https://www.gov.uk/drug-safety-update/mefloquine-strengthened-warnings-on-neuropsychiatric-side-effects

Subsequently, in 2014, the mefloquine product information was revised to warn that some psychiatric reactions may occur after discontinuation of mefloquine and may persist for some time after discontinuation. These updates were implemented across Europe including in the UK. Annual reminder letters highlighting the main risks associated with mefloquine and the patient checklist and alert card were issued until 2021 after which time it was agreed that due to low use of the product and a lack of enquiries for the risk minimisation materials annual letters were no longer required. The patient checklist and alert card remain available in the UK.

As with any medicine, clinicians are responsible for making prescribing decisions for their patients, considering best prescribing practice and the local commissioning decisions of their respective integrated care boards (ICBs). They are also expected to take account of appropriate national guidance on clinical effectiveness and safety, and are accountable for their prescribing decisions, both professionally and to their service commissioners. Prescribers are responsible for ensuring that any side effects experienced by their patients are addressed promptly; they should work with their patient to decide on the most suitable management plan, with the provision of the most clinically appropriate care for the individual always being the primary consideration.