Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department plans to review the (a) licensing and (b) prescribing guidelines for the anti-malarial drug Lariam.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses the available data, including from the Yellow Card scheme, and seeks advice from the Commission on Human Medicines, the MHRA’s independent advisory committee, where appropriate, to inform regulatory decisions, including amending the product information.

Mefloquine, commercially known as Lariam, is effective in the prevention and treatment of malaria and is licensed for use by the 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.

Patient safety is our top priority, and no medicine would be approved unless it met our expected standards of safety, quality, and effectiveness. Our role is to continually monitor the safety of medicines during their use, including Larium. We have robust, safety monitoring and surveillance systems in place for all healthcare products.  When a safety issue is confirmed, we always act promptly to inform patients and healthcare professionals and take appropriate steps to mitigate any identified risk.

As with any medicine, clinicians are responsible for making prescribing decisions for their patients, taking into account best prescribing practice and the local commissioning decisions of their respective integrated care board.

Clinicians 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. The national guidance for mefloquine is available at the following link:

https://cks.nice.org.uk/topics/malaria-prophylaxis/prescribing-information/mefloquine/

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.