Question to the Department of Health and Social Care:

To ask Her Majesty’s Government what assessment the Medicines and Healthcare Products Regulatory Agency and the Advisory Committee for Malaria Prevention have made of the United States Food and Drug Administration's Safety Communication of 29 July 2013 warning of the risk of psychiatric and nerve side effects from taking Lariam (mefloquine) as a malaria prophylactic.

Mefloquine (brand name Lariam) is one of several drugs licensed for the prevention (chemoprophylaxis) or treatment of malaria. As with any medicine, mefloquine may cause side effects in some people and the potential risks should be balanced against the expected benefits of therapy. Information on possible side effects is available to the medical profession via the Summary of Product Characteristics (SmPC), and to patients via the Patient Information Leaflet.

In 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) strengthened the warnings in the mefloquine SmPC, particularly regarding the well-established risk of neuropsychiatric side effects. The licence holder (Roche) also issued a letter to healthcare professionals at the end of October 2013 to increase awareness of these possible risks, alongside a prescriber checklist and patient alert card to aid compliance with the warnings. In November 2013, the MHRA issued a further communication to healthcare professionals on the risks of mefloquine via its Drug Safety Update bulletin:

www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON336723

As with all medicines, the MHRA will keep the safety of mefloquine under continual review.

The Advisory Committee for Malaria Prevention (ACMP) carefully considered all available data following the Food and Drug Administration’s safety communication and subsequent modification of the SmPC by Roche in September 2013. SmPC recommendations for monitoring of liver function and eye assessment in long term use have also been added to the guidelines. The ACMP continues to believe that mefloquine is a valuable option for prophylaxis against malaria when appropriate risk assessments are undertaken.