Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of the European Medicines Agency Pharmacovigilance Risk Assessment Committee’s 2014 report on the toxicity of mefloquine (Larium).
At its meeting in February 2014, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recommended that the product information for mefloquine (Lariam) be amended to state that neuropsychiatric adverse reactions may persist for months, or longer, even after discontinuation of the drug. The Medicines and Healthcare products Regulatory Agency (MHRA) accepted the recommendations and implemented the advice of the PRAC, which is reflected in the United Kingdom product information for mefloquine. In addition, the MHRA has since taken further action to ensure that these risks are adequately conveyed to UK prescribers and patients in the form of improved checklists for healthcare professionals and a patient alert card.