A serious nightmare: psychiatric and neurologic adverse reactions to mefloquine are serious adverse reactions

Mefloquine (originally marketed as Lariam) is a neurotoxic quinoline derivative antimalarial drug that is known to cause serious and potentially lasting neuropsychiatric adverse reactions. Since 2013, drug regulators in several jurisdictions, including the United States, the United Kingdom, Ireland, and Canada, have required their mefloquine labels be updated to warn that when used for malaria prophylaxis the drug should be discontinued at the onset of neurologic or psychiatric symptoms. These recent changes to the international labeling serve to imply that psychiatric and neurologic reactions to mefloquine prophylaxis may be an early warning of an impending more serious reaction that may further jeopardize the patient with continued use of the drug. To prevent these more serious effects, these drug labels now warn that mefloquine should be discontinued and that patients seek immediate medical intervention to obtain an alternative antimalarial drug when psychiatric or neurologic symptoms occur. When used correctly for malaria prophylaxis as the updated labeling now directs, it is reasonable to expect that mefloquine will be discontinued, and an alternative drug substituted, in each patient who develops psychiatric or neurologic symptoms. This opinion discusses the implications of this updated labeling for the reporting of adverse reactions and for the continued use of the drug in malaria prophylaxis.