The FDA is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. A boxed warning has been added to the drug label.
Neurologic side effects associated with use of the drug can include dizziness, loss of balance, or ringing in the ears. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations. Neurologic side effects can occur at any time during use, and can last for months to years after the drug has been stopped, or can even be permanent.
Mefloquine hydrochloride is indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible P. falciparum and P. vivax, and prevention of malarial infections by P. falciparum (including chloroquine-resistant P. falciparum) and P. vivax.
Patients, caregivers, and healthcare professionals should lookout for these side effects. When using the drug to prevent malaria, if a patient develops neurologic or psychiatric symptoms, mefloquine should be stopped, and an alternate medicine sought. If a patient develops neurologic or psychiatric symptoms while on mefloquine, the patient should contact the prescribing healthcare provider. The patient should not stop taking mefloquine before discussing symptoms with the healthcare provider.