The FDA has approved label changes for mefloquine HCl, an antimalarial indicated for the prophylaxis of P. falciparum (including chloroquine-resistant strains) and P. vivax malaria; and for the treatment of mild-to-moderate acute malaria due to susceptible strains of P. falciparum or P. vivax.
The label changes include a boxed warning regarding serious neurologic and psychiatric effects. Neurologic effects can include dizziness, loss of balance, or ringing in the ears. Psychiatric side effect can include feeling anxious, mistrustful, depressed, or having hallucinations. Mefloquine should be stopped and an alternate antimalarial should be used if these symptoms develop during preventive use.
The FDA has also revised the patient Medication Guide to include the updated information and the possibility that the neurologic side effects may persist or become permanent.
Patients, caregivers, and healthcare professionals are to be alert to the potential development of neurologic and psychiatric adverse reactions in patients using the drug.
For more information visit FDA.gov.