FDA Revises Mefloquine Labeling; Drug Still Recommended

Updated October 28, 2020

On July 29, 2013, the U.S. Food and Drug Administration (FDA) released a Drug Safety Communicationpdf iconexternal icon regarding revisions to the mefloquine label. FDA added a boxed warning indicating that they had received rare reports of neurologic side effects (dizziness, loss of balance, and ringing in the ears) that were permanent. However, FDA still approves of mefloquine for the prevention and treatment of malaria. Mefloquine is a very effective drug that is well tolerated by most people who take it.

There are, on average, 2,000 cases of malaria including 5 deaths reported every year in the United States, mostly in returned travelers. Cases of malaria among travelers can be prevented by taking certain medicines before, during, and after a trip to a country where malaria transmission occurs. Mefloquine is one of several options that can be used for the prevention and treatmentpdf icon of malaria. Mefloquine will remain an important component of CDC’s strategy to prevent malaria in travelers, especially those who are unable to take doxycycline and atovaquone-proguanil. For more information about malaria, check out the CDC malaria website.

Page last reviewed: October 28, 2020