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FDA Revises Mefloquine Labeling; Drug Still Recommended

On July 29, 2013, the U.S. Food and Drug Administration (FDA) released a Drug Safety Communication 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, 1,500 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 treatment 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.

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  • Health care providers needing assistance with diagnosis or management of suspected cases of malaria should call the CDC Malaria Hotline:
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  • Page last reviewed: August 2, 2013
  • Page last updated: August 2, 2013 The U.S. Government's Official Web PortalDepartment of Health and Human Services
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