FDA Safety Alert: Stronger Warning for Mefloquine

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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The FDA recently ruled that the malaria drug mefloquine will now require a boxed safety warning on its labeling. A boxed warning or “black box warning” is the most serious warning regarding potential side effects.

Mefloquine is used for the treatment or prevention of malaria, a parasitic disease transmitted through mosquito bites. The CDC reports that on average there are 1500 cases of malaria in the United States each year, resulting in about 5 deaths a year.

The new boxed warning for mefloquine is due to some rare but severe side effects, with symptoms including:

According to the FDA’s safety evaluation the psychiatric symptoms “could persist for months or even years” and the physical symptoms “could become permanent.” However, although these are serious side effects, they are rare and the majority of patients tolerate mefloquine well. Mefloquine is still approved for use by the FDA and recommended as an option for malaria therapy.

While mefloquine is not a first line antimalarial drug (meaning there are other drugs that are more likely to be prescribed first), it still remains one of the most popular antimalarials prescribed. Mefloquine has some advantages: it can be used in patients of all ages, and is safe to use in pregnancy. It is also taken once weekly, which is useful for longer trips.

Mefloquine should be avoided if you have depression, seizures, schizophrenia, generalized anxiety disorder, or other psychiatric disorders.

If you or someone you know is traveling overseas, you may need to receive preventative therapy for malaria. Check out this map provided by the CDC, to see region-specific malaria risks.

Also, remember to always practice good habits that prevent mosquito bites. The CDC website provides strategies to prevent bites and specific recommendations on malaria for travelers.

Discuss your drug options for malaria prevention with your health care provider, as there are other antimalarial meds available. If mefloquine is an option, do a trial of the drug several weeks before your departure to evaluate your tolerance.

For more information, you can find the FDA announcement here, or talk to your doctor or pharmacist with any questions.

Till next week,

The GoodRx Pharmacist

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