FDA Drug Safety Podcast: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects

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Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects

On July 29, 2013, the FDA issued a Drug Safety Communication advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label. FDA has revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the neurologic side effects may persist or become permanent. The neurologic side effects 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 drug use, and can last for months to years after the drug is stopped or can be permanent. Patients, caregivers, and health care professionals should watch 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 should be used. If a patient develops neurologic or psychiatric symptoms while on mefloquine, the patient should contact the prescribing health care professional.  The patient should not stop taking mefloquine before discussing symptoms with the health care professional.

Malaria is a serious disease caused by a parasite that commonly infects mosquitoes, which then bite humans.  It is a major cause of death worldwide but is less common in the United States. The disease is a problem primarily in developing countries with warm climates. Persons who travel to these countries may be at risk of malaria infection and should take drugs to prevent or reduce that risk. People with malaria often experience fever, chills, and flu-like symptoms. Drugs must be taken to treat the disease if you have been infected, but may, themselves, have side effects.

FDA will continue to evaluate the safety of mefloquine and will communicate with the public again if additional information becomes available.

At this time FDA recommends that Health Care Professionals be aware of the following:

  • Encourage your patients to contact you if they develop neurologic or psychiatric symptoms.
  • Make sure your patients receive the Medication Guide with every prescription.
  • Be alert to the potential for the development of neurologic and psychiatric adverse reactions in patients using the drug. If the patient develops psychiatric or neurologic symptoms during preventive use, mefloquine should be stopped and an alternate antimalarial medicine should be used.
  • Neurologic and psychiatric symptoms can be difficult to identify in children.
  • Report adverse reactions involving mefloquine to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, the complete Data Summary, and links to related information can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Info for up to the minute important drug information.  Know the moment it happens. 

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Page Last Updated: 10/20/2015
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