Mefloquine Gets Boxed Warning For Neurologic, Psychological Side Effects

Federal drug regulators have announced that a new black box warning will be added to the antimalarial drug mefloquine, warning that side effects may cause neurological problems that could become permanent in some cases.  

On July 29, a drug safety communication was issued by the FDA involving the malaria drug, which is sold under the brand names Lariam, Mephaquin and Mefliam.

The FDA announced that a new boxed warning will be added to the medications, which is the strongest label warning that the agency can require. The new warning will indicate that mefloquine side effects may include dizziness, loss of balance and ringing in the ears that could persist for months or become permanent, continuing even after a patient has stopped taking the drug.

The FDA also warned that the side effects of mefloquine can include psychological problems, such as anxiety, paranoia, and depression. It can also cause users to experience hallucinations.

Mefloquine was first approved by the FDA for the treatment of malaria in the 1970s and use was expanded to include prevention of malaria in 1989. A number of necessary safety trials were not been performed at that time, and were not performed until years later, when it was found that a high number of users were suffering adverse events. Originally developed by the Department of Defense, the U.S. military stopped using the medication in 2009.

“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,” the FDA warned in the drug safety communication. “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.”

The FDA advises patients to contact their health care provider if they are taking mefloquine and begin to experience:

• Dizziness
• Loss of balance
• Ringing in the ears
• Convulsions or seizures
• Insomnia
• Anxiety
• Feelings of mistrust
• Hallucinations
• Depression
• Confusion
• Uncharacteristic behavior