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Strengthened and updated warnings about the serious psychiatric and neurologic side effects that can be caused by the malaria drug mefloquine hydrochloride have been added to the drug's label, the U.S. Food and Drug Administration says.
The neurologic side effects can include dizziness, loss of balance or ringing in the ears. Psychiatric side effects can include feeling anxious, mistrustful, depressed or having hallucinations.
The neurologic side effects can occur at any time while taking the drug and can last for months to years after patients have stopped taking the drug, or can even be permanent, the FDA said.
The drug now carries a boxed warning, the most serious kind of caution. In addition, the medication guide and wallet card for the drug have been updated to include the new information.
Mefloquine hydrochloride is prescribed for mild to moderate acute malaria transmitted by certain types of mosquitoes and for the prevention of malaria infections caused by those mosquitoes. The drug was previously marketed under the brand name Lariam, but it is no longer marketed in the United States. However generic versions are available in the U.S.
Patients, caregivers and health care providers should watch for these side effects, the FDA said. If a patient develops neurologic or psychiatric symptoms, treatment with mefloquine hydrochloride should be stopped and another medicine should be used. Patients should not stop using the drug before consulting with a health care provider.
source : Malaria Drug Gets Stronger Warning Label
