Malaria drug must now carry black box warning, FDA says

The FDA on Monday updated the warning on the antimalarial treatment mefloquine hydrochloride, which is sold under brand names such as Mefliam, Mephaquin and Lariam. The drug's label must bear the black box warning because the treatment could cause psychiatric adverse events including depression, paranoia, confusion and anxiety, as well as neurologic side effects including tinnitus, loss of balance and dizziness, the agency said. "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 agency said in a statement.

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