FDA Strengthens Black Box Warning on Lariam, a Drug Formerly Owned by Roche

Published: Aug 01, 2013

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The Food and Drug Administration announced on Monday that a commonly used anti-malaria drug must carry the so-called black box warning on its label because of the danger that the drug could cause serious neurological and psychiatric side effects, some of which can become permanent. The drug, mefloquine hydrochloride — better known by its brand name, Lariam — has long been known to cause side effects that include ringing in the ears, depression and hallucinations. The announcement on Monday clarified that some of the symptoms, like dizziness and loss of balance, could become permanent.

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