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U.S. Department of Health and Human Services

Safety

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Lariam (mefloquine hydrochloride) October 2002

Audience: Infectious disease and other healthcare professionals

FDA and Roche strengthened the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the label. Healthcare professionals were notified that Lariam is contraindicated for prophylaxis in patients with active depression, a recent history of depression, generalized anxiety disorder, psychosis, schizophrenia or other major psychiatric disorders, or with a history of convulsions. During prophylactic use, if psychiatric symptoms such as acute anxiety, depression, restlessness or confusion occur, these may be considered prodromal to a more serious event. In these cases, the drug must be discontinued and an alternative medication should be substituted.

[September, 2002 - Letter to Physicians - Roche]
[September, 2002 - Letter to Pharmacists - Roche]