American Family Physician
Copyright 2002 Gale Group Inc. All rights reserved. COPYRIGHT 2002 American
Academy of Family Physicians

Friday, November 15, 2002

ISSN: 0002-838X; Volume 66; Issue 10

FDA advisories.(Lariam, Lunelle)
Carrie Morantz; Brian Torrey

* Mefloquine. The U.S. Food and Drug Administration (FDA) announced that it and Roche have strengthened the contraindications, warnings, precautions, and adverse reactions sections of the product label for mefloquine hydrochloride (Lariam). Mefloquine is indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of Plasmodium falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax.

Mefloquine is also indicated for the prophylaxis of P. falciparum and P. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of P. falciparum.

Mefloquine 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.

The MedWatch 2002 safety summary is available online at www.fda. gov. The text of a letter sent by Roche to physicians, and the full, revised label are also available.