* 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.
* Lunelle. The FDA announced in October that Pharmacia is voluntarily recalling all Lunelle (medroxyprogesterone acetate and estradiol cypionate injectable suspension) prefilled syringe lots distributed in the United States, Puerto Rico, and the U.S. Virgin Islands during 2002, because of a lack of assurance of full potency and possible risk of contraceptive failure. A sub-potent dose of Lunelle may not be effective in preventing pregnancy. Lunelle packaged in vials is not affected by this recall, nor is any other Pharmacia contraceptive product.
Women who have been using Lunelle as their contraceptive are advised to seek the advice of their physician regarding alternative methods of birth control and to use an additional barrier method of birth control (such as male or female condoms, diaphragm, or spermicide) until beginning a new form of hormonal contraception.
Physicians may call the Pharmacia medical information service at 800-323-4204 for more information. Patients may call the Pharmacia patient information service at 888-691-6813.
COPYRIGHT 2002 American Academy of Family Physicians
COPYRIGHT 2002 Gale Group