Post-marketing surveillance of prophylactic mefloquine (Lariam) use in pregnancy.

Abstract

The purpose of this study was to evaluate the teratogenic potential of mefloquine (Lariam) in pregnancy, based on the Roche International Spontaneous Reporting System. Lariam is an anti-malarial drug used both in prophylaxis and treatment of malaria. Teratogenic effects were observed in animals but data from humans are lacking. Women of childbearing potential are currently advised to take contraceptive precautions up to three months after the last dose. The study included 1,627 spontaneous reports of women exposed to Lariam before or during pregnancy, which were received by Roche worldwide since introduction on the market. The data were analyzed considering pregnancy and fetal outcome and type of congenital malformations. The birth prevalence of congenital malformations in women exposed to Lariam is estimated to be 4% and is not different from the prevalence observed in the general population. In addition, the congenital malformations observed with Lariam exposure do not show any specific pattern. The data from our study suggest that the teratogenicity, which was observed in animals at high doses, cannot be applied to humans.

Intermittent Treatment for the Prevention of Malaria during Pregnancy in Benin: A Randomized, Open‐Label Equivalence Trial Comparing Sulfadoxine‐Pyrimethamine with Mefloquine

“…However, the sample size was sufficient to detect a 70% increased risk of stillbirths in the MQ group, as was previously suggested in a study of Karen women treated with 25 mg/kg MQ [34]. This finding had not been reported in a larger prospective trial of MQ prophylaxis (250 mg per week) in Malawian pregnant women [35] or during postmarketing monitoring by the manufacturer of MQ [36,37]. Also, the proportion of congenital anomalies did not differ significantly between groups.…”

Intermittent preventive treatment for malaria in pregnancy in Africa: What's new, what's needed?

“…Mefloquine has been used alone for prophylaxis in the pre-conception period and in all trimesters of pregnancy[4,37-39,41,60] and used for the treatment of chloroquine and multidrug-resistant falciparum malaria in pregnancy, both as monotherapy[4,61-63] and in combination with other antimalarials, particularly artemisinins [64-66]. …”

Testing the cytotoxicity and genotoxicity of the antimalarial drug mefloquine

“…The teratogenicity of MQ has been previously demonstrated in animals at doses which are higher than the therapeutic doses that are recommended for humans (Zaneveld and Polakoski, 1977;Haward, 1996). In addition, Vanhaumere et al (1998) reported congenital malformations in children born to mothers who were on MQ therapy at different trimesters during pregnancy. This is an important consideration when prescribing treatment to women of childbearing age.…”