There is no evidence that VERMOX® (mebendazole), even at high doses, is effective for hydatid disease. There have been rare reports of neutropenia and liver function elevations, including hepatitis, when VERMOX® is taken for prolonged periods and at dosages substantially above those recommended.

Carcinogenesis and Mutagenesis

In carcinogenicity tests of mebendazole in mice and rats, no carcinogenic effects were seen at doses as high as 40 mg/kg given daily over two years. Dominant lethal mutation tests in mice showed no mutagenicity at single doses as high as 640 mg/kg. Neither the spermatocyte test, the F₁ translocation test, nor the Ames test indicated mutagenic properties.

Impairment of Fertility

Doses up to 40 mg/kg in mice, given to males for 60 days and to females for 14 days prior to gestation, had no effect upon fetuses and offspring, though there was slight maternal toxicity.

Use in Pregnancy

Pregnancy Category C. Mebendazole has shown embryotoxic and teratogenic activity in pregnant rats at single oral doses as low as 10 mg/kg. In view of these findings the use of VERMOX® is not recommended in pregnant women. In humans, a post-marketing survey has been done of a limited number of women who inadvertently had consumed VERMOX® during the first trimester of pregnancy. The incidence of spontaneous abortion and malformation did not exceed that in the general population. In 170 deliveries on term, no teratogenic risk of VERMOX® was identified. During pregnancy, especially during the first trimester, VERMOX® should be used only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether VERMOX® is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VERMOX® is administered to a nursing woman.

Pediatric Use

The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/ risk should be considered.

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