Mibefradil Pregnancy and Breastfeeding Warnings

Brand names: Posicor

Mibefradil Pregnancy Warnings

Mibefradil has been assigned to pregnancy category C by the FDA. Animal data have revealed evidence of fetotoxicity (cardiovascular abnormalities) at doses up to 39 mg/kg/day (approximately 3 times the maximum recommended human dose [MRHD] on a mg per m2 basis). Skeletal abnormalities have been associated with the use of some other calcium channel blockers during pregnancy in animals. Mibefradil should only be given during pregnancy when benefit outweighs risk.

Animal data have shown that the use of mibefradil (13 mg/kg/day, or approximately the MRHD on a mg/m2 basis) was associated with prolonged pregnancy and/or dystocia, which were associated with uterine prolapse, stillbirths, and neonatal mortality. Other data have shown that the use of calcium channel blockers has been associated with decreased uterine contractions, presumably due to inhibition of calcium ions into the myometrium. In general, mibefradil should be avoided during the time of expected labor and during parturition.

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Mibefradil Breastfeeding Warnings

There are no data on the excretion of mibefradil into human milk.

Animal (rat) data have shown that mibefradil is concentrated in milk at levels of two to five times greater than corresponding serum levels. Extrapolating these data to humans, controlling for body weight differences, mibefradil would be expected to be excreted into human milk at levels just below maternal serum levels. Although animal lactation data are usually irrelevant, caution is recommended when a lactating woman is receiving mibefradil since (a) animal data suggest that this drug may be excreted into human milk, (b) the pharmacokinetic disposition of mibefradil is not known in newborn humans, and (c) other data have shown that human newborns may be more sensitive to the effects of calcium channel blockers compared with adult humans.

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Further information

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