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Gemfibrozil Pregnancy and Breastfeeding Warnings

Gemfibrozil is also known as: Lopid

Gemfibrozil Pregnancy Warnings

Gemfibrozil has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of skeletal variations and anophthalmia. There are no controlled data in human pregnancy. Gemfibrozil should only be given during pregnancy when benefit outweighs risk.

Doses of gemfibrozil 0.6 to 2 times the human dose [based on body surface area (BSA)] prior to and throughout gestation resulted in dose-related decreases in conception rate and at high dose the incidence of stillborn was increased. A slight reduction in pup weight during lactation was also noted. When administered from day 15 of gestation through weaning a dose-related decrease in birth weight and suppression of growth during lactation occurred. Doses 1 to 3 times the human dose (BSA) given to female rabbits during organogenesis resulted in dose-related decreases in litter size and at high doses the incidence in parietal bone variation increased.

Gemfibrozil Breastfeeding Warnings

There are no data on the excretion of gemfibrozil into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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