Gemfibrozil Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Risk Summary: This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; adverse effects have been observed in rats and rabbits at doses between 0.5 and 3 times the expected human dose.
Comments: The physiological hyperlipidemia of pregnancy does not require treatment.
Female rats receiving 2 times the estimated human dose (based on body surface area) from before and throughout gestation showed a dose-related decrease in conception rate, an increase in stillborns, a slight reduction in pup weight during lactation, dose-related increased skeletal variations, and rarely anophthalmia. Female rats dosed with 0.6 to 2 times the estimated human dose from gestation day 15 through weaning showed dose-related decreases in birth weight and suppressions of pup growth during lactation. Reversible decreases in male fertility have been observed in reproductive toxicity studies in rats. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
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