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Gemfibrozil Pregnancy and Breastfeeding Warnings

Gemfibrozil is also known as: Lopid

Medically reviewed on September 25, 2017.

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: C

Animal studies have revealed evidence of adverse effects in rats and rabbits at doses between 0.5 and 3 times the human dose (based on body surface area), including dose-related decreases in conception rate, an increase in stillbirths, anophthalmia, parietal bone variations, and dose-related increases in skeletal variations. Administration from gestation day 15 through weaning also demonstrated decreases in birth weight and suppression of pup growth during lactation. Administration to male rats of about 2 times the human dose (based on body surface area) resulted in a dose-related decrease of fertility. This effect was reversed after an 8 week drug-free period and was not transmitted to offspring. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Gemfibrozil Breastfeeding Warnings

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-This drug should not be used while breastfeeding due to concern over disruption of infant lipid metabolism and the potential for tumorigenicity.

See references

References for pregnancy information

  1. "Product Information. Lopid (gemfibrozil)." Parke-Davis, Morris Plains, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Lopid (gemfibrozil)." Parke-Davis, Morris Plains, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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