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Celecoxib Pregnancy and Breastfeeding Warnings

Celecoxib is also known as: Celebrex

Celecoxib Pregnancy Warnings

Animal studies have revealed evidence of teratogenicity in rabbits and rats at doses approximately 2 to 6-fold human exposure, respectively, and pre- and post-implantation losses in rats at doses approximately 6-fold human exposure. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. Administration of NSAIDs during the latter part of pregnancy may cause premature closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation, and delay labor and delivery. There are no controlled data in human pregnancy. NSAIDs may delay or prevent rupture of ovarian follicles which has been associated with reversible infertility in some women. The withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility. 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. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

UK: Use is contraindicated unless an effective method of contraception is being used AU and US: Avoid use in the third trimester; first and second trimester, use only if the potential benefit outweighs potential risk AU TGA pregnancy category: B3 US FDA pregnancy category: C up to 30 weeks gestation US FDA pregnancy category: D from 30 weeks gestation and onward Comment: This drug should not be used starting at 30 weeks gestation as it may cause premature closure of the ductus arteriosus.

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Celecoxib Breastfeeding Warnings

AU and UK: Breastfeeding is not recommended US: Caution is recommended Excreted into human milk: Yes

Limited data has shown this drug is excreted into human milk in low levels. The averaged calculated daily dose in an exclusively breastfed infant is estimated to be 10 to 40 mcg/kg/day. In 2 breastfed infants (17 and 22 months of age) whose mothers were taking celecoxib 200 mg orally twice daily for many weeks, blood samples taken 4 hours after a maternal dose were undetectable (less than 10 mcg/L).

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References for pregnancy information

  1. "Product Information. Celebrex (celecoxib)." Searle, Chicago, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Celebrex (celecoxib)." Searle, Chicago, IL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

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