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Celecoxib Pregnancy and Breastfeeding Warnings

Celecoxib is also known as: Celebrex, Elyxyb

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.

US FDA Drug Safety Communication (10-2020): The FDA is requiring a new warning be added to NSAID labeling describing the risk of fetal kidney problems that may result in low amniotic fluid. The FDA is recommending pregnant women avoid NSAID use at 20 weeks gestation or later. Through 2017, the FDA has received 35 reports of low amniotic fluid levels or kidney problems in mothers who took NSAIDs while pregnant. Five newborns died; 2 had kidney failure and confirmed low amniotic fluid, 3 had kidney failure without confirmed low amniotic fluid. The low amniotic fluid started as early as 20 weeks of pregnancy. There were 11 reports of low amniotic fluid levels during pregnancy and the fluid volume returned to normal after the NSAID was stopped. The medical literature has reported low amniotic fluid levels with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. In other cases, the condition was reversible within 3 to 6 days of stopping the NSAID and in these cases reappeared when the same NSAID was restarted.

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.

Contraindicated last trimester of pregnancy
NSAIDs should be avoided at 20 weeks gestation and later

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

Risk Summary: Nonsteroidal anti-inflammatory drugs (NSAIDs) use in pregnant women at 30 weeks gestation and later may cause premature closure of the fetal ductus arteriosus; NSAID use at 20 weeks gestation or later may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Comments:
-NSAID use in pregnancy prior to 20 weeks gestation should be based on a benefit-risk assessment; some authorities recommend avoiding NSAIDs throughout pregnancy whenever possible.
-If NSAID use is necessary between 20- and 30-weeks' gestation, limit use to the lowest effective dose for the shortest duration possible; ultrasound monitoring of amniotic fluid should be considered if NSAID use extends beyond 48 hours; if oligohydramnios occurs, discontinue NSAID and treat appropriately.
-NSAID use is not recommended in women attempting to conceive as it may impair female fertility.

See references

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).

See references

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
  4. US Food and Drug Administration "FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. Available from: URL: https://www.fda.gov/media/142967/download." ([2020, Oct 15]):

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

Further information

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