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Piroxicam Pregnancy and Breastfeeding Warnings

Piroxicam is also known as: Feldene

Piroxicam Pregnancy Warnings

Avoid use in the third trimester; first and second trimester use only if the potential benefit outweighs the potential risk AU TGA pregnancy category: C US FDA pregnancy category: D (third trimester); C (first and second trimester) Comments: -Avoid use during the third trimester as it may cause premature closure of the ductus arteriosus. -This drug may be associated with a reversible delay in ovulation; use is not recommended for women who have difficulties conceiving or who are undergoing investigation of infertility.

Animal studies have revealed reduced weight gain, adhesions, peritonitis, hemorrhagic enteritis, gastric bleeding, and death in fetuses of rats at doses 5 times the maximum recommended human dose (MRHD), based on a mg/m2 body surface area. Additionally, pre- and post-implantation losses in animal studies have been shown. Administration of NSAIDs during the latter part of pregnancy may cause premature closure of the fetal ductus arteriosus and prolong 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. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. 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.

Piroxicam Breastfeeding Warnings

In 6 women receiving treatment for up to 52 days, drug concentrations in breast milk were found to be about 1% to 3% of the maternal concentration. A separate study in 4 women receiving 20 mg per day showed nursing infants would be expected to receive an estimated 3.5% to 6.3% of the weight adjusted maternal dose. In separate reporting, 5 older infants remained healthy when nursed by mothers receiving 20 mg once daily for at least 4 months. Due to lack of published clinical experience in newborns, shorter acting agents may be preferred.

UK: Use is not recommended AU and US: Use is not recommended unless potential benefits outweigh any potential risks. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.

References for breastfeeding information

  1. "Product Information. Feldene (piroxicam)." Pfizer US Pharmaceuticals, New York, NY.

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