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Piroxicam Pregnancy and Breastfeeding Warnings

Piroxicam is also known as: Feldene

Piroxicam Pregnancy Warnings

Piroxicam has been assigned to pregnancy category C by the FDA. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided. In animal studies of piroxicam, gastrointestinal tract toxicity was increased in pregnant females in the last trimester of pregnancy compared to nonpregnant females or females in earlier trimesters of pregnancy. In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of piroxicam on labor and delivery in pregnant women are unknown. There are no adequate and well-controlled studies in pregnant women. Piroxicam is not recommended for use in pregnant women since safety has not been established in humans. Piroxicam should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

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Piroxicam Breastfeeding Warnings

Piroxicam is excreted into human milk. The presence in breast milk has been determined during initial and long-term conditions (52 days). Piroxicam appeared in breast milk at about 1% to 3% of the maternal concentration. No accumulation of piroxicam occurred in milk relative to that in plasma during treatment. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should made to discontinue nursing or discontinue piroxicam, taking into account the importance of the drug to the mother. However, Briggs et. al. has assigned piroxicam to risk factor C and states that in studies of nursing women, the concentration in human milk was approximately 1% of the serum levels of the mother and probably do not present a risk to the nursing infant. They state that piroxicam is probably compatible with nursing.

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References for pregnancy information

  1. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  2. "Product Information. Feldene (piroxicam)." Pfizer US Pharmaceuticals, New York, NY.

References for breastfeeding information

  1. Ostensen M "Piroxicam in human breast milk." Eur J Clin Pharmacol 25 (1983): 829-30
  2. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  3. "Product Information. Feldene (piroxicam)." Pfizer US Pharmaceuticals, New York, NY.
  4. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  5. Briggs GG, Freeman RK, Yaffe SJ. "Drugs in Pregnancy and Lactation. 8th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2008):
  6. Ostensen M, Matheson I, Laufen H "Piroxicam in breast milk after long-term treatment." Eur J Clin Pharmacol 35 (1988): 567-9

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