The Basics
What is Valdecoxib?
Used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms.
Brand names for Valdecoxib
Bextra
How Valdecoxib is classified
Analgesic Agents, Nonsteroidal Antiinflammatory Agents
Valdecoxib During Pregnancy
Valdecoxib pregnancy category
Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Valdecoxib while pregnant
The incidence of fetuses with skeletal anomalies such as semi-bipartite thoracic vertebra centra and fused sternebrae was slightly higher in rabbits at an oral dose of 40 mg/kg/day (equivalent to approximately 72-fold human exposures at 20 mg QD as measured by the AUC(0–24hr)) throughout organogenesis. Valdecoxib was not teratogenic in rabbits up to an oral dose of 10 mg/kg/day (equivalent to approximately 8-fold human exposures at 20 mg QD as measured by the AUC(0–24hr)). Valdecoxib was not teratogenic in rats up to an oral dose of 10 mg/kg/day (equivalent to approximately 19-fold human exposure at 20 mg QD as measured by the AUC(0–24hr)). There are no studies in pregnant women. However, valdecoxib crosses the placenta in rats and rabbits. BEXTRA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Taking Valdecoxib While Breastfeeding
What are recommendations for lactation if you're taking Valdecoxib?
Valdecoxib was removed from sale in the United States by the U.S. Food and Drug Administration because of long-term cardiovascular toxicity. Limited information indicates that levels of valdecoxib in breastmilk are low. Because there is little published experience with valdecoxib safety during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.
Maternal / infant drug levels
Valdecoxib was removed from sale in the United States by the U.S. Food and Drug Administration because of long-term cardiovascular toxicity. Limited information indicates that levels of valdecoxib in breastmilk are low. Because there is little published experience with valdecoxib safety during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.
Possible effects of Valdecoxib on milk supply
A study compared valdecoxib 20 mg and placebo for their opiate-sparing activity in post-cesarean section pain. All patients received epidural fentanyl and bupivacaine as well as intraspinal morphine for postoperative pain. No difference was observed in breastfeeding success rate between mothers who received valdecoxib (n = 25) and placebo (n = 23).[2]
Possible alternatives to Valdecoxib
Acetaminophen, Flurbiprofen, Ibuprofen, Indomethacin, Naproxen, Piroxicam.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Hale TW. Medications in breastfeeding mothers of preterm infants. Pediatr Ann. 2003;32(5):337-47. PMID: 12774709
2. Paech MJ, Salman S, Ilett KF et al. Transfer of parecoxib and its primary active metabolite valdecoxib via transitional breastmilk following intravenous parecoxib use after cesarean delivery: A comparison of naive pooled data analysis and nonlinear mixed-effects modeling. Anesth Analg. 2012;114:837-44. PMID: 22344242
3. Carvalho B, Chu L, Fuller A et al. Valdecoxib for postoperative pain management after cesarean delivery: a randomized, double-blind, placebo-controlled study. Anesth Analg. 2006;103:664-70. PMID: 16931678
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
