Also known as , Bextra, SC 65872
A sulfonamide derivative and non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic activities. Valdecoxib selectively binds to and inhibits cyclooxygenase (COX)-2, thereby preventing the conversion of arachidonic acid into prostaglandins, which are involved in the regulation of pain, inflammation, and fever. This NSAID does not inhibit COX-1 at therapeutic concentrations and therefore does not interfere with blood coagulation.
Originator: NCI Thesaurus | Source: The website of the National Cancer Institute (http://www.cancer.gov)
Can I take Valdecoxib while breastfeeding?
Valdecoxib was removed from sale in the United States by the US 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.
Drug levels
Maternal Levels. A review article states that breastmilk levels of valdecoxib are much less than 200 mcg/L based on unpublished studies from the author’s laboratory.[1]
Valdecoxib is the active metabolite that is rapidly formed from parecoxib. A single 40 mg dose of parecoxib was given intravenously to 40 mothers at an average of 41.9 hours after delivery. Four milk samples were collected over the next 24 hours. The average infant dosages in breastmilk were 0.24 mcg/kg daily for parecoxib and 1.82 mcg/kg daily for valdecoxib. This was equivalent to 0.63% of the weight-adjusted maternal dose in parecoxib equivalents, mostly excreted as valdecoxib. The half-life of valdecoxib in breastmilk was 8.5 hours.[2]
Infant Levels. Relevant published information was not found as of the revision date.
Effects in breastfed infants
Maternal Levels. A review article states that breastmilk levels of valdecoxib are much less than 200 mcg/L based on unpublished studies from the author’s laboratory.[1]
Valdecoxib is the active metabolite that is rapidly formed from parecoxib. A single 40 mg dose of parecoxib was given intravenously to 40 mothers at an average of 41.9 hours after delivery. Four milk samples were collected over the next 24 hours. The average infant dosages in breastmilk were 0.24 mcg/kg daily for parecoxib and 1.82 mcg/kg daily for valdecoxib. This was equivalent to 0.63% of the weight-adjusted maternal dose in parecoxib equivalents, mostly excreted as valdecoxib. The half-life of valdecoxib in breastmilk was 8.5 hours.[2]
Infant Levels. Relevant published information was not found as of the revision date.
Possible effects on lactation
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]
Alternate drugs to consider
Acetaminophen, Flurbiprofen, Ibuprofen, Indomethacin, Naproxen
References
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
Last Revision Date
20130907
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Source: LactMed – National Library of Medicine (NLM)