Dietary Supplement
PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports describing the use of chondroitin in human pregnancy have been located. The animal data suggest low risk, but the absence of reported human pregnancy experience prevents an assessment of the risk to the embryo–fetus. Moreover, the lack of standardization prevents knowledge of the exact dose taken. The oral bioavailability depends on the molecular weight of the product used, and this may not be known from the product’s package insert or label. However, chondroitin is an endogenous substance widely found in human tissues, so the embryo–fetus must synthesize it during development. Therefore, the planned or inadvertent use of chondroitin during gestation does not appear to represent a clinically significant risk of embryo–fetal harm.
FETAL RISK SUMMARY
Chondroitin is a mucopolysaccharide that belongs to a class of very large molecules called glycosaminoglycans (1,2). It is isolated from natural sources, such as shark and bovine cartilage. There are no official standards to regulate its production in the United States, so the actual dose taken cannot be accurately determined. Endogenous chondroitin acts as the flexible connecting matrix (substrate) between protein filaments in cartilage that is found in most mammals. The substance can be found in human cartilage, bone, cornea, skin, and the arterial wall (3). Oral chondroitin, frequently in combination with glucosamine or manganese, is used in the treatment of osteoarthritis, ischemic heart disease, osteoporosis, hyperlipidemia, and other conditions. An IM formulation (not available in the United States) is used for osteoarthritis and topical chondroitin is used for dry eyes and as an adjunct to ocular surgery. With the possible exceptions of its use for osteoarthritis and dry eyes, studies are needed to confirm the efficacy of chondroitin. The oral bioavailability of oral chondroitin has been reported to be minimal, in the range of 0%–13% (1), but is thought to depend on the molecular weight of the chondroitin product studied (3).
Animal reproduction studies have been conducted in mice and rats, but the doses used were not related to the human daily dose in terms of BSA or AUC. Injection of 1 mL (20 mg) of a 2% solution of chondroitin sulfate into mice during organogenesis resulted in cleft palates or kinky tails (4). No adverse effects were observed with oral doses up to 5000 mg/kg of chondroitin polysulfate given to rats and mice during organogenesis (5).
It is not known if chondroitin crosses the animal or human placenta. The molecular weight (5000–50,000) and probable very low blood concentrations suggest that minimal amounts, if any, will cross to the embryo or fetus.
BREASTFEEDING SUMMARY
No reports describing the use of chondroitin during lactation have been located. Depending on the source, the molecular weight (5000–50,000) and probable very low blood concentrations suggest that little, if any, of the drug will be excreted into breast milk. Therefore, the use of chondroitin during lactation is probably compatible.
References
1.Chondroitin. The Review of Natural Products. St. Louis, MO: Wolters Kluwer Health, 2004.
2.Chondroitin Sulfate. Natural Medicines Comprehensive Database. Stockton, CA: Therapeutic Research Faculty, 2003:345–7.
3.Chondroitin. PDR Health. Available at http://www.pdrhealth.com/drug_info/nmdrugprofiles/nutsupdrugs/cho_0071.shtml. Accessed March 20, 2006.
4.Kamei T. The teratogenic effect of excessive chondroitin sulfate in the DDN strain of mice. Med Biol 1961;60:126–9. As cited in Shepard TH. Catalog of Teratogenic Agents. 10th ed. Baltimore, MD: The Johns Hopkins University Press, 2001:107–8.
5.Hamada Y. Studies on anti-atherosclerotic agents. IX. Teratological studies of sodium chondroitin polysulfate. Oyo Yakuri 1972;6:589–94. As cited in Shepard TH. Catalog of Teratogenic Agents. 10th ed. Baltimore, MD: The Johns Hopkins University Press, 2001:107.