Celecoxib Pregnancy and Breastfeeding Warnings
Celecoxib is also known as: Celebrex
Celecoxib Pregnancy Warnings
Celecoxib has been assigned to pregnancy category C for the first 30 weeks of gestation and category D from week 30 forward by the FDA. Animal studies have revealed evidence of teratogenicity. Nonteratogenic effects in animal studies included pre-and post-implantation losses and reduced embryo/fetal survival. There are no controlled data in human pregnancy. Celecoxib is only recommended for use during pregnancy when benefit outweighs risk. The manufacturer recommends that celecoxib be avoided in late pregnancy (third trimester) due to the risk of premature closure of the ductus arteriosus.
Celecoxib Breastfeeding Warnings
Limited data show celecoxib is excreted into human milk in small amounts. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Celecoxib was measured in the milk of a 40-year-old woman after four doses of celecoxib 100 mg. She withheld breast-feeding her baby for 48 hours. Plasma concentrations from this woman predicted that nearly all of the drug would be eliminated from the breast milk within 24 to 36 hours (approximately 5 half-lives) after the mother had finished taking celecoxib. A report of two breastfed infants 17 and 22 months of age did not show any adverse events.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.