Azelaic acid topical Pregnancy and Breastfeeding Warnings
Azelaic acid topical Pregnancy Warnings
Azelaic acid topical has been assigned to pregnancy category B by the FDA. There are no controlled data of topically administered azelaic acid in human pregnancy. High-dose animal studies have revealed evidence of embryotoxicity when azelaic acid is given orally. Azelaic acid should only be used during pregnancy when need has been clearly established.
High dose animal studies have revealed evidence of embryotoxicity when azelaic acid is given orally. In addition, slight disturbances in the postnatal development of fetuses was noted in rats at oral doses that generated some maternal toxicity.
Azelaic acid topical Breastfeeding Warnings
Azelaic acid may be excreted into human milk. In vitro, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0 at azelaic acid concentrations of 25 mcg/mL. However, since less than 4% of a topical dose is absorbed systemically, the amount in milk is expected to be minimal. The manufacturer recommends that caution be used when administering azelaic acid to nursing women.
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.