Raloxifene Pregnancy and Breastfeeding Warnings

Raloxifene is also known as: Evista

Raloxifene Pregnancy Warnings

In rat studies, decreased fetal development and developmental abnormalities (wavy ribs, kidney cavitation) occurred at doses greater than or equal to 0.2 times the human dose based on body surface area. Treatment of rats at gestation with doses ranging from 0.2 to 1.6 times the human dose resulted in delayed and disrupted parturition, decreased neonatal survival, altered physical development, sex- and age-specific reduction in growth and changes in pituitary hormone content and decreased lymphoid compartment size in offspring. At 10 mg/kg, raloxifene resulted in maternal and progeny morbidity and death. Effects in adult rats at four months of age revealed uterine hypoplasia and reduced fertility but no ovarian or vaginal pathology was observed.

Raloxifene has been assigned to pregnancy category X by the FDA. Animal studies have revealed evidence of abortion, fetal heart anomalies, hydrocephaly, retardation of fetal development and survival, and changes in pituitary hormone content. There are no controlled data in human pregnancy. Raloxifene use is considered contraindicated during pregnancy or in any woman planning to become pregnant.

Raloxifene Breastfeeding Warnings

There are no data on the excretion of raloxifene into human milk. Raloxifene is considered contraindicated during breast-feeding by the manufacturer.

Treatment of lactating rats with doses ranging from 0.02 to 1.6 times the human dose resulted in delayed and disrupted parturition, decreased neonatal survival, altered physical development, sex- and age-specific reductions in growth and changes in pituitary hormone content and decreased lymphoid compartment size in offspring.

See Also...

• raloxifene Consumer Information
• Pregnancy Support Group
• FDA Pregnancy Categories
• Medicine use during Pregnancy
• Medicine use while Breastfeeding
• Safe Medications during Breastfeeding

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 drug information 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 drug combination in no way should be construed to indicate that the drug of drug 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 in 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.