Tiludronate Pregnancy and Breast Feeding Warnings
Tiludronate is also known as: Skelid
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tiludronate while you are pregnant. It is not known if Tiludronate is found in breast milk. If you are or will be breast-feeding while you use Tiludronate , check with your doctor. Discuss any possible risks to your baby.
Tiludronate Pregnancy Warnings
Tiludronate has been assigned to pregnancy category C by the FDA. Animal studies using tiludronate have revealed maternal toxicity and fetal effects at doses 2 to 10 times the recommended human dose based on body surface area (BSA). There are no controlled data in human pregnancy. Tiludronate is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Animal studies using tiludronate at doses 2 times the recommended human dose based on body surface area (BSA) beginning day 15 of gestation to day 25 postpartum resulted in protracted parturition and maternal death thought to be due to hypocalcemia. Dosages 2 to 5 times the recommended human dose (BSA) during days 6-18 of gestation resulted in dose-related scoliosis attributed to the pharmacologic properties of the drug. Slight maternal toxicity (decreased weight gain), increased postimplantation loss, decreased fetal numbers and body weight occurred at doses 7 times the recommended human dose (BSA) during days 6-15 of gestation. Paw malformations (shortened or missing digits, blood blisters between or in place of digits) occurred in six fetuses from the same litter. Doses 10 times the recommended human dose (BSA) days 6-15 of gestation resulted in maternal toxicity (decreased body weight), reduced percentage of implantation, increased postimplantation loss, and increased intra-uterine deaths. Evidence of teratogenicity was not noted.
Tiludronate Lactation Warnings
There are no data on the excretion of tiludronate into human milk. 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.
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.
