Thalidomide Pregnancy and Breast Feeding Warnings
Thalidomide is also known as: Thalomid
Overview
Use of Thalidomide during pregnancy has resulted in severe birth defects and death of the fetus. If you think you may be pregnant, miss your menstrual period, experience unusual menstrual bleeding, or stop using birth control, contact your doctor at once. If you become pregnant while using Thalidomide , consult an obstetrician/gynecologist experienced in reproductive toxicity. It is unknown if Thalidomide is found in breast milk. Do not breast-feed while taking Thalidomide .
Thalidomide Pregnancy Warnings
Thalidomide has been assigned to pregnancy category X by the FDA. The use of thalidomide in humans has produced fetal malformations such as phocomelia, amelia, hypoplasticity, external ear abnormalities, facial palsy, eye abnormalities, congenital heart defects, coloboma of the iris and choroid, agenesia of the appendix, abnormalities of the alimentary tract, urinary tract and other defects of internal organs. Thalidomide is contraindicated in pregnant women and women of childbearing age. Because thalidomide is present in the semen of patients receiving the drug, males receiving thalidomide must always use a latex condom during any sexual contact with women of childbearing potential even if they have had a successful vasectomy.
Even a single dose of thalidomide has been reported to cause human birth defects. The risk to the fetus from the semen of male patients taking thalidomide is unknown. When there is no alternative treatment, women of childbearing age may be treated with the drug if precautions are taken to prevent pregnancy. Even women with a history of infertility must follow this protocol. Sexual abstinence or two methods of birth control must be used (one must be classified as a highly effective method of birth control such as IUD, tubal ligation, hormonal contraception or vasectomy and one additional method of birth control classified as effective birth control such as latex condom, diaphragm or cervical cap) for one month before beginning treatment with thalidomide, during therapy with the drug and one month after the drug has been discontinued. Women of childbearing potential must acknowledge, in writing, their understanding of the warnings and of the need to use two reliable methods of contraception for 4 weeks prior to the beginning of thalidomide therapy, during thalidomide therapy, and for 4 weeks after discontinuation of thalidomide therapy. Pregnancy testing is recommended using a method that has a sensitivity of at least 50 milli-international units/mL, 24 hours before beginning the drug therapy and weekly during the first month of therapy. Pregnancy testing should be performed monthly by women who have regular menstrual cycles and every two weeks in women who have irregular menstrual cycles. Pregnancy testing should also be performed if a menstrual cycle is missed or if bleeding between cycles occurs in the woman while taking the drug. If pregnancy occurs during drug therapy, thalidomide must be discontinued immediately. Any suspected fetal exposure must be reported to the FDA using the MedWatch number 1-800-FDA-1088 and to the Celgene Corporation. The patient must be referred to an obstetrician/gynecologist who is experienced in reproductive toxicity for further evaluation.
Thalidomide Lactation Warnings
There is no data on the excretion of thalidomide into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, the manufacturer recommends a decision to be made whether or not to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the nursing woman.
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