Symptoms include a burning sensation, numbness, or tingling in the arms, hands, legs, or feet. Because of thalidomide's special danger to a developing baby, the FDA requires special safeguards never before imposed with any drug. Thalidomide may be dispensed only by licensed pharmacists who are registered in the S.T.E.P.S. program and have been educated to understand the risk of severe birth defects if thalidomide is used during pregnancy. In addition, female patients' prescriptions will not be filled without a physician's written report of a negative pregnancy test that has been conducted within 24 hours of stating thalidomide therapy. Pregnancy testing will continue to be required weekly during the first month of use, than monthly thereafter in women with regular cycles, or every two weeks if cycles are irregular.
Prescriptions are only for one month's supply.
A female patient must abstain from sexual intercourse or use two highly effective methods of birth control at the same time for at least one month before receiving thalidomide and continue their use until one month after the last thalidomide dose. Women being treated with thalidomide should refrain from any other activities that could result in pregnancy, such as assisted fertilization methods. Breastfeeding a baby and donating blood are also prohibited. Male patients must abstain from sexual intercourse or use a condom during intercourse while taking thalidomide and for one month after, because it is not known if thalidomide in semen is a hazard. Donating sperm or blood is also prohibited.