Thalidomide is a drug originally marketed as a sedative outside the United States from the 1950s until the early 1960s when it was linked with severe birth defects. In addition to causing serious fetal deformities, thalidomide has been associated with other adverse reactions, including peripheral neuropathy, a disorder that, in some patients, has resulted in permanent nerve damage. The product was never approved for use in the United States until now. Additionally, 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 starting thalidomide therapy. Pregnancy testing will continue to be required weekly during the first month of use, then monthly thereafter in women with regular cycles, or every two weeks if cycles are irregular.
Prescriptions are only for one month's supply.
Women must use two reliable forms of contraception simultaneously while taking the drug. Male patients will receive written and oral warnings of the risk of possible contraception failure and of the need to use condoms when having intercourse with women of childbearing age. It is unknown whether thalidomide is present in sperm or semen or whether its presence in sperm or semen would affect fetal development. While birth defects are the most widely known side effect of thalidomide, this drug also can cause a potentially irreversible kind of nerve damage known as peripheral neuropathy, particularly when it is used chronically over a period of months. More information is needed to determine how dose and use of the drug affects onset of this side effect and irreversibility.