United States of America. The Food and Drug Administration has cleared thalidomide (Thalidomid: Celgene) for marketing as a treatment for erythema nodosum leprosum (Hansen’s disease), while at the same time imposing unprecedented restrictions on the drug’s distribution. Because of its well-known potential for causing birth defects, thalidomide will be among the most tightly restricted drugs ever to be marketed in the United States.
To prevent fetal exposure to thalidomide, the manufacturer has developed the System for Thalidomide Education and Prescribing Safety (STEPS) programme. Only physicians who are registered in the STEPS programme may prescribe thalidomide to patients, and those patients - both women and men - must comply with the mandatory contraceptive measures, patient registration and patient surveys.
Additionally, women 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 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 adverse effect of thalidomide, this drug can also cause a potentially irreversible form of nerve damage known as peripheral neuropathy, particularly when it is used long-term over a period of months.
[See also Pharmaceuticals Newsletter Nos. 11&12, November & December 1997]
Reference: FDA Talk Paper T98-44 dated 16 July 1998.