Thalidomide use in the US : experience with pregnancy testing in the S.T.E.P.S. programme

Area of Science:

• Pharmacovigilance
• Teratology
• Risk Management Programs

Background:

• Thalidomide (Thalomid) approved in 1998 for erythema nodosum leprosum, a known teratogen.
• The System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) program implemented to prevent fetal exposure.
• S.T.E.P.S. mandates enrollment for prescribers, dispensers, and patients, with strict pregnancy prevention protocols for females of childbearing potential.

Purpose of the Study:

• To summarize thalidomide usage patterns within the S.T.E.P.S. program in the US.
• To describe the incidence of positive pregnancy tests among females of childbearing potential undergoing thalidomide therapy.

Main Methods:

• Retrospective review of patients enrolled in the S.T.E.P.S. program from September 1998 to December 2004.
• Analysis focused on identifying positive pregnancy tests in females of childbearing potential during thalidomide treatment.

Main Results:

• Over 124,000 patients registered in S.T.E.P.S.; approximately 6,000 were females of childbearing potential.
• From July 2001 to December 2004, over 88% of thalidomide use was for oncological conditions.
• 72 females of childbearing potential had positive pregnancy tests; 69 were false positives. One patient became pregnant on thalidomide (resulting in miscarriage), and two were pregnant prior to treatment initiation.

Conclusions:

• The S.T.E.P.S. program is essential for managing thalidomide's teratogenic risks.
• Continuous vigilance from healthcare providers and patients is vital for the program's success.
• Healthcare providers must be aware of the potential for false-positive pregnancy tests in patients receiving thalidomide.