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Related Experiment Videos

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

Kathleen Uhl1, Edward Cox, Rose Rogan

  • 1US Food & Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland 20993, USA. kathleen.uhl@oc.fda.gov

Drug Safety
|March 30, 2006
PubMed
Summary

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The System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) program effectively managed thalidomide risks. Vigilance is crucial, and healthcare providers should note the occurrence of false-positive pregnancy tests in women of childbearing potential.

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.

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  • 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.