Thalidomide use in the US : experience with pregnancy testing in the S.T.E.P.S. programme.
BACKGROUND
In 1998, thalidomide (Thalomid), a known human teratogen, was approved by the US FDA for the treatment of erythema nodosum leprosum. To prevent fetal exposure to thalidomide, a restricted distribution risk management programme, the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.), was implemented. All clinicians, pharmacists and patients who prescribe, dispense and receive thalidomide, respectively, are required to enroll in S.T.E.P.S. Sexually active females of childbearing potential must use two methods of birth control before, during and after treatment. These patients must also have a negative pregnancy test within 24 hours before beginning therapy and periodically while on therapy. The objective of this report is to summarise the patterns of thalidomide use and to describe the occurrence of positive pregnancy tests in females of childbearing potential while they were using thalidomide in the S.T.E.P.S. programme in the US.


METHODS
A retrospective review of patients receiving thalidomide within the S.T.E.P.S. programme from September 1998 to 31 December 2004 to determine the occurrence of positive pregnancy tests whilst on treatment.


RESULTS
Approximately 124,000 (43% female) patients were registered within the S.T.E.P.S. programme between September 1998 and 31 December 2004. Approximately 6,000 patients were females of childbearing potential, representing 5% of all patients and 11% of all female patients. Between 30 July 2001 and 31 December 2004, >88% of thalidomide use was for oncological conditions. There were 72 females of childbearing potential who had positive pregnancy tests. Sixty-nine of these patients had false positive pregnancy tests. Of the remaining three, one woman was pregnant while on thalidomide. This patient had an initial negative test and received thalidomide. Therapy was stopped when she had a positive pregnancy test. This pregnancy resulted in a miscarriage. Two additional patients were determined to be pregnant before receiving thalidomide.


CONCLUSIONS
The S.T.E.P.S. programme is critical to managing the risks of thalidomide-associated teratogenicity. Sustained vigilance among health care providers and patients receiving thalidomide is essential to its continued success. Health care providers should be aware of the occurrence of false-positive pregnancy tests in females of childbearing potential receiving thalidomide.
Uhl
Kathleen
K
US Food & Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland 20993, USA. kathleen.uhl@oc.fda.gov
Cox
Edward
E
Rogan
Rose
R
Zeldis
Jerome B
JB
Hixon
Dena
D
Furlong
Lesley-Anne
LA
Singer
Sarah
S
Holliman
Tracy
T
Beyer
Joanne
J
Woolever
William
W
D011307:Drug Prescriptions / Q000592:standards*; D004335:Drug and Narcotic Control / Q000458:organization & administration*; D005260:Female; D006801:Humans; D011247:Pregnancy; D011258:Pregnancy Tests; D012189:Retrospective Studies; D013723:Teratogens; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D014481:United States
D013723:Teratogens; D013792:Thalidomide