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 Blood, 15 June 2008, Vol. 111, No. 12, pp. 5505-5508.
Prepublished online as a Blood First Edition Paper on March 5, 2008; DOI 10.1182/blood-2007-10-114900.

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CLINICAL TRIALS AND OBSERVATIONS

The effects of imatinib on pregnancy outcome

Seonaid M. Pye1, Jorge Cortes2, Patricia Ault2, Alan Hatfield3, Hagop Kantarjian2, Richard Pilot3, Gianantonio Rosti4, and Jane F. Apperley1

1 Department of Haematology, Division of Investigative Science, Imperial College, London, United Kingdom; 2 University of Texas M. D. Anderson Cancer Center, Houston; 3 Novartis Pharmaceuticals, East Hanover, NJ; and 4 Institute of Hematology and Medical Oncology Seràgnoli, Bologna, Italy

Imatinib has now been in use for almost 10 years. Despite this cumulative experience, little is known about its effects on pregnancy; as a result, there are few published data to facilitate the counseling of women who conceive while taking imatinib. The results we now present provide information which may be of use in such circumstances. Of 180 women exposed to imatinib during pregnancy, outcome data are available for 125 (69%). Of those with known outcomes, 50% delivered normal infants and 28% underwent elective terminations, 3 following the identification of abnormalities. There were a total of 12 infants in whom abnormalities were identified, 3 of which had strikingly similar complex malformations that are clearly a cause for concern. It appears that although most pregnancies exposed to imatinib are likely to have a successful outcome, there remains a risk that exposure may result in serious fetal malformations.


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