Imatinib Use During Pregnancy May Cause Serious Fetal Abnormalities

Imatinib Use During Pregnancy May Cause Serious Fetal Abnormalities

The majority of women who become pregnant while taking imatinib, usually for treatment of chronic myeloid leukemia, will probably have a successful outcome. However, there is a substantial risk of serious fetal malformations, including exomphalos and renal agenesis, according to study findings reported in a March 5 online issue of Blood.

Some research has suggested that imatinib may cross the placenta and damage the developing cells. The drug's label reflects this potential risk and warns women to avoid pregnancy while using the agent.

Imatinib has been in use for nearly 10 years, yet data regarding its effects on pregnancy is limited, lead author Dr. Seonaid M. Pye and colleagues comment. This lack of information has made it difficult to counsel women who conceive while taking the drug.

To better understand the drug's impact on pregnancy outcomes, Dr. Pye, from Imperial College, London, and associates reviewed the records of 180 pregnant imatinib users who were reported to drugmaker Novartis, the Hammersmith Hospital in London, or M. D. Anderson Cancer Center in Houston. Pregnancy outcome data were available for 125 of the cases.

Sixty-three women (50%) delivered a normal infant and 35 women (28%) underwent elective termination, including 3 cases prompted by the identification of a fetal abnormality. Another 18 pregnancies ended in miscarriage.

The remaining 9 cases involved the delivery of an infant with abnormalities, including 1 case of stillbirth. The abnormalities included exomphalos, renal agenesis, hemivertebrae, and, in the stillborn infant, meningocele.

The fact that some of the abnormalities had previously been reported in animal studies of imatinib suggests that they were, in fact, caused by exposure to the drug.

"Our study suggests that a concern about conceiving a child while taking imatinib is justified and that patients should be advised to avoid conception while on treatment," Dr. Pye said in a statement. "In those patients who do become pregnant, balancing the risk of the fetus from taking therapy to the risk of the mother from interrupting therapy will be an individual decision."

SOURCE:

Blood 2008.

Thanks to Reuters Health

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