Potential risk in pregnancy while on Gleevec

[Guest guest]

March 07, 2008. NEW YORK (Reuters Health) - " The majority of women who become

pregnant while taking the cancer drug Gleevec, usually for a type of blood

cancer called chronic myeloid leukemia, will probably have a successful outcome.

However, there is a substantial risk of serious fetal malformations, according

to a study reported this week. Some research has suggested that Gleevec, known

generically as 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 drug.

" Imatinib has been in use for nearly 10 years, yet data regarding its effects on

pregnancy is limited, Dr. Seonaid M. Pye and colleagues note. 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, 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. Cancer Center in Houston. Pregnancy outcome data

were available for 125 women.

Sixty-three women -- roughly half -- delivered normal infants and 35 women (28

percent) elected to terminate their pregnancy, including 3 cases prompted by the

identification of a fetal abnormality. Another 18 pregnancies ended in

miscarriage. The remainder of the births -- 9 in total -- involved the delivery

of an infant with abnormalities, including 1 case of stillbirth. The

abnormalities included exomphalos (umbilical hernia), renal agenesis

(underdeveloped kidney), and hemivertebrae (underdeveloped spine) and, in the

stillborn infant, meningocele (cerebral hernia).

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, " 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, " the study

leader added. "

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SOURCE: Blood, online March 5, 2008. Reuters Limited. All

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FYI,

Lottie