The Zyprexa Chronicles: Reports Of Zyprexa Killing, Injuring Infants

There was an alarming letter in this month's American Journal of Psychiatry, reporting on a child born with a clubfoot and a hole in its heart (the baby's gender is not specified). The case occurred in Israel and the doc's report reads, in part:

""Ms. A," a 25-year-old primigravida woman, had not received any prescribed medication other than olanzapine 10 mg daily. She had not been smoking, using drugs, or drinking alcohol during her pregnancy. There was no family history of birth defects; no viral infections occurred during pregnancy, and no work exposures were present. There was no consanguinity between her and the father of the baby. The baby was born with an atrioventricular canal defect and unilateral clubfoot. No additional phenotypic abnormalities were observed, and the karyotype was found to be 46XY. The baby was treated for the clubfoot with a plaster cast with satisfactory results and at the age of 6 months underwent open heart surgery because of the atrioventricular canal, with full recovery."

Hey, Lilly did you guys pay for the surgery?

The doctor adds that generally there are few reported problems involving pregnancies and Zyprexa. Then he notes:

"Other case reports in the literature involving treatment with olanzapine throughout pregnancy include a report of a baby born with hip dysplasia (7) as well as reports of a meningocele and ankyloblepharon (8). Association between schizophrenia itself and congenital cardiac anomalies was suggested recently (9) and therefore could be the reason for the atrioventricular canal in our patient’s baby, regardless of the olanzapine treatment. Additional reports would be helpful in clarifying whether our case was incidental or because of a teratogenic effect of olanzapine, and the limitations of a single case report need to be taken into consideration."

The FDA's adverse events database has, thankfully, been downloaded and made available to the public in an easy to use form by Psychdrugdangers.com (the FDA's system isn't easy to work with for anyone other than computer jocks). Going to the database there and filtering by age 0 to 4 and by Zyprexa, we come up with all manner of problems associated with use of the drug in moms and newborns: deaths, diabetes in a 6-month-old, convulsions, respiratory problems and more. You can go to that above link and figure out how to filter the data for yourselves. Prepare to be disgusted.

I don't mean to suggest that there is a 1:1 correlation between the use of Zyprexa and birth defects and infant deaths. What I mean to state is that there are oodles of cases in that database of problems with Zyprexa's use during pregnancy and that a medical doctor felt there was enough of a connection to file a report with the FDA. I bet there are many more cases that have gone unreported in this and other countries. I used the database to look for similar problems related to other atypicals in newborns and found very few. Yes, olanzapine (Zyprexa) is one special molecule.

I hope the FDA looks into this matter.