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A Consumer Speaks Out

Clozapine and pregnancy: one woman's decision by Martha Lautenbach Wolff

Note: This is an individual account of the author's individual experience. NAMI neither agrees nor disagrees with the author's decisions.

Ten months ago I gave birth to a healthy baby boy. I had been taking 200 milligrams of clozapine (Clozaril) daily for the previous six years. I was worried--and so were my doctors--about how the medication might affect my baby and how not taking the medicine might affect my functioning as a pregnant woman.

There are so many factors and considerations to take into account when deciding whether or not to have a baby. Add to that having a condition that necessitates taking clozapine, and the decision becomes confusing and truly overwhelming. In the end the decision is completely personal, but in this article I will share with you the information that I have compiled over the course of several years concerning becoming pregnant on clozapine. One note, however: the information I share in this article is only about clozapine, which is an atypical drug in its class. It does not pertain to other anti-psychotic drugs.

Before trying clozapine, I had struggled with depression for many years, and I finally entered a hospital. I spent two and one-half harrowing years there trying every drug for what by that time was diagnosed as a schizo-affective disorder. Nothing worked.

With the help of my mother, I was able to be the first person to try clozapine at the New York Hospital/Cornell Medical Center. Within about three months I was able to leave the hospital and function on my own. The next five years would be a difficult process of getting my life back together with day hospital, school, and finding a job. I met the man I would marry and--after a two- year engagement--we were married. I was thrilled to be able to continue my life in a normal, healthy way. Having a baby was always part of my dream, but I didn't know if it would be possible on clozapine. So, after nearly seven years of taking clozapine, I started researching and trying to decide.

Because clozapine is a relatively new drug in the United States, there have been very few studies on pregnant women taking the drug. Advice from psychiatrists was almost uniformly the same: "Don't take clozapine while pregnant! Not enough is known about the effects of the drug on the fetus." One doctor advised cutting the dose of clozapine to a minimum during the first three months of pregnancy, which is the crucial time for fetal development. Although I did receive advice, I felt I was alone in the making of this decision. I was venturing into the unknown.

In an article titled "Psychotropic Drugs in Pregnancy and Lactation," authors Harold Goldberg, M.D., and Robyn Nissim, B.A., suggest that studies prove that the fetus is at greatest risk of negative effects from clozapine during the first three months of gestation, when organs are beginning to develop. Clozapine is a "category B" drug, which means that in animal studies there were no adverse effects on the fetus--but there are no extensive controlled studies in pregnant women. Clozapine, however, does cross the placenta to some extent, and the fetus absorbs more of the drug than the mother. For this reason, the mother may have to increase her dosage of the drug to maintain its effectiveness in controlling the symptoms for which it was prescribed.

The fetus and the mother exist in equilibrium, and this can pose problems right before and during birth. According to Goldberg and Nissim, if clozapine is concentrated in the fetus right before birth, the baby will go through withdrawal after birth, and the effect could be toxic. One possible reaction could be a sedation effect known as "floppy baby syndrome," which disappears as the clozapine metabolizes or passes through the system. Some of the symptoms of this syndrome include hyperactivity, tremors, motor restlessness, and abnormal movements that could last for several months, but eventually subside. These symptoms seem to be due to the baby's immature metabolism. The authors state that there are two schools of thought about how to best protect a baby from the effects of withdrawal (even though their conclusions are inconclusive due to lack of studies). The authors recommend discontinuing clozapine five to ten days before delivery to avoid the symptoms; other doctors think it is safer to let the baby withdraw after birth.

I did not reduce my dosage of clozapine during my pregnancy. I had experimented with stopping the medication and reducing the dose. I found that symptoms returned promptly and to such a degree of severity that reducing the dose while I was pregnant would have been unwise. However, I did reduce by half the clozapine the night before I was scheduled to go into the hospital. I started again the full dose the day after my son was born. He did have some breathing difficulty, but it corrected itself quickly. There was no evidence that this was a result of withdrawal. He also did not exhibit any of the possible side effects such as motor restlessness.

The authors of the article mentioned above suggest that physicians (and patients) need to weigh controlling schizophrenia against the risk of the drug to the mother.

I found several other studies done on women on clozapine who became pregnant. The first appeared in the American Journal of Psychiatry in June 1994. It reported on a woman with schizophrenia who had been in a five-year remission since taking clozapine. In preparation for her pregnancy she stopped taking the drug, but was forced to resume taking it when her symptoms returned. During the last nine weeks of her pregnancy, her medication was reduced. She delivered normally, and they baby showed no adverse effects and had no psychomotor abnormalities at six months. The conclusion was the recommendation to lower the dose of clozapine as much as possible a few days before birth to avoid "floppy baby syndrome." Also, the authors recommend that mothers should not breastfeed their babies because clozapine does pass through into the infant in breast milk.

The other study, in the January 1993 issue of the American Journal of Psychiatry, reported that--as of December 1990--14 women were known to be exposed to clozapine during their pregnancies with no adverse effects on the fetuses.

The Clozaril information packet distributed by Sandoz, the manufacturer of the drug, backs up these findings. Reproduction studies in rats and rabbits given 2.5 to 7.0 times the human dose showed no evidence of impaired fertility or harm to the fetus. Sandoz recommends that clozapine should not be administered to pregnant women unless clearly needed. Their reasons include: 1) adequate, well-controlled studies have not been performed; 2) animal studies are not always transferable to humans; and 3) it is advisable to minimize use of all drugs during pregnancy. Sandoz also agrees with the recommendation to avoid breastfeeding while on clozapine.

The University of Connecticut Health Center Pregnancy Exposure Information Service also found that clozapine did not affect genetic material in bacterial or mammalian test systems. Again, they said that animal studies suggest that clozapine is not a cause of birth defects, but a small risk does exist--but a risk no greater that for the general population. Also mentioned is the possible agranulocytosis, which is a toxic effect on bone marrow. It can be fatal if not caught and reversed early enough. It is not clear if this problem could occur in the fetus or newborn.

And there is a risk of seizures, but there is little data on whether the fetus or newborn might be affected, according to the December 1990 issue of the International Drug Therapy Newsletter.

Some doctors warn that if you are on clozapine, you have a severe illness and, therefore, they don't recommend pregnancy. There is a potential risk of passing it on to your children. Also, doctors are concerned with the parenting skills--or lack of them-- in people with serious brain disorders.

In conclusion, this decision about pregnancy is completely personal. As scared as I was, I felt there was enough positive research and very little negative. I believed I could handle being a parent because, on the medication, I was well enough for long enough. I decided that life has risks at all times, and I really wanted to bring a baby into this world. I ventured into the unknown, but life itself is the great unknown.

And I hope that, with what I have written, the unknown is a little more known.