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Prozac and Pregnancy

UPI Science News

BOSTON, Oct. 2, 1996 (UPI) -- Women who take Prozac during the last trimester of their pregnancy may be lowering the birth weight of their babies and increasing the risk of preterm delivery and other complications, California researchers warned Wednesday.

Babies exposed to Prozac during the first trimester and possibly later showed no major defects, but had a higher tendency for minor abnormalities than those whose mothers did not take Prozac.

However, the drug does not seem to cause any increase in miscarriages or stillbirths, the researchers reported in The New England Journal of Medicine.

The study authors, at the California Teratogen Information Service and University of California at San Diego, did not find the effects dramatic enough to advise women to avoid the antidepressant.

``It's between a woman and her doctor,'' said Christina Chambers, first author of the research report. ``The drug has certainly been a life-saver for many people.''

However, the March of Dimes issued a statement Wednesday urging ``pregnant women and those planning to become pregnant'' to ``try to avoid taking fluoxetine (Prozac) if possible until the drug's effects in pregnancy have been studied further.''

The makers of Prozac, Eli Lilly and Company in Indianapolis, objected on the grounds that other factors, such as depression itself, could have caused the effects seen in the California study.

``We're dismayed that the reaction to this article, which was limited in its methodologies, may be detrimental to the health of women,'' said Dr. David Goldstein, the company's senior clinical research physician.

If pregnant women were treated like lab rats, scientists could design bulletproof studies to clear up questions about drugs. However, several researchers pointed out that the kind of studies that can be done on humans -- the new California one as well as previous ones that found no problems with the drug -- have tricky limitations.

Dr. Elisabeth Robert from Institut Europeen des Genomutations in Lyon, France, commented, ``I do not think that fluoxetine or tricyclic antidepressant drugs have been clearly proved unsafe for pregnant women.''

In an editorial accompanying the article, Robert pointed out uncertainties such as the possibility that the complications could have come from the greater age of the women or other drugs they used.

``In sum, it seems unjustified to use these new results as a reason to withhold fluoxetine from women who require an antidepressant during pregnancy.''

Prozac may be the most commonly prescribed antidepressant in the United States, but Chambers and co-authors began their paper by saying ``its safety in pregnant women has not been adequately evaluated.''

Previous research projects found no increase in major birth defects or miscarriages, but Chambers said the study designs could have missed subtler effects. For example, data collected by the drug's makers had substantial gaps when people could not be reached for follow-up.

Chambers, Dr. Kenneth Lyons Jones (who helped identify Fetal Alcohol Syndrome) and colleagues compared the pregnancies of 228 women who took Prozac with 254 other women who did not use the antidepressant.

Researchers found that the 73 babies exposed to Prozac during the third trimester weighed about 6.6 ounces (188 grams) less than the 101 babies who had been exposed only during the first and second trimesters.

The reason could be that Prozac was limiting the amount of weight the mothers gained, which in turn would suppress the babies' weight, Chambers said.

For a baby already on the brink of falling into the low-birthweight category, those ounces could be a serious loss. ``From a public health point of view, it may be of importance,'' Chambers said.

Compared to babies whose only exposure was earlier in pregnancy, the ones affected by Prozac during the third trimester were 4.8 times more likely to be born prematurely and 2.6 times more likely to need care in a special nursing facility.

They were also 8.7 times more likely to show signs of struggle in adapting to life outside the womb, such as jitteriness or respiratory difficulty.

Jones examined 97 of the babies exposed to Prozac at least during the first trimester and found more minor abnormalities, harmless but rare traits like underdeveloped nails or an extra whorl in the hair. Only 6.5 percent of the control babies had as many as three of these minor abnormalities, but 15.5 percent of the Prozac babies did.

The minor abnormalities were not medically alarming themselves, but raised the possibility that they might be early signs of some deeper genetic problem, said Chambers. She pointed out that serious damage from prenatal exposure to substances like alcohol can show up first in babies as a characteristic pattern of smaller abnormalities.

The abnormalities in the Prozac babies did not show a pattern, said Chambers. ``The study does not support undue concern.''

However, she said the researchers are following the children as they grow, so future studies will be able to see whether Prozac in the womb affected their long-term development.

Until researchers collect more information, Dr. Richard Johnston, Jr., medical director for the March of Dimes encourages pregnant women to avoid Prozac if they can.

``Preterm births are a tremendous medical and economic problem in this country,'' Johnston said. ``The March of Dimes believes that any drug that may add to the risk of this very serious complication should be avoided whenever possible.''

(Written by UPI Science Writer Susan Milius in Washington)

Prozac Alternatives

I would recommend St. John's Wort. Just as effective as Prozac but with less side effects.

The usual dose is 300mg TID of a standardized prep containing 3% hypericum. Watch out for hypersensitivity to the sun.

St. Johns wart sound wonderful as an antidepressant. Do you have any references or dosage information or any experiences that you could share ?

The folks at the Journal of Geriatric Psychiatry and Neurology felt this was important enough to do a whole supplemental edition on it- Vol. 7, October 1994.

Risks of Prozac in Pregnancy

This recently appeared in a Employee Health newsletter: "The medical director of the White Plains, NY-based March of Dimes Birth Defects Foundation warns that pregnant women and those planning to become pregnant should try to avoid taking fluoxetine (Prozac) if possible until the drug's effects in pregnancy have been studied further. His comments come on the heels of an article in the Oct. 3, 1996, New England Journal of Medicine. " The high rate of prematurity among babies of women in this study who took Prozac during the last trimester of pregnancy is troubling" says Richard B. Johnston Jr., MD. Although the babies of women who took Prozac during pregnancy did not have more major birth defects, they did have a higher rate of minor physical signs that sometimes are associated with more serious, hidden defects. Serious defects in the development of the baby's central nervous system, for example, may take a year or two to become evident. Johnston says the March of Dimes advises women who are taking Prozac and who are planning to become pregnant in the near future to consult their physicians before they conceive about whether they are good candidates for Prozac, and whether a suitable alternative to this drug exists for them. Women who are currently pregnant and taking Prozac should not simply discontinue their medication, but should also consult their physicians. "'We recognize that there will be times when physicians and women decide that there is no good alternative to Prozac, but we urge them to weigh carefully the risks of taking this drug during pregnancy alongside the potential health benefits" says Johnston".

A new study in yesterday's New England Journal of Medicine by Dr. Gideon Koren of the University of Toronto turns up no evidence the Prozac during pregnancy affects the children's IQ or behavior. The article also states that the October study might he flawed because the complications in the October article failed to acknowledge that the complications might have been the result of the mental condition that prompted the use of Prozac and not the drug itself.

For more on Prozac and pregnancy see:

Conclusions. In utero exposure to either tricyclic antidepressant drugs or fluoxetine does not affect global IQ, language development, or behavioral development in preschool children. (N Engl J Med 1997;336:258-62.)

Check out this weeks New England Journal of Medicine:

Methods. We studied the children of 80 mothers who had received a tricyclic antidepressant drug during pregnancy, 55 children whose mothers had received fluoxetine during pregnancy, and 84 children whose mothers had not been exposed during pregnancy to any agent known to affect the fetus adversely. The children's global IQ and language development were assessed between 16 and 86 months of postnatal age by age-appropriate Bayley Scales of Infant Development or the McCarthy Scales of Children's Abilities (for IQ) and the Reynell Developmental Language Scales.

Results. The mean (+/-SD) global IQ scores were 118+/-17 in the children of mothers who received a tricyclic antidepressant drug, 117+/-17 in those whose mothers received fluoxetine, and 115+/-14 in those in the control group. The language scores were similar in all three groups. The results were similar in children exposed to a tricyclic antidepressant drug or fluoxetine during the first trimester and those exposed throughout pregnancy. There were also no significant differences in temperament, mood, arousability, activity level, distractibility, or behavior problems in the three groups of children.

Conclusions. In utero exposure to either tricyclic antidepressant drugs or fluoxetine does not affect global IQ, language development, or behavioral development in preschool children. (N Engl J Med 1997;336:258-62.)

The NEJM seems to be doing a series on fluoxetine.0

I am pre-conception counseling a patient and find she is on Prozac (Fluoxetine HCl). She has tried other SSRIs and they do not work as well for her mild depressive symptoms. I can't find any recent literature about Prozac and pregnancy, and I don't think it even has a pregnancy category, at least not per the insert.

See NEJM, 335, #4, Oct. 3, 1996

Conclusions. Women who take fluoxetine during pregnancy do not have an increased risk of spontaneous pregnancy loss or major fetal anomalies, but women who take fluoxetine in the third trimester are at increased risk for perinatal complications. (N Engl J Med 1996;335:1010-5.)

Methods. From 1989 through 1995, we prospectively identified 228 pregnant women taking fluoxetine. We compared the outcomes of their pregnancies with those of 254 women identified in a similar manner who were not taking fluoxetine. Results. The rate of spontaneous pregnancy loss did not differ significantly between the women treated with fluoxetine and the control women (10.5 percent and 9.1 percent, respectively), nor was the rate of major structural anomalies significantly different (5.5 percent vs. 4.0 percent). Among the 97 infants exposed to fluoxetine who were evaluated for minor anomalies, the incidence of three or more minor anomalies was significantly higher than among 153 similarly examined control infants (15.5 percent vs. 6.5 percent, P = 0.03). As compared with the 101 infants exposed to fluoxetine only during the first and second trimesters, the 73 infants exposed during the third trimester had higher rates of premature delivery (relative risk, 4.8; 95 percent confidence interval, 1.1 to 20.8), admission to special-care nurseries (relative risk, 2.6; 95 percent confidence interval, 1.1 to 6.9), and poor neonatal adaptation, including respiratory difficulty, cyanosis on feeding, and jitteriness (relative risk, 8.7; 95 percent confidence interval, 2.9 to 26.6). Birth weight was also lower and birth length shorter in infants exposed to fluoxetine late in gestation.

I have had several patients on Prozac throughout their pregnancies. One newborn had tachypnea which resolved spontaneously. The baby went home with mom on the second postpartum day.

If the prospective mom has a Bipolar Disorder, she should be counseled about the familial predilection of these disorders. See the following.