Prozac/Serafem (fluoxetine)
Organization of Teratology Information Specialists, 2004 See article at otispregnancy.org
[len:11411, cleaned:] For more information regarding OTIS or a Teratology Information Service in your area, call OTIS Information at (866) 626-6847 or visit us online at: www.OTISpregnancy.org. Prozac (fluoxetine) and Pregnancy The information below will help you determine if your prenatal exposure to Prozac represents an increased fetal risk. With every pregnancy, all women have a 3 to 5 percent chance to have a baby with a birth defect. What is Prozac? the first trimester. No study found an increased risk for Prozac is a medication commonly used to treat major structural birth defects (those requiring surgery depression. Prozac is also used to treat obsessive- or reducing function). One study has identified an compulsive disorders and eating disorders (bulimia increased rate of three or more minor birth defects nervosa). The generic name of Prozac is fluoxetine. (those not medically or functionally significant) among children exposed to Prozac in the first trimester. When I am taking Prozac, but I would like to stop three or more minor birth defects are seen together, a taking it before becoming pregnant. How long major birth defect (including learning problems) occurs does Prozac stay in your body? more often, although this was not seen in the Prozac The liver breaks down Prozac. Each study. individual's ability to break down the medication is different. On average, Prozac has a half-life (time it Will taking Prozac have any effect on my baby's takes to eliminate one half of the drug from the body) behavior and development? of two to three days, but may be found in your system Studies have begun to look at the possible for several weeks after you stop taking it. Studies have long-term effects on infants exposed to Prozac during shown that the levels are fairly low after one to two pregnancy. Prozac affects the mother by changing weeks. An active metabolite of Prozac called chemical levels in the brain. These changes could also norfluoxetine has a half-life of seven to sixteen days, have an effect on fetal brain development. Two studies but can remain in the body for a much longer time examining development in children at 16 months to 7 period. Please talk to your doctor before you stop years of age, did not find differences between exposed taking Prozac. The benefits of taking the medication and unexposed children. These studies are reassuring; for your specific situation, and any possible adverse however, more studies are needed before we can be outcomes of not taking it, should be discussed with certain of the effects on the fetal brain. your doctor. I have heard that Prozac can cause a Can taking Prozac make it more difficult for me miscarriage. Is this true? to become pregnant? Although not conclusive, there does not appear Animal studies have not shown any effect on to be an increased risk for miscarriage with the use of fertility with the use of Prozac. There have been Prozac in pregnancy. One study did suggest an reports of lack of orgasm or delayed orgasm in women increased risk for miscarriage, but this was thought to and men who take Prozac. There have also been be related to the maternal depressive disorder itself. reports of women who have had infertility problems, and who developed regular periods and ovulation after I need to take Prozac throughout my entire being treated with Prozac. Further studies are needed to pregnancy. Will it cause withdrawal symptoms in determine Prozac's effect on fertility. my baby? Since the drug has a long half-life, it is Can taking Prozac during my pregnancy cause unlikely that there is a withdrawal effect. Most infants birth defects? exposed to Prozac during the last three months of Prozac is one of the better-studied pregnancy do not have problems. Some newborns antidepressants in pregnancy. There are reports of exposed to Prozac during the last few months of nearly 2,000 pregnancies exposed to Prozac during pregnancy have had irritability, continuous crying, tremors, increased or decreased muscle tone, breathing problems and other problems after birth. These exposed to Prozac in breast milk have not been symptoms typically disappear within the first week of completed. life and are not considered life threatening. The conclusion of the Committee on Drugs of Are there any other problems Prozac can cause the American Academy of Pediatrics is that when used in the third trimester? antidepressants are "drugs whose effect on nursing Further research is needed to answer this infants is unknown but may be of concern". Please talk question. One study found that third trimester use of to your health care provider if you wish to breastfeed Prozac compared to first trimester use increased the while taking Prozac. chances for premature delivery, higher rates of care in the newborn special-care nursery, and lower birth June 2001 Copyright by OTIS, Reproduced by permission. weight and length. In this study, women who stopped using Prozac by the end of the second trimester do not References: seem to be at an increased risk for these problems. Addis, A. and G. Koren. Safety of fluoxetine during the first trimester Another study did not confirm these findings. Studies of pregnancy: meta-analytical review of epidemiological data. have shown that prematurity and other pregnancy Teratology (abst). 55:37, 1997 American Academy of Pediatrics Committee on Drugs: The transfer of complications may be related to the maternal drugs and other chemicals into human milk. Pediatrics 93:137-150, depressive disorder itself rather than to the medication 1994. exposure. Burch, K.J. and B.G. Wells. Fluoxetine/Norfluoxetine concentrations in human milk. Pediatrics 89:676-677, 1992. Chambers, C., et al . Pregnancy outcomes in women exposed to Some people who take Prozac may experience fluoxetine. Teratology 47:386, 1993. Chambers, C., et al . Outcomes in pregnant women taking fluoxetine. increased bruising. There has been a similar effect seen NEJM 335(4): 1010-1015, 1996. in a newborn whose mother took Prozac throughout the Chambers C.D., et al . Weight gain in infants breastfed by mothers who pregnancy. take fluoxetine. Pediatrics 104(5): I1-15, 1999. Eli Lilly and Company: January 2001 _ Correspondence. Goldstein, D.J. Effects of third trimester fluoxetine exposure on the Should I stop taking Prozac during my newborn. J Clin Psychopharmacol 15:417-420, 1995. Goldstein, D.J., et al . Effects of first-trimester fluoxetine exposure on pregnancy? the newborn. Obstet Gynecol 89:713-718, 1997. In order to receive the most thorough care Hale, T.W. Medications and Mother's Milk 1996, Fifth Edition. Pharmasoft Medical Publishing, Amarillo TX. 1996. during pregnancy, you should contact your health care Isenberg, K.E. Excretion of fluoxetine in human breast milk. J Clin provider before making any changes in medication or Psychiatry 51:169, 1990. stopping use any time during pregnancy. The benefits Lilly Research Laboratories, Written Correspondence, 1995. Lester, B.M., et al . Possible association between fluoxetine of taking Prozac for your specific situation, and the hydrochloride and colic in an infant. J Am Acad Child Adolesc potential risks to the baby, should be considered before Psychiatry 6:1253-1255, 1993. a decision is made. Mattson, S.N., et al. Neurobehavioral follow-up of children prenatally exposed to fluoxetine. (abst) Teratology 59: 376, 1999. Mhanna, M.J., et al . Potential fluoxetine chloride (Prozac) toxicity in a Can I take Prozac while breastfeeding? newborn. Pediatrics 100: 158-159, 1997. Michelson, D., et al. Abrupt discontinuation of fluoxetine: a Information regarding the use of Prozac while randomized, placebo-controlled study. American Psychiatric breastfeeding is limited. Prozac and its breakdown Association (abst book) 118, 1997. Nulman, I. and G. Koren. The safety of fluoxetine during pregnancy product, norfluoxetine, are found in breastmilk in and lactation. Teratology 53:304-308, 1996. amounts estimated to be 10 to 20 percent of the amount Nulman, I., et al . Neurodevelopment of children exposed to fluoxetine of the drug in the mother's blood. in utero: A prospective longitudinal study. Clinical Pharmacol. Ther. (abst). 59:159, 1996. Nulman, I., et al . Neurodevelopment of children exposed in utero to There are several case reports and a case series antidepressant drugs. NEJM 336(4): 258-262, 1997. regarding the use of Prozac during breastfeeding. Most Pastuszak, A., et al . Pregnancy outcome following first trimester exposure to fluoxetine (Prozac). JAMA 269(17): 2246-2248, 1993. reports found no adverse effects. However, in a small Rosa, F. Medicaid antidepressant pregnancy exposure outcomes. number of cases, irritability, vomiting, diarrhea, and/or Reproductive Toxicology 8(5), 1994. Strain, S.L. Fluoxetine-initiated ovulatory cycles in two clomiphene- decreased sleep were seen in newborns. These resistant women. JAm J Psychiatry 151(4): 620, 1994 Apr. symptoms were thought to be due to the mother's use Warnock, J.K. et al . Onset of menses in two adult patients with Prader- of Prozac while breastfeeding. One study noted a slight Willi syndrome treated with fluoxetine. Psychopharmacology Bulletin 31 (2): 239-42, 1995. decrease in weight gain; however, this decrease would Wisner, K.L., et al . Antidepressant treatment during breast-feeding. likely only be of significance if the infant's weight gain Am J Psychiatry153 (9): 1132-1137, 1996. were already of concern. Long-term studies on infants
