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Use of Psychoactive Medication During Pregnancy and Possible Effects on the Fetus and Newborn

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Use of Psychoactive Medication During Pregnancy and Possible Effects on the Fetus and Newborn AMERICAN ACADEMY OF PEDIATRICS Committee on Drugs Use of Psychoactive Medication During Pregnancy and Possible Effects on the Fetus and Newborn ABSTRACT. Psychoactive drugs are those psychother- ins; history of miscarriages and stillbirths; genetic apeutic drugs used to modify emotions and behavior in history; use of multiple drugs including nonprescrip- the treatment of psychiatric illnesses. This statement will tion drugs; gestational age at time of drug exposure; limit its scope to drug selection guidelines for those compliance; total dose; and the effects of the psychi- psychoactive agents used during pregnancy for preven- atric illness or other illnesses present. Our knowl- tion or treatment of the following common psychiatric edge will remain limited because prospective, ran- disorders: schizophrenia, major depression, bipolar dis- order, panic disorder, and obsessive-compulsive disor- domized, and well-controlled investigational studies der. The statement assumes that pharmacologic therapy on the risks of exposure to psychoactive drugs dur- 19 is needed to manage the psychiatric disorder. This deci- ing pregnancy are neither feasible nor ethical. sion requires thoughtful psychiatric and obstetric advice. When psychoactive drugs are medically indicated during pregnancy, this exposure could provide an opportunity to conduct prospectively controlled com- ABBREVIATION. FDA, Food and Drug Administration. parisons of the fetal effects of these drugs to carefully matched controls. Recent prospective, well-controlled he primary literature on use of these drugs epidemiologic studies have lessened, to some extent, during pregnancy has been extensively re- the concerns that lithium and fluoxetine are teratogen- Tviewed in the past decade.1–13 The serious con- ic.20–22 Guidelines published in 199623 for the use of sequences to the mother and fetus of not using these anticonvulsants during pregnancy are available. drugs during pregnancy also have been ad- With these limitations in mind, this statement pro- dressed.4,6,8,11,13 The Food and Drug Administration vides literature-based guidelines to assist physicians (FDA) classifies drugs for teratogenic risk as shown with appropriate drug selection for women who con- in Table 1.14,15 Friedman et al16 and the Public Affairs template pregnancy or are pregnant and who have Committee of the Teratology Society17 have chal- psychiatric disorders that require drug treatment. lenged these “Use-in-Pregnancy Ratings.” These au- Information about the effects of those drugs on the thors believe that the ratings do not provide suffi- fetus and newborn is also provided. Detailed advice cient useful therapeutic guidance to physicians and regarding drug selection is provided in the accompa- that the default assignment of agents to FDA cate- nying tables. The determination of which drug treat- gory C is misleading to many practitioners who con- ment to use entails the following: 1) physician and sider this rating to indicate some degree of risk (ie, informed patient (family) risk–benefit analysis; 2) an more risk than that of category B) rather than a lack assessment of risk for the fetus and the breastfed new- of information from studies in humans. They recom- born24; 3) consideration of skip-generation or first filial mend FDA ratings be replaced by narrative state- (F1) generation risk (eg, epidemiologic evidence of the ments that summarize and interpret available data development of vaginal cancer in the offspring of a regarding hazards of developmental toxicity and mother exposed to diethylstilbestrol)25; and 4) the fam- provide estimates of teratogenic risk. The Committee ily medical history, especially a history of psychoactive on Drugs is encouraged to note that an FDA subcom- drug treatment that was effective. mittee is actively working on this issue assisted by the Office of Research on Women’s Health of the BENEFITS AND RISKS OF DRUG TREATMENT National Institutes of Health.18 Because of the potential for teratogenesis and other Estimates of risk for drugs used during pregnancy adverse events in the fetus or newborn, varying de- are derived largely from case reports or retrospective grees of concern exist when any drug is prescribed cohort epidemiologic studies. These types of studies during pregnancy. Avoidance of pregnancy and are often biased or flawed because of possible report- avoidance of drug therapy during pregnancy are ing bias and the many confounding variables, such commonly suggested strategies to prevent fetal drug as nutritional and health status; maternal age; use of exposure. However, these strategies are often not alcohol, tobacco, or illicit drugs; environmental tox- possible. It frequently becomes necessary to contem- plate pharmacotherapy following counseling of a pregnant woman who has a serious psychiatric ill- The recommendations in this statement do not indicate an exclusive course ness, because the benefit of appropriate psychoactive of treatment or serve as a standard of medical care. Variations, taking into 26 account individual circumstances, may be appropriate. drug treatment has been clearly established. PEDIATRICS (ISSN 0031 4005). Copyright © 2000 by the American Acad- Drug treatment is indicated if psychotherapy is emy of Pediatrics. inadequate or inappropriate for the patient’s severity of 880 PEDIATRICS Vol. 105Downloaded No. 4 April from www.aappublications.org/news 2000 by guest on September 28, 2021 TABLE 1. FDA Use-in-Pregnancy Ratings onate include: 1) structural malformations, 2) acute Category Interpretation neonatal effects including intoxication and neonatal abstinence syndromes, 3) intrauterine fetal death, 4) A Controlled studies show no risk. Adequate, well- controlled studies in pregnant women have failed to altered fetal growth, and 5) neurobehavioral terato- demonstrate risk to the fetus. genicity. Neurobehavioral teratogenicity encom- B No evidence of risk in humans. Either animal findings passes long-term central nervous system defects that show risk, but human findings do not, or if no result in delayed behavioral maturation, impaired adequate human studies have been done, animal problem solving, and impaired learning.27 Physical findings are negative. C Risk cannot be ruled out. Human studies are lacking, malformations do not necessarily accompany the and animal studies are either positive for fetal risk or functional deficits. Chronic in utero exposure to lacking as well. However, potential benefits may drugs may result in intoxication or tolerance postna- justify the potential risk. tally.28 Neonatal drug withdrawal symptoms may D Positive evidence of risk. Investigational or 29 postmarketing data show risk to the fetus. occur when drug exposure ceases at birth. Specific Nevertheless, potential benefits may outweigh the and supportive therapy may be required if the new- potential risk. born displays signs of continued drug effects or with- X Contraindicated in pregnancy. Studies in animals or drawal. Long-term developmental and neurologic fol- humans, or investigational or postmarketing reports low-up is appropriate, including consideration for have shown fetal risk that clearly outweighs any possible benefit to the patient. referral to centers for national databases (eg, Teratology Information Services and Motherisk Program). illness. Once a decision to offer pharmacotherapy is GENERAL DOSING RECOMMENDATIONS made, important factors in drug selection for the Before it is possible to predict potential adverse mother include efficacy of the drugs available, the an- events based on pharmacokinetic data, considerable ticipated response of the individual patient, and the pharmacokinetic studies will be required in infants overall toxicity profile of the drug for the mother and and children. Adverse drug events are often linked fetus. to the pharmacokinetic variations in maternal, pla- Potential adverse effects for the fetus and the ne- cental, fetal, or neonatal drug absorption, distribu- TABLE 2. Treatment of Schizophrenia During Pregnancy Generic Name Relative Remarks Trade Name Potency* Risperidone 1 (High) Neonatal effects: Signs at delivery associated with exposure to the low-potency group include Risperdal tachycardia, gastrointestinal dysfunction, sedation, and hypotension. Depending on the Fluphenazine 2 extent of exposure, these reactions seldom persist for more than a few days.48 Permatitil Extrapyramidal signs that are associated with large maternal doses of high-potency Prolixin antipsychotics include hyperactivity, hyperactive deep tendon reflexes, motor restlessness, Olanzapine † and abnormal movements.28 These may persist for several months. Additional signs Zyprexa reflecting extrapyramidal activity include tremors, posturing and flapping of the hands, Haloperidol 2 increased muscle tone, unusually vigorous rooting and sucking, arching of the back, and Haldol shrill crying. Pimozide 2 Teratogenic effects: Haloperidol, perphenazine, thiothixene and trifluoperazine do not have a Orap known teratogenic action based on either animal data or limited surveillance data in Thiothixene 5 humans. The lower potency agents, particularly chlorpromazine, have been cited as being Navane teratogenic by some authors49; however, surveillance data do not support this finding for Trifluoroperazine 5 chlorpromazine, prochlorperazine, triflupromazine50 or thioridazine.51 Most antipsychotic Stealzine agents are not known to cause structural birth defects. Studies in animals suggest that Perphenazine 10 neurobehavioral abnormalities occur.2,52–56
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