 |
|
Neonatal Signs After Late In Utero Exposure to Serotonin Reuptake Inhibitors
Literature Review and Implications for Clinical Applications
Eydie L. Moses-Kolko, MD;
Debra Bogen, MD;
James Perel, PhD;
Amy Bregar;
Kathleen Uhl, MD;
Bob Levin, MD;
Katherine L. Wisner, MD, MS
JAMA. 2005;293:2372-2383.
Context A neonatal behavioral syndrome linked to in utero serotonin reuptake inhibitor (SRI) exposure during the last trimester of pregnancy has been identified. The US Food and Drug Administration (FDA) and drug manufacturers have recently agreed to a class labeling change for SRIs, which include selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs), to include information about potential adverse events in neonates exposed in utero. Integration of data about the neonatal behavioral syndrome into the management of pregnancy in women who take SRIs is a current challenge for physicians.
Objectives To review evidence regarding the SRI-related neonatal syndrome and to help clinicians guide their patients in a risk-benefit decision-making process.
Data Sources We searched MEDLINE (1966–February 2005) and PsycINFO (1974–February 2005). All articles related to neonatal signs after in utero SRI exposure were acquired, as well as unpublished data on this topic from the FDA advisory committee meeting of June 2004. References cited in case reports and studies were reviewed. Foreign-language literature was included and translated to English.
Study Selection and Data Extraction Studies were included if they had clearly identified maternal SRI exposure for a minimum of the final trimester of pregnancy through delivery and assessed neonatal outcomes. We identified 13 case reports describing a total of 18 cases. Nine cohort studies met criteria. When not included in the published article, relative risks and 95% confidence intervals (CIs) were computed from raw data and summary risk ratios and 95% CIs were determined with Mantel-Haenszel estimates.
Data Synthesis Compared with early gestational SRI exposure or no exposure, late SRI exposure carries an overall risk ratio of 3.0 (95% CI, 2.0-4.4) for a neonatal behavioral syndrome. The most SRI-related neonatal case reports involved fluoxetine and paroxetine exposures. Neonates primarily display central nervous system, motor, respiratory, and gastrointestinal signs that are usually mild and disappear by 2 weeks of age. Medical management has consisted primarily of supportive care in special care nurseries. A severe syndrome that consists of seizures, dehydration, excessive weight loss, hyperpyrexia, or intubation is rare in term infants (1/313 quantifiable cases). There have been no reported neonatal deaths attributable to neonatal SRI exposure.
Conclusions Available evidence indicates that in utero exposure to SRIs during the last trimester through delivery may result in a self-limited neonatal behavioral syndrome that can be managed with supportive care. The risks and benefits of discontinuing an SRI during pregnancy need to be carefully weighed for each individual patient. Development and validation of assessment methods and clinical management strategies are critical to advancing this research.
Author Affiliations: Departments of Psychiatry (Drs Moses-Kolko, Perel, and Wisner), Pediatrics (Drs Bogen and Wisner), Clinical Pharmacology (Dr Perel), and Obstetrics and Gynecology (Dr Wisner), University of Pittsburgh School of Medicine, Pittsburgh, Pa; Princeton University, Princeton, New Jersey (Ms Bregar); and Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Md (Drs Uhl and Levin).
RELATED LETTERS
Neonatal Signs After In Utero Exposure to Selective Serotonin Reuptake Inhibitors
Bennett A. Kaye and Judith Weinstein
JAMA. 2005;294(18):2299-2300.
EXTRACT
| FULL TEXT
Neonatal Signs After In Utero Exposure to Selective Serotonin Reuptake Inhibitors
Bennett Lavenstein
JAMA. 2005;294(18):2300.
EXTRACT
| FULL TEXT
Neonatal Signs After In Utero Exposure to Selective Serotonin Reuptake Inhibitors—Reply
Eydie L. Moses-Kolko, Debra Bogen, James Perel, Katherine L. Wisner, Amy Bregar, Kathleen Uhl, and Bob Levin
JAMA. 2005;294(18):2300-2301.
EXTRACT
| FULL TEXT
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Poor Neonatal Adaptation After in Utero Exposure to Duloxetine
EYAL and YAEGER
Am. J. Psychiatry 2008;165:651-651.
FULL TEXT
Effects of timing and duration of gestational exposure to serotonin reuptake inhibitor antidepressants: population-based study
Oberlander et al.
Br. J. Psychiatry 2008;192:338-343.
ABSTRACT
| FULL TEXT
Escitalopram Therapy for Major Depression and Anxiety Disorders
Baldwin et al.
The Annals of Pharmacotherapy 2007;41:1583-1592.
ABSTRACT
| FULL TEXT
Antenatal Depression: Navigating the Treatment Dilemmas
Freeman
Am. J. Psychiatry 2007;164:1162-1165.
FULL TEXT
Effects of Antenatal Depression and Antidepressant Treatment on Gestational Age at Birth and Risk of Preterm Birth
Suri et al.
Am. J. Psychiatry 2007;164:1206-1213.
ABSTRACT
| FULL TEXT
Neonatal Risks of Maternal Treatment With Mood Stabilizers--Reply
Oberlander et al.
Arch Gen Psychiatry 2007;64:867-868.
FULL TEXT
Externalizing and Attentional Behaviors in Children of Depressed Mothers Treated With a Selective Serotonin Reuptake Inhibitor Antidepressant During Pregnancy
Oberlander et al.
Arch Pediatr Adolesc Med 2007;161:22-29.
ABSTRACT
| FULL TEXT
Effects of Selective Serotonin Reuptake Inhibitors and Venlafaxine During Pregnancy in Term and Preterm Neonates
Ferreira et al.
Pediatrics 2007;119:52-59.
ABSTRACT
| FULL TEXT
Paroxetine Use During Pregnancy: Is it Safe?
Thormahlen
The Annals of Pharmacotherapy 2006;40:1834-1837.
ABSTRACT
| FULL TEXT
Neonatal outcomes after prenatal exposure to selective serotonin reuptake inhibitor antidepressants and maternal depression using population-based linked health data.
Oberlander et al.
Arch Gen Psychiatry 2006;63:898-906.
ABSTRACT
| FULL TEXT
Treatment With Selective Serotonin Reuptake Inhibitors During Pregnancy: Deceleration of Weight Gain Because of Depression or Drug?
Bodnar et al.
Am. J. Psychiatry 2006;163:986-991.
FULL TEXT
Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn
Chambers et al.
NEJM 2006;354:579-587.
ABSTRACT
| FULL TEXT
Depressing Observations on the Use of Selective Serotonin-Reuptake Inhibitors during Pregnancy
Mills
NEJM 2006;354:636-638.
FULL TEXT
Other articles noted
Evid. Based Med. 2006;11:31-32.
FULL TEXT
Relapse of Major Depression During Pregnancy in Women Who Maintain or Discontinue Antidepressant Treatment
Cohen et al.
JAMA 2006;295:499-507.
ABSTRACT
| FULL TEXT
Neonatal Signs After In Utero Exposure to Selective Serotonin Reuptake Inhibitors
Lavenstein
JAMA 2005;294:2300-2300.
FULL TEXT
Neonatal Signs After In Utero Exposure to Selective Serotonin Reuptake Inhibitors
Kaye and Weinstein
JAMA 2005;294:2299-2300.
FULL TEXT
Journal Watch
Arch. Dis. Child. 2005;90:980-981.
FULL TEXT
Neonatal Behavioral Complications from SRI Exposure: Fairly Common, Rarely Serious
JWatch Psychiatry 2005;2005:12-12.
FULL TEXT
Short cuts: What's new in the other general journals
Tonks
BMJ 2005;330:1231-1232.
FULL TEXT
Neonatal Behavioral Complications from SRI Exposure: Fairly Common, Rarely Serious
JWatch General 2005;2005:4-4.
FULL TEXT
|
