E-DRUG: Pregnancy Warning on Antidepressants
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For E-drug readers' convenience, I am copying a news item as published
in the 18th May New York Times regarding the risks associated with
antidepressant use in pregnancy. The item is based on an article in
Wednesday's JAMA.
With best wishes,
Shanthi Pal, M.Pharm PhD
Quality Assurance and Safety: Medicines
Department of Medicines Policy and Standards
World Health Organization
Geneva, Switzerland
Tel: + 41 22 791 1318
E-mail: pals@who.int
Website: http://www.who.int/medicines
"Pal, Shanthi N." <pals@who.int
[I have posted the abstract of the actual article below also. BS, Moderator]
Pregnancy Warning on Antidepressants
Top of Form 1
By THE ASSOCIATED PRESS
Published: May 18, 2005
CHICAGO, May 17 (AP) - Women who take Prozac or certain other
antidepressants late in pregnancy raise the risk that their babies will
suffer jitteriness, irritability and serious respiratory problems in
their first couple of weeks, researchers say.
Babies born to women taking antidepressants in the last three months of
pregnancy were three times more likely to develop drug-related symptoms
than those born to women who did not use the drugs or took them only in
early pregnancy, according to a University of Pittsburgh study that
pooled previous research.
The study was published in Wednesday's issue of The Journal of the
American Medical Association.
Most of the symptoms were mild and usually disappeared after about two
weeks, but some required hospitalization in intensive care, the
researchers said.
The drugs involved include Prozac, Paxil and other antidepressants known
as selective serotonin reuptake inhibitors or SSRI's, and also serotonin
norepinephrine reuptake inhibitors, which include Effexor.
Each year, at least 80,000 American women take the drugs during
pregnancy, the researchers estimated.
Serious respiratory problems develop in perhaps one out of 100 infants
born to these women, said Dr. Eydie Moses-Kolko, a psychiatrist who led
the study.
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Neonatal Signs After Late In Utero Exposure to Serotonin Reuptake Inhibitors
JAMA. 2005;293:2372-2383.
http://jama.ama-assn.org/cgi/content/short/293/19/2372
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
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).