To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Nursing Mothers With Depression Can Safely Take Paxil, Study Shows URL: http://www.pslgroup.com/dg/16091A.htm Doctor's Guide February 2, 2000
ATLANTA, GA -- February 2, 2000 -- A study with Paxil(R) (paroxetine HCI, SmithKline Beecham), published this month in the American Journal of Psychiatry, showed that breast-fed infants of mothers taking the antidepressant had no detectable traces of the medication in their blood and experienced no adverse events as reported by either the parents or pediatricians. Paxil is a selective serotonin reuptake inhibitor (SSRI) that is used to treat a range of mood and anxiety disorders. Paxil was recently approved by the U.S. Food and Drug Administration as the first and only drug indicated to treat social anxiety disorder. It is also indicated for depression, panic disorder and obsessive compulsive disorder. "Due to the increased occurrence of mood and anxiety disorders during child-bearing years, it is imperative that we continue to research and make treatment options such as Paxil available for mothers who want the opportunity and benefit of breast-feeding their children," said lead clinical investigator, Zachary N. Stowe, M.D., director of Emory University School of Medicine's Pregnancy and Postpartum Mood Disorders Program. "This study provides compelling data that Paxil is a viable treatment option for mothers who would like to continue breast-feeding." Results from this unique study provide the first detailed characterization of Paxil excretion into human breast milk as well as extensive information on infant exposure during breast-feeding. Participants in the study included postpartum women treated with Paxil (10-50 mg/day for >10 days) and their newborn infants. Blood samples were obtained from all mothers within two to five hours after the daily Paxil dose and from the infants within one to five hours after nursing. The majority of the infants were fully breast-fed with no supplemental nutrition. The key finding was that all infant blood samples had no detectable concentrations of the medication. Furthermore, the definition for detection (<2 ng/ml) was more stringent than has been reported in studies of breast milk and other antidepressants. Although low Paxil concentrations were found in the breast milk (similar to or less than other antidepressants), exposure to the infant was minimal. The parents involved in the study did not report any change in infant behavior, disposition, sleep, activity, or bowel movements, and also reported that their pediatrician did not communicate any concerns in infant growth or development. Breast milk provides a superior course of nutrients and protection against infection, as well as acute and chronic illnesses. The American Academy of Pediatrics (AAP) and the American Dietetic Association support breast milk as the ideal form of nutrition over formula and milk. Numerous studies have also demonstrated that breast milk may prevent sudden infant death syndrome, type 1 diabetes mellitus and allergies. The AAP recommends that breast-feeding begin at birth and continue for at least 12 months. Equally convincing, the data on untreated depression in mothers has demonstrated deleterious effects on infant attachment (e.g., bonding) and development. These data reinforce the clear, unequivocal need to treat depression when it affects mothers. "It is important that the benefits of the medication for the depressed mother, as well as the benefits of breast-feeding for the infant, be considered by the practitioner and patient," said Dr. Stowe. "The data from this study is reassuring to both physicians and these mothers who want to breast-feed." Related Links: Paxil (paroxetine HCI) and SmithKline Beecham. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.