Sekiz ülkeden 18 İlaç Kurumu Doğum Kusurlarına Neden Olan Antidepresanlara İlişkin Düzenleyici Uyarıları – Sekiz ülkeden, kalp ve akciğer bozuklukları, pulmoner hipertansiyon, erken doğumlar, nefes almada zorluk, maviye dönme, nöbetler, vücut sıcaklığının değişmesi, beslenme sorunları, kusma, düşük kan şekeri, gevşeklik, sertlik, titreme.

There have been 18 studies in eight countries (United States, United Kingdom, Australia, Canada, Netherlands, Finland, Denmark and Sweden), which found a connection between antidepressants and birth defects listed below:

Nordic Countries, January 12, 2012: A study published in the British Medical Journal looked at 1.6 million infants born between 1996-2007. The authors found that mothers who used SSRIs late in pregnancy increased the risk of their child being born with a birth defect effecting breathing, known as persistent pulmonary hypertension. This increased risk was more than two folds.   Source: Helle Kieler, Miia Artama, Anders Engeland, Orjan Ericsson, Kari Furu, Mika Gissler, Rikke Beck Nielsen, Mette Norgaard, Olof Stephansson, Unnur Valdimarsdottir, Helga Zoega, Bengt Haglund, “Selective serotonin reuptake inhibitors during pregnancy and risk of persistent pulmonary hypertension in the newborn: population based cohort study from the five Nordic countries,” British Medical Journal, Vol. 344, Jan 12, 2012.

Finland, July 01, 2011: The journal Obstetrics & Gynecology published a Finnish population-based study of 635,583 births, where 6,976 (1.1%) of the fetuses were exposed to SSRIs (newer antidepressants) during their first trimester. The authors found “that exposure to fluoxetine (Prozac) and Paroxetine (Paxil) in early pregnancy is associated with a small but established risk of specific cardiovascular anomalies [heart defects]…”   Source: Heli Malm, MD, PhD, Miia Artama, MSc, PhD, Mika Gissler, MSocSc, PhD, and Annukka Ritvanen, MD, “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies,” Obstetrics & Gynecology, Vol. 118, No. 1, July 2011.

Denmark, June 23, 2010: A study in BioMed Central, Ltd., showed how the prescribing of psychotropic drugs in infants is rapidly increasing. In attempts to curb the use of these drugs, regulatory authorities have issued various warnings about risks associated with use of these products in childhood. This team of researchers analyzed data submitted to a national adverse drug reactions (ADR) database to categorize ADRs reported for psychiatric drugs in the Danish pediatric population. They found that almost 20% of psychotropic ADRs were reported for children from birth up to 2 years of age and one half of ADRs were reported in adolescents. The authors concluded that, “The high number of serious ADRs reported for psychotropic medicines in the pediatric population should be a concern for health care professionals and physicians. Considering the higher number of birth defects being reported greater care has to be given while prescribing these drugs for pregnant women.”   Source: Lise Aagaard and Ebba H Hansen, “Adverse drug reactions from psychotropic medicines in the paediatric population: analysis of reports to the Danish Medicines Agency over a decade,” BioMed Central Ltd., vol. 3, no. 176, June 23, 2010.

Australia, May 01, 2010: A study in Australian and New Zealand Journal of Psychiatry looked at whether newborn outcomes, including age at birth, growth at birth and then at 1 month, were altered by exposure to antidepressants during pregnancy. They found that antidepressant exposure during pregnancy resulted in an eightfold increase in chance of being born premature, and with a smaller birth weight. This association was not found with depressed mothers. In addition, at 1 month in age, the difference in weight in the exposed group became significantly greater then those not exposed to antidepressants.  Source: Andrew J. Lewis, et al, “Neonatal growth outcomes at birth and one month postpartum following in utero exposure to Antidepressant medication,” Australian and New Zealand Journal of Psychiatry, Vol. 44, No. 5, May 2010.

Canada, April 26, 2010: The American Journal of Obstetrics and Gynecology published a study that researched whether maternal bupropion (an antidepressant) treatment in early pregnancy is associated with birth heart defects in the infant. They found that mother’s of infants with left outflow tract heart defects were more likely to have reported taking bupropion. The authors concluded that there is an association between early pregnancy bupropion use and left outflow tract heart defects.   Source: Alwan S, Reefhuis J, Botto LD, et al., “Maternal use of bupropion and risk for congenital heart defects.” American Journal of Obstetrics and Gynecology, Volume 203, Issue 1 , Pages 52.e1-52.e6, July 2010.

Denmark, March 01, 2010: The journal Pediatrics published a study that investigated the possible association between antidepressant exposure (including Paxil) to the fetus during pregnancy and normal milestone developments at 6 and 19 months. Their concluding research found that exposure to antidepressants affected fetal brain development.   Source: Lars Henning Pedersen, MD, et al., “Fetal Exposure to Antidepressants and Normal Milestone Development at 6 and 19 Months of Age,” Pediatrics, Vol. 125, No. 3, March 3, 2010.

Sweden, January 05, 2010: Authors of a study published in Psychological Medicine investigated possible adverse effects of the use of antidepressant medication during pregnancy. They reviewed 14,821 women from the Swedish Medical Birth Register. The researchers found that there was an association between antidepressant treatment and many pregnancy complications, notably after tricyclic antidepressant use. An association between use of Paroxetine (Paxil) and birth heart defects and urinary tube defects was also found. The authors concluded that women using antidepressants during pregnancy and their newborns have an increase in health issues.   Source: M. Reis, and B. Kallen, “Delivery outcome after maternal use of antidepressant drugs in pregnancy: an update using Swedish data,” The Psychological Medicine, 1-11, [Epub ahead of print], Jan. 5, 2010.

United States, January 01, 2010: A study published in the Current Drug Delivery researched the “under evaluated” impact of antidepressant use during pregnancy on the risk of spontaneous abortion. After reviewing the data collected, they said the information suggests fetal exposure to antidepressants, especially Paroxetine (Paxil) and venlafaxine (Effexor), can lead to spontaneous abortion.   Source: Broy, Perrine and Berard, Anick., “Gestational Exposure to Antidepressants and the Risk of Spontaneous Abortion: A Review,” Current Drug Delivery, Vol. 7, No. 1, January 2010.

United States, December 01, 2009: A study in the American Journal of Obstetrics & Gynecology looked at the effects of psychiatric drugs taken during pregnancy on fetal outcomes. It found that Selective serotonin receptor inhibitors (SSRIs – newer antidepressants) were associated with preterm deliveries when women started treatment after the first trimester. The researchers recommend more studies about risks and benefits of psychotropic medication use during pregnancy.   Source: Ronit Calderon-Margalit, MD, MPH, et al., “Risk of preterm delivery and other adverse perinatal outcomes in relation to maternal use of psychotropic medications during pregnancy” American Journal of Obstetrics & Gynecology, Vol. 201, Iss. 6, Page 579, December 2009.

United Kingdom, September 23, 2009: A study published in the British Medical Journal reviewed the chances of SSRIs (newer antidepressants) causing birth defects when taken during pregnancy. The authors found a significant increase in risk of septal (the muscle wall that divides the heart chambers) heart defects among children who’s mothers took SSRIs during pregnancy, particularly with sertraline and citalopram. This risk nearly doubled when more then one SSRI was taken.   Source: Lars Henning Pedersen, et al, “Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study,” British Medical Journal, Vol. 339, September 23, 2009.

Canada, September 01, 2009: The journal Current Drug Safety published a study that found when pregnant women used Paroxetine (Paxil) during the stage in pregnancy when their baby’s organs are being developed, there was a connection to the increased risk of heart malformations.   Source: Simoncelli M, Martin BZ, Brard A, “Antidepressant Use during Pregnancy: A Critical Systematic Review of the Literature,” Current Drug Safety, September 1, 2009.

Netherlands, August 14, 2009: The journal BJOG: An International Journal of Obstetrics & Gynaecology published a study that found children of mothers who used antidepressants during pregnancy showed increased healthcare use during the first year of life, independent of the mother’s healthcare use, and had an increased risk of major cardiac interventions such as cardiovascular surgery or heart catheterization in early childhood.   Source: TF Ververs, et al., “Association between Antidepressant drug use during pregnancy and child healthcare utilization,” BJOG: An International Journal of Obstetrics & Gynaecology, August 14, 2009.

United States, October 24, 2007: A study presented at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry by Sheila Marcus, MD, found that babies born to mothers who take antidepressant drugs during pregnancy have high levels of cortisol (primary stress hormone) in cord-blood at birth, and their mothers are more likely to experience delivery complications.  Source: Sheila Marcus, M.D., “Antidepressant Medication and Depression Status: Impact on Neonatal Outcomes,” presented at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry, October 24, 2007.

United States, June 28, 2007: A study published in the New England Journal of Medicine found that infants born to women taking commonly prescribed newer antidepressants during the first trimester of their pregnancies have a slightly higher risk of life-threatening birth defects.   Source: Carol Louik, Sc.D., et al., “First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects,” New England Journal of Medicine, Vol. 356, No. 26, June 28, 2007.

Canada, December 29, 2006: A new study published in Birth Defects Research Part B: Developmental and Reproductive Toxicology on Paxil, found that Paxil and other antidepressant use in pregnant women increased the possibility that their babies would be born with birth defects.   Source: Roman Bystrianyk, “Paroxetine (Paxil or Paxil CR) can more than triple major cardiac birth Defects,” Health Sentinel, December 29, 2006 citing: Birth Defects Research Part B: Developmental and Reproductive Toxicology, December 2006.

Denmark, November 01, 2006: An Epidemiology study found that pregnant women who took newer antidepressants were more likely to have babies with birth defects than mothers who didn’t take these drugs.   Source: Wogelius, Pia, Norgaard, Mette, Gislum, Mette, Pedersen, Lars, Munk, Estrid, et al., “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations,” Epidemiology, Vol. 17, No. 6, November 2006.

Finland, July 15, 2003: A Finnish study published in the Archives of General Psychiatry found that infants whose mothers took newer antidepressants during pregnancy could suffer neurological problems during their first week of life. The symptoms included tremors, restlessness and rigidity.  Source: “Newer Antidepressants Can Harm Newborns,” Connecticut Post, July 15, 2003.

United States, May 01, 1993: A study published in the Journal of the American Medical Association found that out of 117 mother who took fluoxetine (Prozac) during the first trimester had a 14.8% risk of miscarriage compared to 7.8% in mothers not exposed to fluoxetine or older antidepressants. There were 19 spontaneous abortions and 13 abnormalities, including heart and small intestine defects in the Prozac group. One baby was born with clubfeet, and a second with a congenital dislocation of the hip. In comparison, there were only 10 spontaneous abortions and 4 anomalies in the non-drug group.   Source: Anne Pastuszak, BSc, et al., “Pregnancy Outcome Following First-Trimester Exposure to Fluoxetine (Prozac),” Journal of The American Medical Association, Vol. 269, No. 17, May 5, 1993.