There have been 30 studies in nine countries (Canada, Netherlands, Denmark, Finland, Iceland, Sweden, Norway, United States and United Kingdom) on Zoloft. These studies are as follows:
Canada, March 21, 2012: British Journal of Clinical Pharmacology published a study where the authors reviewed 1,216 women with pregnancy-induced hypertension (high blood pressure) and no history of hypertension. They found that women using antidepressants (including Zoloft) during pregnancy were at increased risk of pregnancy-induced hypertension, especially those on SSRIs. Source: Mary A De Vera Ph, Anick Berard PhD, FISPE, “Antidepressant Use During Pregnancy and the Risk of Pregnancy Induced Hypertension,” British Journal of Clinical Pharmacology, March 21, 2012.
Netherlands, January 18, 2012: The British Journal of Psychiatry published a study that looked at daily drug use and daily falls recorded in 248 nursing home residents with dementia from 2006 until 2008. Even at low doses, SSRIs (newer antidepressants, such as Zoloft) were associated with increased risk of an injurious fall in nursing home residents with dementia and the use of an SSRI in combination with a hypnotic or sedative further increased the risk. Source: Carolyn S. Sterke MSc, Gijsbertus Ziere MD, PhD, Ed F. van Beeck MD, PhD, Caspar W. N. Looman MSc, Tischa J. M. van der Cammen MD, PhD, “Dose-response relationship between Selective Serotonin Reuptake Inhibitors and Injurious Falls: A study in Nursing Home Residents with Dementia,” British Journal of Clinical Pharmacology, January 18, 2012.
Nordic Countries, January 12, 2012: A study published in the British Medical Journal looked at 1.6 million infants born between 1996-2007 in Nordic Countries: Denmark, Finland, Iceland, Sweden, Norway. The authors found that mothers who used SSRIs (newer antidepressants, such as Zoloft) late in pregnancy increased the risk of their child being born with a birth defect effecting breathing, know 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, January 12, 2012.
United States, December 01, 2011: The Journal of Clinical Psychiatry published a study where researchers conducted a trial from Nov 2001 to June 2007, with 156 patients who were treated for 16 weeks with either psychotherapy, sertraline (Zoloft) (and if that failed, they were switched to venlafaxine), or a placebo. The authors concluded that this trial showed that both active treatments failed to be better than placebo. Source: Jacques P. Barber, PhD; Marna S. Barrett, PhD; Robert Gallop, PhD; Moira A. Rynn, MD; and Karl Rickels, MD, “Short-Term Dynamic Psychotherapy Versus Pharmacotherapy for Major Depressive Disorder: A Randomized, Placebo-Controlled Trial,” Journal of Clinical Psychiatry, 73(1):66-67, December 2011.
United Kingdom, August 02, 2011: The British Medical Journal published a study where the authors assessed the risk of several side effects of antidepressants (such a Zoloft) in the elderly, and how these risks are affected by length of use and dosage. They took data from over 54,000 UK patients who have received at least one prescription of an antidepressant. They found that, “All classes of antidepressant drug were associated with significantly increased risks of mortality, attempted suicide/self harm, falls, fractures, and upper gastrointestinal bleeding compared with when these drugs were not being used.” And surprisingly, SSRIs, compared to older antidepressants, had higher rates of many of the previously mentioned risks. Source: Carol Coupland, Paula Dhiman, Richard Morriss, Antony Arthur, Garry Barton, Julia Hippisley-Cox, “Antidepressant use and risk of adverse outcomes in older people: population based cohort study,” British Medical Journal, Vol. 343, August 2, 2011.
United Kingdom, July 18, 2011: The Lancet published a study where the authors took the two most commonly prescirbed drugs for depression, sertraline (Zoloft) and mirtazapine (Remeron), and compared it with a placebo. In treating depression in dementia patients for 39 weeks, the authors did not find any benefit of using these drugs over placebo, and recommend use of these antidepressants be reconsidered. “Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimer’s disease should be reconsidered.” Source: Sube Banerjee, et al., “Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial” The Lancet, Vol. 378, p 403-411, 30 July 2011.
United States, December 01, 2010: The authors of a study in PLoS One took the Food and Drug Administration’s Adverse Event Reporting System data, and extracted all “serious adverse event” reports for drugs with 200 or more cases received from 2004 through September 2009. They identified 484 drugs, which accounted for 780,169 serious adverse event reports of all kinds, including 1,937 cases meeting their violence criteria. Of the 484 drugs identified, 31 drugs were disproportionately associated with violence. These drugs, accounting for 79% of all the violence cases, included 11 antidepressants (including Zoloft), 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The specific cases of violence included: homicide, physical assaults, cases indicating physical abuse, homicidal ideation, and cases described as violence-relates symptoms. The authors concluded, “These data provide new evidence that acts of violence towards others are a genuine and serious adverse drug event that is associated with a relatively small group of drugs. Source: Thomas J. Moore, Joseph Glenmullen, Curt D. Furbert, “Prescription Drugs Associated with Reports of Violence Towards Others,” Public Library of Science ONE, Vol. 5, Iss. 12, December 2010.
United States, August 24, 2010: A study was published in the Journal of the American College of Cardiology that found that treatment with the antidepressant sertraline (Zoloft) “compared with placebo did not provide greater reduction in depression… among patients with heart failure and depression.” Source: Christopher M. O’Connor, Wei Jiang, Maragatha Kuchibhatla, Susan G. Silva, Michael S. Cuffe, Dwayne D. Callwood, Bosh Zakhary, Wendy Gattis Stough, Rebekka M. Arias, Sarah K. Rivelli, and Ranga Krishnan, “Safety and Efficacy of Sertraline for Depression in Patients With Heart Failure,” Journal of the American College of Cardiology, August 24, 2010, 56:692-69.
Denmark, June 23, 2010: A study in BioMed Central 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 (including reports for Zoloft) 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.
Canada, May 01, 2010: The Archives of General Psychiatry published a study that compared the risk of suicide and suicide attempts associated with specific antidepressants. After reviewing Canadian health care records, they found equal event rates across antidepressant agents (such as Zoloft), which supports the U.S. FDA’s decision to treat all antidepressants alike in their advisory on antidepressants increasing the risk of suicidal thoughts and behavior. Source: Sebastian Schneeweiss, MD, et al., “Variation in the Risk of Suicide Attempts and Completed Suicides by Antidepressant Agent in Adults,” Archives of General Psychiatry, Vol. 67, No. 5, May 2010.
Canada, April 12, 2010: A study published in Pediatrics was done on 20,906 children from British Columbia (BC), who were new users of antidepressants, of which 16,777 (80%) had never used an antidepressant before. The children were aged 10 to 18, and had a recorded diagnosis of depression. During the 9-year study period, the suicide risk among all BC kids aged 13 to 17 averaged 0.052 suicide deaths per 1,000 people. The rate of suicides that the authors observed after initiation of antidepressant use was 5 times higher. The authors concluded: “Our analysis supports the decision of the Food and Drug Administration to include all antidepressants [such as Zoloft] in the black box warning regarding increased suicidality risk for children and adolescents initiating use of antidepressants.” Source: Sebastian Schneeweiss, et al., “Comparative Safety of Antidepressant Agents for Children and Adolescents Regarding Suicidal Acts,” Pediatrics, April 12, 2010.
Denmark, March 01, 2010: The journal Pediatrics published a study that investigated the possible association between antidepressant exposure (including Zoloft) to the fetus during pregnancy and normal milestone developments at 6 and 19 months. Their 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.
United Kingdom, September 23, 2009: A study published in the British Medical Journal reviewed the chances of SSRIs (such as Zoloft) 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.
United States, June 01, 2009: The Journal of Clinical Psychopharmacology published a study that aimed to calculate sexual dysfunction (SD) caused by antidepressants (like Zoloft). The authors concluded, “Treatment-emergent SD is a frequent adverse effect [of some antidepressants]…” Source: Serretti, A., Chiesa A., “Treatment-emergent Sexual Dysfunction Related to Antidepressants: A Meta-Analysis,” The Journal of Clinical Psychopharmacology, Vol. 29, Is. 3, pp 259-66, June 2009.
United States, October 08, 2007: Alimentary Pharmacology & Therapeutics published a study that found that newer antidepressants may double the risk of gastrointestinal (GI) bleeding. They found patients taking newer antidepressants, such as Zoloft, were nearly twice as likely to develop upper GI bleeding than patients not taking the drugs. When the patients also took “non-steroidal anti-inflammatory drugs”, such as Ibuprofen, the risk of upper gastrointestinal bleeding was six times higher than in patients taking neither medication. Source: “Study: Antidepressants Double Stomach Bleeding Risk, Mixing with painkillers Increase Six Times,” FoxNews.com, October 9, 2007.
United States, August 01, 2007: The American Journal of Psychiatry published a study, which found that using antidepressants (such as Zoloft), not depression, during pregnancy was associated with premature births. Source: Rita Suri, M.D, et al., “Effects of Antenatal Depression and Antidepressant Treatment on Gestational Age at Birth and Rick of Preterm Birth,” American Journal of Psychiatry, 2007; 164: 1206-1213.
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 (such as Zoloft) 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.
United States, January 22, 2007: Archives of Internal Medicine published a study that reviewed the relationship between regular use of newer antidepressants, like Zoloft, and fractures. The study examined a group of Canadians that were aged 50 or older and concluded that daily newer antidepressant use in adults 50 years and older was associated with a 2-fold increased risk of bone fractures because of falls. Source: J. Brent Richards, “Effect of Selective Serotonin Reuptake Inhibitors on the Risk of Fracture,” Archives of Internal Medicine, Vol. 167, January 22, 2007.
Denmark, November 01, 2006: An Epidemiology study found that pregnant women who took newer antidepressants (such as Zoloft) 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.
United Kingdom, November 01, 2006: The British Journal of Psychiatry published a study that found five percent of children taking antidepressants (like Zoloft) were involved in self-harm or suicidal events, compared with three percent of those taking dummy pills. Source: Bernadka Dubicka MD, Sarah Hadley MSc and Christopher Roberts PhD, “Suicidal behaviour in youths with depression treated with new-generation antidepressants – Meta-analysis,” British Journal Of Psychiatry, Vol. 189, November 2006.
United States, October 01, 2006: A study presented at the American Society for Reproductive Medicine conference on two men who, while on antidepressants (one of them being Zoloft), had their sperm counts drop dramatically to almost zero. However, recovered to healthy levels when the drugs were suspended. Source: Cigdem Tanrikut and Peter N. Schlegel, “Antidepressant-Associated Changes in Semen Parameters,” Urology, Vol. 69, No. 1.
United States, August 01, 2006: The Archives of General Psychiatry published a study which found that children taking newer antidepressants like Zoloft, were 1.52 times more likely to attempt suicide and 15 times more likely to succeed in the attempt than those not taking the drugs. Source: Mark Olfson, MD, MPH, et al., “Antidepressant Drug Therapy and Suicide in Severely Depressed Children and Adults,” The Archives of General Psychiatry, Vol. 63, August 2006.
United Kingdom, February 19, 2005: The British Medical Journal published a study that found an increased risk of non-fatal self-harm in people taking newer antidepressants (including Zoloft) compared to those taking a placebo. Source: Dean Fergusson, David Healy, et al., “Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials,” British Medical Journal, Vol. 330, February 19, 2005.
United Kingdom, February 05, 2005: The Lancet published a study that found that infants whose mothers took antidepressants while pregnant could suffer withdrawal effects. The study conducted by researchers at the University of British Columbia, concluded, “risks of neonatal [newborn] convulsions and neonatal withdrawal syndrome seem to be increased with all SSRIs [newer antidepressants, such a Zoloft].” Furthermore, most of these cases were involving the use of Paroxetine (Paxil). Source: Emilio J. Sanz, et al., “Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis,” The Lancet, Vol. 365, February 5, 2005.
United States, November 22, 2004: Archives of Internal Medicine published a study on the risk of abnormal bleeding associated with antidepressants (such as Zoloft). The researchers concluded, “In a large population of new antidepressant users we found a significant association between degree of serotonin reuptake inhibition by antidepressants and risk of hospital admission for abnormal bleeding as the primary diagnosis. An increased risk of abnormal bleeding was strongly associated with the degree of serotonin reuptake inhibition.” Source: Welmoed E. E. Meijer, PhD., et al., “Association of Risk of Abnormal Bleeding With Degree of Serotonin Reuptake Inhibition by Antidepressants,” Archives of Internal Medicine, Vol. 164, November 22, 2004.
United States, August 20, 2004: A Columbia University review of the pediatric clinical trials of Sertraline (Zoloft), Citalopram, Venlafaxine, Bupropion, Paroxetine, Fluoxetine, Fluvoxamine, Nefazodone and Mirtazapine found that young people who took them could experience suicidal thoughts or actions. Dr. Tarek Hammand of the FDA’s Division of Neuropharmacological Drug Products performed an analysis based on the Columbia University review, and stated that his analysis also “…indicates a statistically significant association of suicidal events with antidepressant drug treatment in short-term pediatric clinical trials for all indications.” Source: “Follow-up Consult of August 16, 2004 by Andrew Mosholder on Suicidality in pediatric clinical trials with Paroxetine and other antidepressant drugs,” letter from the Office of Drug Safety, August 16, 2004.
United States, January 26, 2004: Drug Safety Research issued a special report on newer antidepressants (including Zoloft) that concluded, “The higher than expected numbers of suicidal and aggressive behaviors observed in some clinical trials of antidepressants in children also can be seen in spontaneous adverse event … . The data show that suicidal/aggressive behaviors are reported in both adults and children, but more than twice as often in children. Finally, while two drugs now carry warnings about this risk, similar risks were reported for the four drugs without warnings.” Source: Thomas J. Moore, “Antidepressant Drugs and Suicidal/Aggressive Behaviors,” Drug Safety Research – Special Report, Washington, D.C., January 26, 2004.
Finland, July 15, 2003: A Finnish study published in the Archives of General Psychiatry found that infants whose mothers took newer antidepressants, such as Zoloft, 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, January 01, 2003: The Archives of Internal Medicine published a study that examined the risk of upper gastrointestinal tract (GI) bleeding with use of antidepressants, such as Zoloft. They concluded that there is an increased risk of upper GI bleeding when using any newer antidepressants. Moreover, when aspirin was combined with newer antidepressants, it increased the risk further. Source: Susanne Oksbjerg Dalton, MD, et al., “Use of Selective Serotonin Reuptake Inhibitors and Risk of Upper Gastrointestinal Tract Bleeding,” Archives of Internal Medicine, Vol. 163, January 13, 2003.
United States, January 01, 2001: The Journal of Clinical Psychiatry published a study that assessed the impact of behavior adverse reactions associated with the use of antidepressants (such as Zoloft), such as psychosis and mania, leading to psychiatric hospital incarceration. The authors found that a significant proportion of psychiatric hospitalizations they reviewed were due to antidepressant associated psychotic or manic symptoms. Source: Adrian Preda, MD., et al., “Antidepressant-Associated Mania and Psychosis Resulting in Psychiatric Admissions,” Journal of Clinical Psychiatry, Vol. 62, No. 1, January 2001.
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