There have been 39 studies in nine countries (Canada, Iceland, Sweden, Norway, United Kingdom, Finland, United States, Denmark and Germany) on Prozac. 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 Prozac) 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.
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 Prozac) 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 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 Prozac) 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.
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.
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 Prozac), 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.
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 Prozac) 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 Prozac), 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 Prozac] 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 Prozac) 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 Prozac) 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 Prozac). 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.
Canada, June 30, 2008: BioPsychoSocial Medicine published a study that sought “to provide an overview of the literature examining the effects of pharmacologic and physical treatments for depression on Heart Rate Variability [HRV] in medically otherwise well patients with [Major Depressive Disorder].” After looking through the literature, the authors concluded, “The use of TCAs [older antidepressants] in depression leads to changes in HRV that are associated with increased risk of mortality.” Also, “… evidence shows that SSRIs [newer antidepressants, such as Prozac] are associated with small decreases in [heart rate] and an increase in one measure of HRV.” Source: Louis T van Zyl, et al., “Effects of antidepressant treatment on heart rate variability [HRV] in major depression: A quantitative review,” BioPsychoSocial Medicine, Vol. 2, No. 12, June 30 2008.
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 Prozac, 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 Prozac), 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 Prozac) 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 Prozac, 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 Prozac) 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 Prozac) 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, August 01, 2006: The Archives of General Psychiatry published a study which found that children taking newer antidepressants like Prozac, 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 States, March 01, 2006: The Journal of Child and Adolescent Psychopharmacology published a study on the frequency of common side effects from newer antidepressants (such as Prozac) in children, adolescents, and adults. The study found that restlessness, hyperkinesis [abnormal increase in muscle activity], hyperactivity, agitation and vomiting side effects were 2 to 3-fold more prevalent in children than in adolescents, and their rate was lowest in adults. The authors concluded that children are particularly vulnerable to specific side effects from newer antidepressants. Source: Daniel J. Safer, M.D. and Julie Magno Zito, Ph.D. “Treatment-Emergent Adverse Events from Selective Serotonin Reuptake Inhibitors by Age Group: Children versus Adolescents,” Journal of Child and Adolescent Psychopharmacology, Vol. 16, No. 1/2, 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 Prozac) 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 Prozac].” 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 Prozac). 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, Citalopram, Venlafaxine, Bupropion, Paroxetine, Fluoxetine (Prozac), 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, July 21, 2004: The Journal of the American Medical Association published a study that found there was a significantly higher risk of suicide and suicidal thoughts during the first 9 days of treatment with antidepressants (like Prozac) and that children who were first starting treatment were 4 times more likely to think about suicide, and 38 times more likely to commit suicide, and that children as young as 5 had committed suicide while taking these drugs. Source: Hershel Jick, MD, et al., “Antidepressants and the Risk of Suicidal Behaviors,” Journal of the American Medical Association, Vol. 292, No. 3, July 21, 2004.
United States, January 26, 2004: Drug Safety Research issued a special report on newer antidepressants (including Prozac) 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 Prozac, 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 Prozac. 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 (including Prozac), 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.
United States, July 01, 1997: In a Journal of Clinical Psychiatry study, Dr. John Zajecka reported that discontinuation [withdrawal] symptoms after treatment with Prozac can cause “aggressiveness and suicidal impulsivity.” Source: J. Zajecka, K. Tracy, and S. Mitchell, “Discontinuation Symptoms After Treatment with Selective Serotonin Reuptake Inhibitors: A Literature Review,” Journal of Clinical Psychiatry, Vol. 58, July 1997.
United States, January 28, 1995: In a study from the British Medical Journal entitled, “Antidepressants and Suicide” one of the authors stated, “The results indicate that only fluoxetine [Prozac] has a rate [of suicide] that seems to be substantially higher than that of other antidepressants.” Source: Susan S. Jick, Alan D. Dean and Hershel Jick, “Antidepressants and Suicide,” British Medical Journal, Vol. 310, Jan. 28, 1995.
United Kingdom, April 01, 1994: In a study published in CNS Drugs, the director of Cardiff’s University’s North Wales department of psychological medicine confirmed, “Some of the case reports regarding fluoxetine (Prozac) induced suicidal ideation do appear sufficiently well documented and detailed to sustain an argument that fluoxetine may lead to the emergence of suicidal ideation.” Source: David Healy, M.D. “The Fluoxetine and Suicide Controversy: A Review of the Evidence,” CNS Drugs, Vol. 1, No. 3, 1994.
United States, May 01, 1993: A study published in the Journal of the American Medical Association found that out of 117 mother who took Prozac during the first trimester had a 14.8% risk of miscarriage compared to 7.8% in mothers not exposed to fluoxetine (Prozac) or tricyclic 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 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.
United States, December 01, 1991: The Journal of Clinical Psychiatry published a study which stated, “Three depressed inpatients, 25-47 years of age, were re-exposed to fluoxetine [Prozac] after having previously made a serious suicide attempt while taking the drug. This is the first report, to our knowledge, of patients restarted on fluoxetine after a previous suicide attempt during fluoxetine treatment…. We observed that all three patients developed severe akathisia [severe restlessness] while taking fluoxetine, and they stated that the development of this syndrome, in the context of their depressive episode, is what precipitated their prior suicide attempts. When re-exposed to fluoxetine, the patients again developed akathisia and suicidal ideation. The suicidal feelings abated when the akathisia was treated by the discontinuation of the fluoxetine.…” Source: Anthony J. Rothschild, M.D., and Carol A. Locke, M.D., “Reexposure to Fluoxetine After Serious Suicide Attempts by Three Patients: The Role of Akathisia,” Journal of Clinical Psychiatry, December 1991.
United States, March 01, 1991: The Journal of the American Academy of Child and Adolescent Psychiatry published a study on three boys and three girls, age 10 to 17 years old, who “developed intense self-injurious ideation or behavior while receiving fluoxetine [Prozac] for treatment of obsessive-compulsive disorder…. Three patients made suicide gestures or attempts, one of which involved a massive overdose of fluoxetine. Three patients manifested persistent, driven self-injurious behavior and/or ideation that required restraints, seclusion, or one-on-one nursing care. Suicidal ideation or self-injurious behavior persisted up to one month after the fluoxetine was discontinued.” Source: Robert King, M.D., et al., “Emergency of Self-Destructive Phenomena in Children and Adolescents during Fluoxetine Treatment,” Journal of the American Academy of Child and Adolescent Psychiatry, March 1991.
United States, February 07, 1991: It was reported in The New England Journal of Medicine that there is a strong association in patients whom have suicidal ideation and are on fluoxetine [Prozac] treatment. The study reported on a 58-year-old man who “was started on fluoxetine (20 mg/day). Three days later he had violent suicidal thoughts and tried to hang himself with a rope. The fluoxetine was discontinued, with a complete disappearance of suicidal ideation four days later.” Source: Prakash Marsand, M.D., et al., “Suicidal Ideation Related to Fluoxetine Treatment,” The New England Journal of Medicine, February 7, 1991.
United States, February 01, 1990: Harvard doctors Martin Teicher and Jonathan Cole reported in the American Journal of Psychiatry that six of their patients had developed “intense, violent suicidal” thoughts soon after starting Prozac. One patient reported feeling like “jumping out of her skin.” So great was her “anxiety, fear, and turbulence that she felt ‘death would be a welcome result.'” Another patient “became violent, banging her head and mutilating herself….” Source: Martin Teicher, M.D. and Jonathan Cole, M.D., “Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment” American Journal of Psychiatry, Vol. 147, Is. 2, February 1990.
United States, March 01, 1986: An FDA safety reviewer of Prozac determined it “may exacerbate [worsen] certain depressive symptoms and signs.” Further, “Certain clinical risks of mild to moderate severity did appear to be associated with the use of [Prozac]…These potential risks include intensification of the vegetative [functioning involuntarily or unconsciously] signs and symptoms of depression.” Source: Richard Kapit, M .D., Safety Review of NDA 18-936 (Fluoxetine) of 23 March 1986.
Germany, May 01, 1984: The German Drug Regulatory Authority, BfArM, reported that during a study of Prozac (fluoxetine) there were 16 attempted suicides, of which two were successful. As patients with a suicide risk were excluded from the studies, “it is probable that this high proportion can be attributed to an action of the preparation [Prozac]….” Source: Kelly O’Meara, Psyched Out, How Psychiatry Sells Mental Illness and Pushes Pills that Kill, AuthorHouse, 2006, p. 115.
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