There have been 42 studies in nine countries (Netherlands, Iceland, Norway, United States, Finland, Canada, Denmark, United Kingdom and Sweden) on Paxil. These studies are as follows:
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 Paxil) 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 the Nordic Countries: Denmark, Finland, Iceland, Sweden and Norway. The authors found that mothers who used SSRIs (newer antidepressants, such as Paxil) 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 19, 2011: A study was published in the Journal of Clinical Oncology that looked at the obesity rates of 9,284 adults who had a diagnosis of cancer between the ages of 5 to 9. They found that one of the factors contributing to their obesity rates were certain antidepressant drugs taken, including Paxil. Source: Daniel M. Green, et al., “Risk Factors for Obesity in Adult Survivors of Childhood Cancer: A Report From the Childhood Cancer Survivor Study,” Journal of Clinical Oncology, December 19, 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, February 22, 2011: The Journal of Clinical Psychiatry published a study where researchers found that, across all disorders, overall suicidality incidence was similar between Paroxetine (Paxil) and placebo. In addition, a higher frequency of suicidal behavior occurred with Paroxetine (Paxil) in treatment of major depressive disorder. Source: David J. Carpenter, MSc, PharmD, et al., “Meta-Analysis of Efficacy and Treatment-Emergent Suicidality in Adults by Psychiatric Indication and Age Subgroup Following Initiation of Paroxetine Therapy: A Complete Set of Randomized Placebo-Controlled Trials,” Journal of Clinical Psychiatry, February 22, 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 Paxil), 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.
Canada, July 13, 2010: The authors of a study in the Canadian Medical Association Journal reviewed the risk of spontaneous abortion in relation to antidepressant use during pregnancy. Based on the Quebec Pregnancy Registry, they found 284 women who had an abortion and at least one prescription for an antidepressant during her pregnancy. Based on their review, they found, “The use of antidepressants, especially Paroxetine [Paxil], venlafaxine or the combined use of different classes of antidepressants, during pregnancy was associated with an increased risk of spontaneous abortion.” Source: Hamid Reza Nakhai-Pour MD PhD, Perrine Broy BSc, Anick Berard PhD, “Use of antidepressants during pregnancy and the risk of spontaneous abortion,” Canadian Medical Association Journal, Vol. 182, No. 10, July 12, 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 Paxil) 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 Paxil), 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 Paxil] 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 Paxil) 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, February 08, 2010: The British Medical Journal published a study on the mortality rates of women using SSRIs while receiving Tamoxifen treatment for breast cancer. The authors concluded that Paroxetine (Paxil) use during Tamoxifen treatment is associated with an increased risk of death from breast cancer. Source: Catherine M. Kelly, et al., “Selective serotonin reuptake inhibitors and breast cancer mortality in women receiving tamoxifen: a population based cohort study” British Medical Journal, February 8, 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], January 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.
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 an 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.
United States, June 10, 2009: The journal Fertility & Sterility published a study that assessed the effects of a selective serotonin reuptake inhibitor on semen amounts. In men with normal semen parameters (overall quantity), Paroxetine (Paxil) induced abnormal sperm DNA fragmentation in a significant proportion of subjects, without a measurable effect on the overall quantity of semen. The fertility potential of a substantial number of men on Paroxetine may be adversely affected by these changes in sperm DNA integrity. Source: Cigdem Tanrikut, M.D., et al., “Adverse effect of Paroxetine on sperm,” Fertility & Sterility, June 10, 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 Paxil). 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 Paxil] 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 Paxil, 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 Paxil), 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 Paxil) 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 Paxil, 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.
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.
Denmark, November 01, 2006: An Epidemiology study found that pregnant women who took newer antidepressants (such as Paxil) 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 States, November 01, 2006: The Journal of Clinical Psychiatry reported that about seven of every ten people who take antidepressants, such as Paxil, have impaired driving ability due to the drugs. The study showed that driving on these drugs make the roads more dangerous, slowing down reaction times and leaving users drowsy. About 190 million antidepressant prescriptions were written in the U.S. in 2005 and about 16% of people who take the drugs had severe motor impairments after taking them. Source: Alexander Brunnauer, Ph.D., et al., “Antidepressants and Driving Ability: Results from a Clinical Study,” Journal of Clinical Psychiatry, Vol. 67, No. 11, November 2006.
United Kingdom, November 01, 2006: The British Journal of Psychiatry published a study that found five percent of children taking antidepressants (such as Paxil) 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 Kingdom, September 01, 2006: A study published in Public Library of Science Medicine determined that newer antidepressants could increase the risk of violence in people taking them. They looked specifically at GlaxoSmithKline’s Paxil and concluded the drug raises the risk of severe violence in some people. Source: Healy M.D., David, Herxheimer, Andrew, Menkes, David B., “Antidepressants and Violence: Problems at the Interface of Medicine and Law,” Public Library of Science Medicine, September 2006.
United States, August 01, 2006: The Archives of General Psychiatry published a study which found that children taking newer antidepressants like Paxil, 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 Paxil) 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, August 22, 2005: The journal BMC Medicine published a study that reported, “The data strongly suggests that the use of SSRIs [newer antidepressants] is connected with an increased intensity and suicide attempts per year.” It also found that Paxil was 7 times more likely to induce suicide in people taking it than those taking placebo. Source: Ivar Aursnews, et al., “Suicide attempts in clinical trials with Paroxetine randomized against placebo,” BMC Medicine, August 22, 2005.
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 Paxil) 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].” 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 Paxil). 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 (Paxil), 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, 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 Paxil) 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 Paxil) 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 Paxil, 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, 2003: GlaxoSmithKline submitted a report to the FDA that showed that children given Paxil (Paroxetine) were more likely to become suicidal than those given placebos. It also showed that the drug did not improve their depression any better then placebo. Source: Gardiner Harris, “Antidepressant Study Seen to Back Expert,” The New York Times, August 20, 2004.
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 Paxil. 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 Paxil), 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, October 01, 2000: The American Journal of Epidemiology published two studies which demonstrated that Paxil presented a 720% increase in risk of breast cancer in females. Source: M. Gotterchio et al., “Antidepressant medication use on breast cancer,” American Journal of Epidemiology, Oct. 1, 2000, Vol. 152, p 951-957.
United Kingdom, December 01, 1995: In the British journal The Lancet, Dr. Miki Bloch of the National Institute of Mental Health and colleagues gave a report on patients who became suicidal and homicidal after stopping Paxil, including one man who was distraught over thoughts of harming “his own children.” Source: M. Bloch, S. V. Stager, A.R. Braun and D. R. Rainbow, “Severe Psychiatric Symptoms Associated with Paroxetine Withdrawal,” The Lancet, Vol. 346, December 1995.
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