Zoloft Information - Health Infographic

A Blockbuster Drug With a Black Box Warning TIMELINE Zoloft (also known as Lustral in the UK) is the brand name for the drug sertraline, a selective serotonin reuptake inhibitor (SSRI) antidepressant. SSRIS prevent receptors in the human brain from re-absorbing serotonin that has already been released. Serotonin helps maintain feelings of well-being in people, so preventing its re-absorption alleviates negative feelings. 1990 Source: http://www.fda.gov Sertraline becomes available in the United Kingdom. 25 ZOLOF Zoloft is used to treat... 1991 Zoloft introduced to United States market by Major Depressive Disorder (MDD) • Obsessive-Compulsive Disorder (OCD) • Panic Disorder 50 MG 25 M ZOLOFT Pfizer. ZOLOFT • Posttraumatic Stress Disorder (PTSD) 1992 Premenstrual Dysphoric Disorder (PMDD) After comedian Social Anxiety Disorder (SAD) Phil Hartman is killed by his wife, who then took her own life and who was taking Zoloft at the time, Hartman's estate files the suit against Pfizer claiming that Zoloft caused the violent behavior and that the company failed to disclose the drug's side effects. 1994 COMMON ADVERSE SIDE EFFECTS: Sertraline enters Australian Pooled analyses of short-term placebo-controlled trials of antidepressant drugs market. (SSRIS and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) 1996 with major depressive disorder (MDD) and other psychiatric disorders. Sertraline becomes Source: http://www.pfizer.com most often prescribed antidepressant in Australia. FDA O ZOLOFT Vs O PLACEBO Vs O U.S. FDA sues Pfizer for marketing Zoloft for off-label uses. Pfizer Reported Disorders Autonomic Nervous System 14% Coccococccocco Ejaculation Failure 1% Dry Mouth Increased Sweating Central & Peripheral Nerv. System 14% 1999 7% Ccccoco 2% Zoloft comes under public scrutiny after authorities reveal that one of the two shooters involved in the Columbine High School massacre had been taking the drug. 13% Somnolence Coccccocccoco 12% Dizziness Coccocoocc0 25%000 Headache 23% 2% Paresthesia 1% 7% cccccco Tremor 00 2% Skin & Appendages 3% 000 Rash 00 2% 2002 Gastrointestinal 6% Anorexia 00 2% FDA approves 6% 000000 Constipation 4% sertraline for use in ccccccocccocccoccccco treating children aged 6 or older with severe obsessive-compulsive disorder (OCD). Previously, sertraline approved in U.S. for use by adults aged 18 and over. 20% Diarrhea/Loose Stools 10% 6+ Dyspepsia Nausea 8% 0000 4% Ccccoc00 Years 25%0000 11% 4% Vomiting General 12% 7% Fatigue Psychiatric Disorders 5% Agitation Anxiety Insomnia Decreased Libido 3% 4% 0000 3% 2003 21% 11% 6% 00 UK Medicines and 5% Nervousness 4% MHRA Healthcare products Regulatory Agency issues guidance that most SSRIS are not suitable for the treatment of depression YEARS in patients under 18. Sertraline, however, may still be used in the UK for the treatment of OCD in children and Cocco Special Senses 3% 000 Abnormal Vision 00 [2% UNDER 18 Source: http://www.fda.gov WARNING ADVERSE EFFECTS NOT PUBLICIZED BY PFIZER Some adverse side effects are so severe-and were not sufficiently publicized by the adolescents. manufacturer-that some sufferers are bringing lawsuits for compensation. 2004 These include: Class action violent/hostile behavior commenced against Pfizer, alleging that the drugmaker misled physicians and the public about Zoloft's safety and efficacy, especially in regard to the antidepressant's suicide risks and withdrawal symptoms. birth defects ZOLOFT suicidality 2005 FDA adds a black dependency box warning concerning pediatric suicidal behavior to all FDA antidepressants, including sertraline. Black Box WARNING BIRTH DEFECTS While all SSRIS have been linked to birth defects, Zoloft in particular has been identified as a 2006 ZOLOFT PATENT potential cause of numerous birth defects in children born to mothers who were taking the U.S. patent for Zoloft expires, allowing sertraline to become drug while pregnant. These include EXPIRED available in generic form. O clubbed foot 2007 O cleft lip/palate 29,652,000 Prescriptions FDA again changes labeling to add a warning regarding suicidal behavior in Q delayed development persistent pulmonary hypertension (PPHN) Place young adults ages 18 to 24. gastroschisis Zoloft is the most prescribed antidepressant on the U.S. retail market, with 29,652,000 heart defects O skull defects O brain/spinal cord defects prescrip O premature birth 2009 to date suggests causal connection Research O miscarriage between SSRIS, including sertraline, and birth defects in children born to mothers taking the drugs while pregnant. O withdrawal symptoms ZOLOFT A Blockbuster Drug With a Black Box Warning TIMELINE Zoloft (also known as Lustral in the UK) is the brand name for the drug sertraline, a selective serotonin reuptake inhibitor (SSRI) antidepressant. SSRIS prevent receptors in the human brain from re-absorbing serotonin that has already been released. Serotonin helps maintain feelings of well-being in people, so preventing its re-absorption alleviates negative feelings. 1990 Source: http://www.fda.gov Sertraline becomes available in the United Kingdom. 25 ZOLOF Zoloft is used to treat... 1991 Zoloft introduced to United States market by Major Depressive Disorder (MDD) • Obsessive-Compulsive Disorder (OCD) • Panic Disorder 50 MG 25 M ZOLOFT Pfizer. ZOLOFT • Posttraumatic Stress Disorder (PTSD) 1992 Premenstrual Dysphoric Disorder (PMDD) After comedian Social Anxiety Disorder (SAD) Phil Hartman is killed by his wife, who then took her own life and who was taking Zoloft at the time, Hartman's estate files the suit against Pfizer claiming that Zoloft caused the violent behavior and that the company failed to disclose the drug's side effects. 1994 COMMON ADVERSE SIDE EFFECTS: Sertraline enters Australian Pooled analyses of short-term placebo-controlled trials of antidepressant drugs market. (SSRIS and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) 1996 with major depressive disorder (MDD) and other psychiatric disorders. Sertraline becomes Source: http://www.pfizer.com most often prescribed antidepressant in Australia. FDA O ZOLOFT Vs O PLACEBO Vs O U.S. FDA sues Pfizer for marketing Zoloft for off-label uses. Pfizer Reported Disorders Autonomic Nervous System 14% Coccococccocco Ejaculation Failure 1% Dry Mouth Increased Sweating Central & Peripheral Nerv. System 14% 1999 7% Ccccoco 2% Zoloft comes under public scrutiny after authorities reveal that one of the two shooters involved in the Columbine High School massacre had been taking the drug. 13% Somnolence Coccccocccoco 12% Dizziness Coccocoocc0 25%000 Headache 23% 2% Paresthesia 1% 7% cccccco Tremor 00 2% Skin & Appendages 3% 000 Rash 00 2% 2002 Gastrointestinal 6% Anorexia 00 2% FDA approves 6% 000000 Constipation 4% sertraline for use in ccccccocccocccoccccco treating children aged 6 or older with severe obsessive-compulsive disorder (OCD). Previously, sertraline approved in U.S. for use by adults aged 18 and over. 20% Diarrhea/Loose Stools 10% 6+ Dyspepsia Nausea 8% 0000 4% Ccccoc00 Years 25%0000 11% 4% Vomiting General 12% 7% Fatigue Psychiatric Disorders 5% Agitation Anxiety Insomnia Decreased Libido 3% 4% 0000 3% 2003 21% 11% 6% 00 UK Medicines and 5% Nervousness 4% MHRA Healthcare products Regulatory Agency issues guidance that most SSRIS are not suitable for the treatment of depression YEARS in patients under 18. Sertraline, however, may still be used in the UK for the treatment of OCD in children and Cocco Special Senses 3% 000 Abnormal Vision 00 [2% UNDER 18 Source: http://www.fda.gov WARNING ADVERSE EFFECTS NOT PUBLICIZED BY PFIZER Some adverse side effects are so severe-and were not sufficiently publicized by the adolescents. manufacturer-that some sufferers are bringing lawsuits for compensation. 2004 These include: Class action violent/hostile behavior commenced against Pfizer, alleging that the drugmaker misled physicians and the public about Zoloft's safety and efficacy, especially in regard to the antidepressant's suicide risks and withdrawal symptoms. birth defects ZOLOFT suicidality 2005 FDA adds a black dependency box warning concerning pediatric suicidal behavior to all FDA antidepressants, including sertraline. Black Box WARNING BIRTH DEFECTS While all SSRIS have been linked to birth defects, Zoloft in particular has been identified as a 2006 ZOLOFT PATENT potential cause of numerous birth defects in children born to mothers who were taking the U.S. patent for Zoloft expires, allowing sertraline to become drug while pregnant. These include EXPIRED available in generic form. O clubbed foot 2007 O cleft lip/palate 29,652,000 Prescriptions FDA again changes labeling to add a warning regarding suicidal behavior in Q delayed development persistent pulmonary hypertension (PPHN) Place young adults ages 18 to 24. gastroschisis Zoloft is the most prescribed antidepressant on the U.S. retail market, with 29,652,000 heart defects O skull defects O brain/spinal cord defects prescrip O premature birth 2009 to date suggests causal connection Research O miscarriage between SSRIS, including sertraline, and birth defects in children born to mothers taking the drugs while pregnant. O withdrawal symptoms ZOLOFT A Blockbuster Drug With a Black Box Warning TIMELINE Zoloft (also known as Lustral in the UK) is the brand name for the drug sertraline, a selective serotonin reuptake inhibitor (SSRI) antidepressant. SSRIS prevent receptors in the human brain from re-absorbing serotonin that has already been released. Serotonin helps maintain feelings of well-being in people, so preventing its re-absorption alleviates negative feelings. 1990 Source: http://www.fda.gov Sertraline becomes available in the United Kingdom. 25 ZOLOF Zoloft is used to treat... 1991 Zoloft introduced to United States market by Major Depressive Disorder (MDD) • Obsessive-Compulsive Disorder (OCD) • Panic Disorder 50 MG 25 M ZOLOFT Pfizer. ZOLOFT • Posttraumatic Stress Disorder (PTSD) 1992 Premenstrual Dysphoric Disorder (PMDD) After comedian Social Anxiety Disorder (SAD) Phil Hartman is killed by his wife, who then took her own life and who was taking Zoloft at the time, Hartman's estate files the suit against Pfizer claiming that Zoloft caused the violent behavior and that the company failed to disclose the drug's side effects. 1994 COMMON ADVERSE SIDE EFFECTS: Sertraline enters Australian Pooled analyses of short-term placebo-controlled trials of antidepressant drugs market. (SSRIS and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) 1996 with major depressive disorder (MDD) and other psychiatric disorders. Sertraline becomes Source: http://www.pfizer.com most often prescribed antidepressant in Australia. FDA O ZOLOFT Vs O PLACEBO Vs O U.S. FDA sues Pfizer for marketing Zoloft for off-label uses. Pfizer Reported Disorders Autonomic Nervous System 14% Coccococccocco Ejaculation Failure 1% Dry Mouth Increased Sweating Central & Peripheral Nerv. System 14% 1999 7% Ccccoco 2% Zoloft comes under public scrutiny after authorities reveal that one of the two shooters involved in the Columbine High School massacre had been taking the drug. 13% Somnolence Coccccocccoco 12% Dizziness Coccocoocc0 25%000 Headache 23% 2% Paresthesia 1% 7% cccccco Tremor 00 2% Skin & Appendages 3% 000 Rash 00 2% 2002 Gastrointestinal 6% Anorexia 00 2% FDA approves 6% 000000 Constipation 4% sertraline for use in ccccccocccocccoccccco treating children aged 6 or older with severe obsessive-compulsive disorder (OCD). Previously, sertraline approved in U.S. for use by adults aged 18 and over. 20% Diarrhea/Loose Stools 10% 6+ Dyspepsia Nausea 8% 0000 4% Ccccoc00 Years 25%0000 11% 4% Vomiting General 12% 7% Fatigue Psychiatric Disorders 5% Agitation Anxiety Insomnia Decreased Libido 3% 4% 0000 3% 2003 21% 11% 6% 00 UK Medicines and 5% Nervousness 4% MHRA Healthcare products Regulatory Agency issues guidance that most SSRIS are not suitable for the treatment of depression YEARS in patients under 18. Sertraline, however, may still be used in the UK for the treatment of OCD in children and Cocco Special Senses 3% 000 Abnormal Vision 00 [2% UNDER 18 Source: http://www.fda.gov WARNING ADVERSE EFFECTS NOT PUBLICIZED BY PFIZER Some adverse side effects are so severe-and were not sufficiently publicized by the adolescents. manufacturer-that some sufferers are bringing lawsuits for compensation. 2004 These include: Class action violent/hostile behavior commenced against Pfizer, alleging that the drugmaker misled physicians and the public about Zoloft's safety and efficacy, especially in regard to the antidepressant's suicide risks and withdrawal symptoms. birth defects ZOLOFT suicidality 2005 FDA adds a black dependency box warning concerning pediatric suicidal behavior to all FDA antidepressants, including sertraline. Black Box WARNING BIRTH DEFECTS While all SSRIS have been linked to birth defects, Zoloft in particular has been identified as a 2006 ZOLOFT PATENT potential cause of numerous birth defects in children born to mothers who were taking the U.S. patent for Zoloft expires, allowing sertraline to become drug while pregnant. These include EXPIRED available in generic form. O clubbed foot 2007 O cleft lip/palate 29,652,000 Prescriptions FDA again changes labeling to add a warning regarding suicidal behavior in Q delayed development persistent pulmonary hypertension (PPHN) Place young adults ages 18 to 24. gastroschisis Zoloft is the most prescribed antidepressant on the U.S. retail market, with 29,652,000 heart defects O skull defects O brain/spinal cord defects prescrip O premature birth 2009 to date suggests causal connection Research O miscarriage between SSRIS, including sertraline, and birth defects in children born to mothers taking the drugs while pregnant. O withdrawal symptoms ZOLOFT A Blockbuster Drug With a Black Box Warning TIMELINE Zoloft (also known as Lustral in the UK) is the brand name for the drug sertraline, a selective serotonin reuptake inhibitor (SSRI) antidepressant. SSRIS prevent receptors in the human brain from re-absorbing serotonin that has already been released. Serotonin helps maintain feelings of well-being in people, so preventing its re-absorption alleviates negative feelings. 1990 Source: http://www.fda.gov Sertraline becomes available in the United Kingdom. 25 ZOLOF Zoloft is used to treat... 1991 Zoloft introduced to United States market by Major Depressive Disorder (MDD) • Obsessive-Compulsive Disorder (OCD) • Panic Disorder 50 MG 25 M ZOLOFT Pfizer. ZOLOFT • Posttraumatic Stress Disorder (PTSD) 1992 Premenstrual Dysphoric Disorder (PMDD) After comedian Social Anxiety Disorder (SAD) Phil Hartman is killed by his wife, who then took her own life and who was taking Zoloft at the time, Hartman's estate files the suit against Pfizer claiming that Zoloft caused the violent behavior and that the company failed to disclose the drug's side effects. 1994 COMMON ADVERSE SIDE EFFECTS: Sertraline enters Australian Pooled analyses of short-term placebo-controlled trials of antidepressant drugs market. (SSRIS and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) 1996 with major depressive disorder (MDD) and other psychiatric disorders. Sertraline becomes Source: http://www.pfizer.com most often prescribed antidepressant in Australia. FDA O ZOLOFT Vs O PLACEBO Vs O U.S. FDA sues Pfizer for marketing Zoloft for off-label uses. Pfizer Reported Disorders Autonomic Nervous System 14% Coccococccocco Ejaculation Failure 1% Dry Mouth Increased Sweating Central & Peripheral Nerv. System 14% 1999 7% Ccccoco 2% Zoloft comes under public scrutiny after authorities reveal that one of the two shooters involved in the Columbine High School massacre had been taking the drug. 13% Somnolence Coccccocccoco 12% Dizziness Coccocoocc0 25%000 Headache 23% 2% Paresthesia 1% 7% cccccco Tremor 00 2% Skin & Appendages 3% 000 Rash 00 2% 2002 Gastrointestinal 6% Anorexia 00 2% FDA approves 6% 000000 Constipation 4% sertraline for use in ccccccocccocccoccccco treating children aged 6 or older with severe obsessive-compulsive disorder (OCD). Previously, sertraline approved in U.S. for use by adults aged 18 and over. 20% Diarrhea/Loose Stools 10% 6+ Dyspepsia Nausea 8% 0000 4% Ccccoc00 Years 25%0000 11% 4% Vomiting General 12% 7% Fatigue Psychiatric Disorders 5% Agitation Anxiety Insomnia Decreased Libido 3% 4% 0000 3% 2003 21% 11% 6% 00 UK Medicines and 5% Nervousness 4% MHRA Healthcare products Regulatory Agency issues guidance that most SSRIS are not suitable for the treatment of depression YEARS in patients under 18. Sertraline, however, may still be used in the UK for the treatment of OCD in children and Cocco Special Senses 3% 000 Abnormal Vision 00 [2% UNDER 18 Source: http://www.fda.gov WARNING ADVERSE EFFECTS NOT PUBLICIZED BY PFIZER Some adverse side effects are so severe-and were not sufficiently publicized by the adolescents. manufacturer-that some sufferers are bringing lawsuits for compensation. 2004 These include: Class action violent/hostile behavior commenced against Pfizer, alleging that the drugmaker misled physicians and the public about Zoloft's safety and efficacy, especially in regard to the antidepressant's suicide risks and withdrawal symptoms. birth defects ZOLOFT suicidality 2005 FDA adds a black dependency box warning concerning pediatric suicidal behavior to all FDA antidepressants, including sertraline. Black Box WARNING BIRTH DEFECTS While all SSRIS have been linked to birth defects, Zoloft in particular has been identified as a 2006 ZOLOFT PATENT potential cause of numerous birth defects in children born to mothers who were taking the U.S. patent for Zoloft expires, allowing sertraline to become drug while pregnant. These include EXPIRED available in generic form. O clubbed foot 2007 O cleft lip/palate 29,652,000 Prescriptions FDA again changes labeling to add a warning regarding suicidal behavior in Q delayed development persistent pulmonary hypertension (PPHN) Place young adults ages 18 to 24. gastroschisis Zoloft is the most prescribed antidepressant on the U.S. retail market, with 29,652,000 heart defects O skull defects O brain/spinal cord defects prescrip O premature birth 2009 to date suggests causal connection Research O miscarriage between SSRIS, including sertraline, and birth defects in children born to mothers taking the drugs while pregnant. O withdrawal symptoms ZOLOFT A Blockbuster Drug With a Black Box Warning TIMELINE Zoloft (also known as Lustral in the UK) is the brand name for the drug sertraline, a selective serotonin reuptake inhibitor (SSRI) antidepressant. SSRIS prevent receptors in the human brain from re-absorbing serotonin that has already been released. Serotonin helps maintain feelings of well-being in people, so preventing its re-absorption alleviates negative feelings. 1990 Source: http://www.fda.gov Sertraline becomes available in the United Kingdom. 25 ZOLOF Zoloft is used to treat... 1991 Zoloft introduced to United States market by Major Depressive Disorder (MDD) • Obsessive-Compulsive Disorder (OCD) • Panic Disorder 50 MG 25 M ZOLOFT Pfizer. ZOLOFT • Posttraumatic Stress Disorder (PTSD) 1992 Premenstrual Dysphoric Disorder (PMDD) After comedian Social Anxiety Disorder (SAD) Phil Hartman is killed by his wife, who then took her own life and who was taking Zoloft at the time, Hartman's estate files the suit against Pfizer claiming that Zoloft caused the violent behavior and that the company failed to disclose the drug's side effects. 1994 COMMON ADVERSE SIDE EFFECTS: Sertraline enters Australian Pooled analyses of short-term placebo-controlled trials of antidepressant drugs market. (SSRIS and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) 1996 with major depressive disorder (MDD) and other psychiatric disorders. Sertraline becomes Source: http://www.pfizer.com most often prescribed antidepressant in Australia. FDA O ZOLOFT Vs O PLACEBO Vs O U.S. FDA sues Pfizer for marketing Zoloft for off-label uses. Pfizer Reported Disorders Autonomic Nervous System 14% Coccococccocco Ejaculation Failure 1% Dry Mouth Increased Sweating Central & Peripheral Nerv. System 14% 1999 7% Ccccoco 2% Zoloft comes under public scrutiny after authorities reveal that one of the two shooters involved in the Columbine High School massacre had been taking the drug. 13% Somnolence Coccccocccoco 12% Dizziness Coccocoocc0 25%000 Headache 23% 2% Paresthesia 1% 7% cccccco Tremor 00 2% Skin & Appendages 3% 000 Rash 00 2% 2002 Gastrointestinal 6% Anorexia 00 2% FDA approves 6% 000000 Constipation 4% sertraline for use in ccccccocccocccoccccco treating children aged 6 or older with severe obsessive-compulsive disorder (OCD). Previously, sertraline approved in U.S. for use by adults aged 18 and over. 20% Diarrhea/Loose Stools 10% 6+ Dyspepsia Nausea 8% 0000 4% Ccccoc00 Years 25%0000 11% 4% Vomiting General 12% 7% Fatigue Psychiatric Disorders 5% Agitation Anxiety Insomnia Decreased Libido 3% 4% 0000 3% 2003 21% 11% 6% 00 UK Medicines and 5% Nervousness 4% MHRA Healthcare products Regulatory Agency issues guidance that most SSRIS are not suitable for the treatment of depression YEARS in patients under 18. Sertraline, however, may still be used in the UK for the treatment of OCD in children and Cocco Special Senses 3% 000 Abnormal Vision 00 [2% UNDER 18 Source: http://www.fda.gov WARNING ADVERSE EFFECTS NOT PUBLICIZED BY PFIZER Some adverse side effects are so severe-and were not sufficiently publicized by the adolescents. manufacturer-that some sufferers are bringing lawsuits for compensation. 2004 These include: Class action violent/hostile behavior commenced against Pfizer, alleging that the drugmaker misled physicians and the public about Zoloft's safety and efficacy, especially in regard to the antidepressant's suicide risks and withdrawal symptoms. birth defects ZOLOFT suicidality 2005 FDA adds a black dependency box warning concerning pediatric suicidal behavior to all FDA antidepressants, including sertraline. Black Box WARNING BIRTH DEFECTS While all SSRIS have been linked to birth defects, Zoloft in particular has been identified as a 2006 ZOLOFT PATENT potential cause of numerous birth defects in children born to mothers who were taking the U.S. patent for Zoloft expires, allowing sertraline to become drug while pregnant. These include EXPIRED available in generic form. O clubbed foot 2007 O cleft lip/palate 29,652,000 Prescriptions FDA again changes labeling to add a warning regarding suicidal behavior in Q delayed development persistent pulmonary hypertension (PPHN) Place young adults ages 18 to 24. gastroschisis Zoloft is the most prescribed antidepressant on the U.S. retail market, with 29,652,000 heart defects O skull defects O brain/spinal cord defects prescrip O premature birth 2009 to date suggests causal connection Research O miscarriage between SSRIS, including sertraline, and birth defects in children born to mothers taking the drugs while pregnant. O withdrawal symptoms ZOLOFT A Blockbuster Drug With a Black Box Warning TIMELINE Zoloft (also known as Lustral in the UK) is the brand name for the drug sertraline, a selective serotonin reuptake inhibitor (SSRI) antidepressant. SSRIS prevent receptors in the human brain from re-absorbing serotonin that has already been released. Serotonin helps maintain feelings of well-being in people, so preventing its re-absorption alleviates negative feelings. 1990 Source: http://www.fda.gov Sertraline becomes available in the United Kingdom. 25 ZOLOF Zoloft is used to treat... 1991 Zoloft introduced to United States market by Major Depressive Disorder (MDD) • Obsessive-Compulsive Disorder (OCD) • Panic Disorder 50 MG 25 M ZOLOFT Pfizer. ZOLOFT • Posttraumatic Stress Disorder (PTSD) 1992 Premenstrual Dysphoric Disorder (PMDD) After comedian Social Anxiety Disorder (SAD) Phil Hartman is killed by his wife, who then took her own life and who was taking Zoloft at the time, Hartman's estate files the suit against Pfizer claiming that Zoloft caused the violent behavior and that the company failed to disclose the drug's side effects. 1994 COMMON ADVERSE SIDE EFFECTS: Sertraline enters Australian Pooled analyses of short-term placebo-controlled trials of antidepressant drugs market. (SSRIS and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) 1996 with major depressive disorder (MDD) and other psychiatric disorders. Sertraline becomes Source: http://www.pfizer.com most often prescribed antidepressant in Australia. FDA O ZOLOFT Vs O PLACEBO Vs O U.S. FDA sues Pfizer for marketing Zoloft for off-label uses. Pfizer Reported Disorders Autonomic Nervous System 14% Coccococccocco Ejaculation Failure 1% Dry Mouth Increased Sweating Central & Peripheral Nerv. System 14% 1999 7% Ccccoco 2% Zoloft comes under public scrutiny after authorities reveal that one of the two shooters involved in the Columbine High School massacre had been taking the drug. 13% Somnolence Coccccocccoco 12% Dizziness Coccocoocc0 25%000 Headache 23% 2% Paresthesia 1% 7% cccccco Tremor 00 2% Skin & Appendages 3% 000 Rash 00 2% 2002 Gastrointestinal 6% Anorexia 00 2% FDA approves 6% 000000 Constipation 4% sertraline for use in ccccccocccocccoccccco treating children aged 6 or older with severe obsessive-compulsive disorder (OCD). Previously, sertraline approved in U.S. for use by adults aged 18 and over. 20% Diarrhea/Loose Stools 10% 6+ Dyspepsia Nausea 8% 0000 4% Ccccoc00 Years 25%0000 11% 4% Vomiting General 12% 7% Fatigue Psychiatric Disorders 5% Agitation Anxiety Insomnia Decreased Libido 3% 4% 0000 3% 2003 21% 11% 6% 00 UK Medicines and 5% Nervousness 4% MHRA Healthcare products Regulatory Agency issues guidance that most SSRIS are not suitable for the treatment of depression YEARS in patients under 18. Sertraline, however, may still be used in the UK for the treatment of OCD in children and Cocco Special Senses 3% 000 Abnormal Vision 00 [2% UNDER 18 Source: http://www.fda.gov WARNING ADVERSE EFFECTS NOT PUBLICIZED BY PFIZER Some adverse side effects are so severe-and were not sufficiently publicized by the adolescents. manufacturer-that some sufferers are bringing lawsuits for compensation. 2004 These include: Class action violent/hostile behavior commenced against Pfizer, alleging that the drugmaker misled physicians and the public about Zoloft's safety and efficacy, especially in regard to the antidepressant's suicide risks and withdrawal symptoms. birth defects ZOLOFT suicidality 2005 FDA adds a black dependency box warning concerning pediatric suicidal behavior to all FDA antidepressants, including sertraline. Black Box WARNING BIRTH DEFECTS While all SSRIS have been linked to birth defects, Zoloft in particular has been identified as a 2006 ZOLOFT PATENT potential cause of numerous birth defects in children born to mothers who were taking the U.S. patent for Zoloft expires, allowing sertraline to become drug while pregnant. These include EXPIRED available in generic form. O clubbed foot 2007 O cleft lip/palate 29,652,000 Prescriptions FDA again changes labeling to add a warning regarding suicidal behavior in Q delayed development persistent pulmonary hypertension (PPHN) Place young adults ages 18 to 24. gastroschisis Zoloft is the most prescribed antidepressant on the U.S. retail market, with 29,652,000 heart defects O skull defects O brain/spinal cord defects prescrip O premature birth 2009 to date suggests causal connection Research O miscarriage between SSRIS, including sertraline, and birth defects in children born to mothers taking the drugs while pregnant. O withdrawal symptoms ZOLOFT