Zoloft

zoloft

Zoloft (sertraline) is an antidepressant medication is a member of the serotonin-specific reuptake inhibitor (SSRI) class, which works by increasing serotonin levels in the brain.  Though Zoloft was intended to be safer than older medications, it has been shown to increase the risk of suicide, birth defects and other serious side effects.

The FDA has issued multiple warnings about Zoloft and has required changes to its prescribing information and Pfizer, Zoloft’s manufacturer, has faced lawsuits for injuries caused by the medication.

Zoloft

Zoloft is the brand name of the generic medication, sertraline.  It is a member of the SSRI class of antidepressants and is approved for major depression, anxiety and panic disorders, post-traumatic stress disorder and premenstrual dysphoric disorder in adults and for obsessive-compulsive disorder in adolescents and adults.  It has also been used “off-label” for bipolar disorder, premature ejaculation, headaches and other conditions.

Neurotransmitters like norepinephrine, dopamine and serotonin are used as chemical messengers by the brain cells.  Antidepressants work by increasing neurotransmitter levels in the brain’s mood centers.  SSRI medications were invented to only affect serotonin which was thought to be make it more effective and safer, with fewer side effects.

Since Zoloft was introduced in 1994, it has been used in millions of people.  Though most people do not have severe side effects, it has shown to cause serious injury in some patients.  Beginning in 2004, the FDA has issued multiple warnings about the risks of Zoloft and Pfizer has faced multiple lawsuits for injuries caused by the medication and for improper marketing practices.

Zoloft and Suicide

Zoloft has been shown to increase the risk of suicide in those with depression, especially in those who are under 25, have a history of suicide or who are bipolar.  The FDA issued a “black box warning” in 2004, which required that information about the risk of suicide be printed at the top of prescribing information, enclosed in a black box.

Zoloft and Birth Defects

Zoloft was the second of the SSRI medications and was thought to be fairly safe during pregnancy because it does not affect norepinephrine.  It was used in millions of pregnant women but has been found to have an increased risk of miscarriage and birth defects.

An FDA warning about Zoloft birth defects was issued in 2006 and it has since been listed as a Pregnancy Category C medication.  These medications should not be taken by pregnant women unless absolutely necessary.

Birth defects linked to Zoloft use may include:

  • PPHN or Persistent Pulmonary Hypertension in Newborn, fatal in 10% of infants
  • HLHS, HRHS/Hypoplastic Left/Right Heart Syndrome, may be fatal in infants
  • Anencephaly (missing portion of brain, skull and scalp), fatal shortly after birth
  • Spina Bifida (missing part of vertebrae with spinal cord exposed), requires surgery and is 15% fatal by age 4
  • Cleft Palate or Lip (missing portion of upper front jaw or roof of mouth), may require surgery
  • Omphalocele (abdominal organs on outside of body), requires surgery and sometimes fatal
  • Scoliosis (curved spine), may require surgery
  • Club feet (feet curl inwards), may require surgery or extensive therapy
  • Autism Spectrum Disorder/ASD or Delayed Development Disorder/DDD
  • Withdrawal symptoms in infants

Zoloft and Serotonin Syndrome

Zoloft and other SSRIs may cause serotonin to build up in the brain which results in “serotonin syndrome”.  This is most common when Zoloft is taken with other serotonin medications including cough suppressants, migraine treatments and some herbal supplements.

Serotonin syndrome symptoms may include:

  • Unexpected high fever
  • Increased heart rate, abnormal heart beat
  • Loss of balance or coordination
  • Confusion or hallucinations
  • Seizures

Severe cases of serotonin syndrome may be life-threatening.  To reduce the risk, all medication use should be discussed with a doctor.

Zoloft withdrawal

Patients who take SSRIs for a long period of time may become physically dependent.  When Zoloft is suddenly discontinued, serotonin withdrawal symptoms can occur.  Some withdrawal symptoms may last for a long time.

Symptoms of SSRI discontinuation syndrome may include:

  • Dizziness
  • Nausea/Diarrhea
  • Headache
  • Chills or shivers
  • Brain “zaps”
  • Electric sensations in skin

Many physicians recommend tapering off of Zoloft rather than sudden discontinuation.  This may help minimize the withdrawal symptoms.

Common Side Effects of Zoloft

Zoloft also has a number of less-severe side effects which are related to serotonin.

Common side effects include:

  • Nausea
  • Diarrhea or constipation
  • Weight loss or gain
  • Dizziness and drowsiness
  • Insomnia and agitation
  • Sweating
  • Dry mouth
  • Headache
  • Sexual dysfunction (males and females)

Pfizer is facing a number of lawsuits related to Zoloft use.  Patients or loved ones of those harmed by Zoloft may be eligible for compensation for medical costs, lost wages and pain and suffering.

View Sources
  1. Butler, J., Leonard B. E. (October 1998). The Platelet Serotonergic System in Depression and Following Sertraline Treatment. International Clinical Psychopharmacology. Accessed on 25 June 2014. http://journals.lww.com/intclinpsychopharm/Abstract/1988/10000/The_Platelet_Serotonergic_System_in_Depression_and.5.aspx
  2. Chambers, C.D., et al. (9 February 2006) Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn. New England Journal of Medicine. Accessed on 25 June 2014. http://www.nejm.org/doi/full/10.1056/NEJMoa052744
  3. Flament, MF, Lane RM, Ying, Z. (September 1999). Predictors of an Acute Antidepressant Response to Fluoxetine and Sertraline. International Clinical Psychopharmacology. Accessed on 25 June 2014. http://www.ncbi.nlm.nih.gov/pubmed/10529069
  4. Food and Drug Administration. (30 June 2006). FDA Approves First Generic Sertraline. Accessed on 25 June 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108684.htm
  5. Harris, Gardiner. (2 September 2009). Pfizer Pays $2.3 Billion to Settle Marketing Case. The New York Times. Accessed on 25 June 2014. http://www.nytimes.com/2009/09/03/business/03health.html?_r=2
  6. Hostetter, A., Ritchie, J.C., Stowe, Z.N. (7 June 2007). Amniotic Fluid and Umbilical Cord Blood Concentrations of Antidepressants in Three Women. Biological Psychiatry. Accessed on 25 June 2014. http://www.biologicalpsychiatryjournal.com/article/S0006-3223%2800%2900958-6/abstract
  7. Judicial Panel on Multidistrict Litigation. (January 2012) Case 2342. Accessed on 25 June 2014. http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2342-Tag-Along-Transfer-12-13.pdf
  8. Louik, C., et al. (28 June 2007). First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects. New England Journal of Medicine. Accessed on 25 June 2014. http://www.nejm.org/doi/full/10.1056/NEJMoa067407
  9. Johnson, L. . (31 Jan 2013). Pfizer disputes claim against antidepressant. USA Today. Accessed on 25 June 2014. http://www.usatoday.com/story/news/nation/2013/01/31/pfizer-zoloft-lawsuit/1881441
  10. Mayo Clinic (2014) Antidepressants: Safe during pregnancy?. Mayoclinic.org. Accessed on 25 June 2014. http://www.mayoclinic.org/healthy-living/pregnancy-week-by-week/in-depth/antidepressants/art-20046420
  11. Mayo Clinic. (2014) Serotonin Syndrome. Mayoclinic.org. Accessed 25 June 2014. http://www.mayoclinic.org/diseases-conditions/serotonin-syndrome/basics/definition/con-20028946
  12. Moylan, T.(17 April 2013). Zoloft Birth Defects MDL Created, Assigned To Eastern District Of Pennsylvania. LexisNexis Communities. Accessed on 25 June 2014. http://www.lexisnexis.com/community/litigationresourcecenter/blogs/litigationblog/archive/2012/04/17/zoloft-birth-defects-mdl-created-assigned-to-eastern-district-of-pennsylvania.asp&xgt;.
  13. NAMI (May 2007). Zoloft Fact Sheet. College of Psychiatric and Neurological Pharmacists. Accessed on 25 June 2014. http://www.namihelps.org/assets/PDFs/fact-sheets/Medications/Zoloft.pdf
  14. NAMI (2014) Depression. Accessed 25 June 2014. National Institute of Mental Health. http://www.nimh.nih.gov/health/topics/depression/index.shtml
  15. NAMI (2014) Panic Disorder. Accessed 25 June 2014. National Institute of Mental Health. http://www.nimh.nih.gov/health/topics/panic-disorder/index.shtml
  16. Nordqvist, C. (1 February 2013). Zoloft No Better Than Dummy Pill, Says Lawsuit. Medical News Today. Accessed on 25 June 2014. http://www.medicalnewstoday.com/articles/255782.php
  17. Pfizer. Zoloft Medication Guide. Accessed on 25 June 2014. http://labeling.pfizer.com/ShowLabeling.aspx?id=517
  18. Quallich, George J. (18 March 2005). Development of the Commercial Process for Zoloft/sertraline. Chirality. Accessed on 25 June 2014. http://onlinelibrary.wiley.com/doi/10.1002/chir.20113/abstract
  19. RxList. Zoloft Drug Information. Accessed on 25 June 2014. http://www.nejm.org/doi/full/10.1056/NEJMoa052744
  20. Wagner, K.D., et al. (27 August 2003). Efficacy of Sertraline in the Treatment of Children and Adolescents with Major Depressive Disorder.. Journal of the American Medical Association. Accessed on 25 June 2014. http://jama.jamanetwork.com/article.aspx?articleid=197174
  21. Weller, I.V.(December 2004) Report of the CSM Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants. Accessed on 25 June 2014. http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con019472.pdf