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About Zoloft

Zoloft pill bottlesZoloft was launched by manufacturer Pfizer in 1999. At the time, the company touted the benefits of their antidepressant, marketing it as safer compared to older drugs like Prozac. The risk of potential side effects was downplayed in product marketing, allowing Zoloft to become one of the best-selling products for Pfizer in just six short years.

By 2005, more than 25 million prescriptions had been written for Zoloft, grossing the company almost $2.6 billion. During that time, Zoloft became the most prescribed antidepressant in the United States. Unfortunately, thousands of patients argue that Pfizer failed to warn about a potentially dangerous link between Zoloft and pregnancy complications, including life-threatening birth defects in children born to women who took the medications during pregnancy.

Zoloft overview

Zoloft is a type of selective serotonin reuptake inhibitor, also known as SSRIs. These medications work by inhibiting the absorption of serotonin, a neurotransmitter that affects sleep cycles and moods. By preventing the absorption of serotonin by the body, SSRIs can elevate mood and relieve some of the symptoms linked to depression.

SSRIs became a popular method for treating depression by the 1980s, when Prozac first hit the market. The drug quickly gained popularity due to claims that it caused fewer side effects than other types of antidepressants. The drugs are used to treat a wide range of disorders, from premenstrual dysphoric disorder (PMDD) to major depressive disorders (MDDs).

How Zoloft is used

Similar to other antidepressants in the SSRI class, Zoloft is used to treat a wide range of disorders. The primary use is to address symptoms of MDD. This disorder affects an estimated 7% of the total population in the U.S. Symptoms of the disorder might interfere with work, sleep and the ability to enjoy daily activities. The disorder is very serious and carries a nearly 20% suicide rate if it is left untreated.

Symptoms of MDD include:

  • Feelings of hopelessness or worthlessness
  • Feelings of sadness
  • Loss of interest in daily activities
  • Difficulty concentrating
  • Changes in sleeping or eating
  • Suicidal thoughts or ideations

Zoloft is also prescribed for the following disorders:

  • Obsessive-compulsive disorder (OCD)
  • Post-traumatic stress disorder (PTSD)
  • Premenstrual dysphoric disorder (PMDD)
  • Panic disorder
  • Social anxiety disorder

Zoloft and pregnancy risks

As Zoloft continues to be a popular choice among antidepressants, concerns over Zoloft side effects during pregnancy have surfaced. The antidepressant is categorized by the FDA as a class “C” medication, which indicates that research on animals has found a potential link between use during pregnancy and harm to the fetus. Unfortunately, human studies to support these findings are few and far between at this time. While this does not indicate that human pregnancies are not at risk, it does make it difficult for pregnant women and their doctors to accurately assess the safety of Zoloft during those nine months.

Zoloft studies that have been performed on human subjects suggest that women who take the SSRI after the 20th week of pregnancy have a greater likelihood of having their newborns diagnosed with a serious condition known as persistent pulmonary hypertension of the newborn, or PPHN. This relatively rare heart and lung condition is fatal in about 10% of the newborns who are diagnosed with the disorder. In 2011, the FDA issued a warning about the increased threat of PPHN in newborns born to mothers who take sertraline during the second half of their pregnancies.

Studies have also suggested an increased risk for some types of heart defects in babies born to women who took Zoloft during the early months of pregnancy. Researchers have found an increased incidence of septal defects in these babies, with the largest risk appearing in women who took more than one SSRI during their pregnancy.

Because of these concerns, women who are pregnant or intend to become pregnant should speak with their doctors about the risks of taking Zoloft or another SSRI while expecting. Taking the drug during pregnancy may increase the odds of a variety of birth defects. It may also lead to severe withdrawal symptoms in the newborn shortly after birth.

Allegations of Zoloft birth defects

A number of birth defects have been associated with Zoloft use during pregnancy.

Alleged Zoloft birth defects include:

  • Heart Defects – Both atrial septal defects (ASDs) and ventricular septal defects (VSDs) have been linked to Zoloft use. These defects are characterized by holes in the walls separating the chambers of the heart and may require surgical repair. Some defects may be fatal if left untreated.
  • PPHN – Persistent pulmonary hypertension in the newborn is a condition that leads to heart murmurs, low oxygen levels, rapid heart rate and rapid breathing. In some cases, the condition may progress to respiratory distress, which requires emergency medical treatment. Babies born with this condition may suffer permanent lung damage, developmental delays, hearing problems and seizures.
  • Craniosynostosis – This birth defect is characterized by a skull malformation that can impact brain development. The condition may lead to developmental delays and seizures. Surgical repair is the only known treatment at this time.
  • Omphalocele – Also referred to as an umbilical hernia, this birth defect results in the formation of certain abdominal organs outside the body. Surgical repair is the only possible treatment for omphalocele.
  • Club Foot – Malformations of the limbs, such as club foot, have also been linked to Zoloft use during pregnancy. This condition, also referred to as congenital talipesequinovarus or CTEV, occurs when the foot faces downward or inward, impairing the mobility of the child. Surgical intervention is often required for this birth defect.

More Zoloft side effects

SSRIs may be linked to fewer side effects than other antidepressant drugs, but there are still a few to worry about.

Zoloft side effects might include:

  • Headache or dizziness
  • Nausea and diarrhea
  • Dry mouth
  • Restlessness or insomnia
  • Tremors
  • Sweating
  • Unexplained weight gain or loss
  • Suicidal thoughts
  • Sexual dysfunction

Zoloft and the FDA

Since it was first released in 1999, Zoloft has been the subject of a number of FDA warnings and safety communications.

FDA alerts involving Zoloft include:

  • Black Box Warning, October, 2004 – Warning regarding Zoloft use in children and increased suicide risk
  • Public Health Advisory, July, 2006 – Alert to risk of serotonin syndrome, an overdose of serotonin that may occur when Zoloft is taken in combination with Triptan drugs prescribed for migraines
  • Public Health Advisory, July, 2006 – Second advisory involving the link between Zoloft and birth defects, particularly PPHN
  • Upgraded Warning, May, 2007 – Warning about suicide risk updated to include all users under the age of 25
  • Drug Safety Alert, December, 2011 – Safety communication alerting the public that the link between Zoloft and PPHN was still being evaluated.

Zoloft lawsuits

Women who believe Zoloft use during pregnancy led to birth defects in their newborn children may have grounds for legal action. Those who have filed complaints against manufacturer Pfizer allege the company did not adequately warn women and medical providers about the risks associated with use of the drug during pregnancy. In some cases, these plaintiffs are dealing with birth defects that will affect their children for the rest of their lives.

Some plaintiffs have also alleged that adverse Zoloft side effects include suicidal ideation and increased depression.

Federal Zoloft lawsuits alleging birth defects have been coordinated into multidistrict litigation in the Eastern District of Pennsylvania. Multidistrict litigation was established to streamline early trial proceedings for multiple cases with similar allegations. Currently, the federal MDL has amassed more than 200 lawsuits, with the possibility of more plaintiffs joining the MDL in the future.

  1. FDA, FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies,
  2. U.S. District Court, Eastern District of Pennsylvania, MDL No. 2342,
  3. WebMD, Antidepressants Linked to Birth Defect,
  4. British Medical Journal, Selective Serotonin Reuptake Inhibitors in Pregnancy and Congenital Malformations: Population Based Cohort Study,
  5. National Institute of Mental Health, What is Depression?