Sertraline hydrochloride, marketed as Zoloft, is an antidepressant used to treat major depression as well as obsessive-compulsive disorder, post-traumatic stress disorder, and panic and social anxiety issues. Zoloft, which was introduced into the market by Pfizer in 1991, is classified as a selective serotonin reuptake inhibitor (SSRI) antidepressant. SSRI medications are widely prescribed and are used more than any other drug to treat depression in the U.S. Other SSRI medications include Celexa and Lexapro, among others.
The Food and Drug Administration initially placed SSRI antidepressants including Zoloft in its pregnancy “Category C” class of medications. This pregnancy category means that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate well-controlled studies in humans. The Pregnancy categories measure the teratogenic effects a drug has on a fetus. Teratogenic means that a drug or other substance is capable of interfering with the development of a fetus.
Baby Jennifer had to undergo open-heart surgery before her first birthday. Her mother took Zoloft during her pregnancy with Jennifer, which had been touted as safe to use. Jennifer has spent much of her infant life in and out of hospitals.
Several studies have found significant associations between sertraline and specific birth defects. Scientists at Harvard and Boston University studied the link between birth defects and SSRI antidepressants, both as a class and individually, and published their results in the New England Journal of Medicine in 2007.
The researchers found that first trimester maternal use of sertraline was significantly associated with omphalocele, a defect that causes an infant's abdominal organs to protrude outside the body, and septal defects, defects in the walls that separate the chambers of the heart. Sertraline doubled the risk of septal defects and increased the risk of omphalocele by over five times.
Addison started turning gray after she was born. Her mother took the antidepressant Zoloft while pregnant. Right after Addison was born, she was rushed to a specialist who diagnosed her with a congenital heart defect called Total Anomalous Pulmonary Venous Return (TAPVR).
Read about Baby Addison's story
Generic Name: sertraline (or sertraline hydrochloride)
Drug Class: Selective serotonin reuptake inhibitor (SSRI) antidepressant
CAS Number: 79617-96-2
Zoloft is used to treat the following disorders:
- major depressive disorder (MDD)
- obsessive-compulsive disorder (OCD)
- body dysmorphic disorder (BDD)
- posttraumatic stress disorder (PTSD)
- premenstrual dysphoric disorder (PMDD)
- panic disorder
- and social phobia (social anxiety disorder, or SAD)
- The use of MAOIs intended to treat psychiatric disorders with Zoloft or within 14 days of stopping treatment with Zoloft is contraindicated because of an increased risk of serotonin syndrome.
- The use of Zoloft within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.
- Concomitant use in patients taking pimozide is contraindicated. Zoloft is contraindicated in patients with a hypersensitivity to sertraline or any of the inactive ingredients in Zoloft.
- sexual dysfunction
- dry mouth
- excessive sweating
- loss of appetite
- weight loss
- head pain
- stomach cramps
- feeling weak
- anxiety and nervousness
Serious Adverse Outcome:
Serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions. The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including Zoloft treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists.
Serotonin syndrome symptoms may include:
- mental status changes
- autonomic instability
- labile blood pressure
- neuromuscular aberrations
- and/or gastrointestinal symptoms
Zoloft carries the following Black Box warning on its label: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
Category C, which means there is no controlled data in human pregnancy studies but animal studies have shown adverse effects on the fetus.