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Pfizer introduced Zoloft in 1991 as a selective serotonin reuptake inhibitor (SSRI) antidepressant. The drug generically known as sertraline has since been prescribed not only for depression but also for treatment for premenstrual dysphoric disorder, post-traumatic stress disorder, anxiety and panic disorders, and obsessive compulsive disorder.
However, as the drug was once considered a safer SSRI for pregnant women to take, doctors prescribed it until studies conducted over the past decade found this antidepressant may be associated with a wide range of birth defects.
Outside of pregnancy-related depression, Zoloft continues to remain one of the most-prescribed medications. The medication, regardless of the condition for which it is prescribed, is designed to balance a patient’s serotonin, which in turn elevates his or her mood. Nevertheless, even with this desired effect, patients have been known to experience a range of extreme side effects, from gastrointestinal bleeding to worsening depression to suicidal thoughts.
When prescribed to pregnant women experiencing depression, Zoloft has been associated with 20 types of birth defects:
- Respiratory distress: Specifically, babies are born premature with underdeveloped lungs, which lead to breathing difficulties. A child may also be born with neonatal adaptation syndrome (NAS), which is further associated with breathing complications.
- Heart defects: A child may be born with holes in the heart, which obstruct blood circulation. This isn’t the only heart-related defect associated with Zoloft, however; others include heart and atrial septal defects, ventricular defects, atrial enlargement, congenial heart defects, tetralogy fallot, and pulmonary stenosis. Complications have been known to increase when a mother is prescribed Zoloft in conjunction with Celexa.
- Anencephaly: Parts of a child’s brain are missing.
- Persistent Pulmonary Hypertension of the Newborn (PPHN): The FDA issued a warning regarding this condition’s correlation with Zoloft prescription in 2006. A child born with this condition cannot breathe independently outside of the womb and is often placed in intensive care with a ventilator.
- Anal atresia
- Omphalocele: As a result of a defect in abdominal muscle development, the intestines, liver, and other organs remain outside the body.
- Limb reduction defects
- Neural tube defects
- Club foot
- Truncus arteriosis
- Autism spectrum disorders
- Down’s syndrome
- Undescended testes
- Spinal bifida
- Skull defects
Because of one or more of the above defects, children often require multiple corrective surgical procedures during their first three years and later treatments and surgeries into adulthood.
Since the ’90s, Zoloft has been associated with instances of teens taking their own lives, and as a result, doctors prescribing this SSRI are required to watch child and adult patients for signs of worsening depression or suicidal thoughts and behavior.
However, suicide composes just one of several potentially-harmful side effects teens and adults may experience when prescribed Zoloft to treat depression or another condition:
- Hallucinations and delusions
- Decreased heart rate
- Homicidal thoughts
- Self harm
- Serotonin syndrome
- Sexual dysfunction
- Spontaneous abortion or miscarriage
Because of the potentially-extreme nature of Zoloft’s side effects, the FDA has required the SSRI to have a black box warning.
Along with the side effects from the antidepressant alone, Zoloft has been known to exacerbate certain conditions and to negatively react with other medications. Studies have shown a correlation between Zoloft usage and an increased risk of death when a patient has coronary artery disease. As well, the antidepressant has been associated with a 600-percent increase in stomach and intestinal bleeding when taken with aspirin or ibuprofen.
Filing a Lawsuit
While mothers given Zoloft during pregnancy, only to find their child has one or more birth defects, have been able to receive compensation for pain and suffering and future medical expenses, plaintiffs in these instances are advised to come prepared with medical and pharmacy records.
For patients experiencing any of Zoloft’s side effects, a class action lawsuit already began, with all cases compiled into the United States District Court in the North District of California, San Jose Division. The plaintiff’s cite the FDA’s claims that Pfizer did not publish results from its trial studies showing Zoloft was only minimally better than a placebo and that Pfizer used deceptive marketing practices in claiming this SSRI is “highly effective” in treating depression.