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Zoloft May Cause Birth Defects When Taken During Pregnancy

Gabriel Assaad
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Partner and attorney at Kennedy Hodges LLP practicing personal injury, medical malpractice & product liability

Zoloft is a drug commonly prescribed to treat anxiety and depression. Used by millions of Americans today, it has been touted as a safe and effective way to combat a number of mental illnesses. Recently, however, there have been questions regarding the drug’s safety for use by pregnant women. Research has linked the drug to several serious fetal issues, and hundreds of lawsuits have been filed claiming Zoloft caused birth defects when taken during pregnancy.

Zoloft Promoted as a Safer Antidepressant

Zoloft, known by the generic name sertraline, was first marketed in England under the name Lustral. It was introduced in the U.S. in 1991 and marketed as a safer alternative to Prozac. Both drugs are selective serotonin reuptake inhibitors (SSRIs)—a class of antidepressants that work by affecting serotonin levels in the brain. Specifically, they block the absorption of the chemical, which changes the balance of the serotonin and helps boost mood.

Pharmaceutical company Pfizer claims Zoloft is as effective as other SSRIs but with fewer withdrawal symptoms and side effects. The U.S. Food and Drug Administration (FDA) approved the drug for depression, anxiety, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, and premenstrual dysphoric disorder. It was the second most prescribed psychiatric medication in 2013, with prescriptions written for over 41 million Americans.

However, the FDA labeled Zoloft a category C drug. This means the drug has proved harmful to animals in laboratory models, but there have been no “adequate and well-controlled studies in pregnant women.” In 2006, the FDA first warned of a possible link between SSRIs and birth defects and issued a warning for pregnant women, noting that studies suggested the drug may be tied to health issues for newborns. At that time, the FDA advised physicians to “carefully consider and discuss with patients the potential risks.”

Possible Risks for Infant Birth Defects

Though no human testing has been done, researchers reviewed cases in which women have taken Zoloft during pregnancy and claim some links to birth defects. In addition to irritability, poor feeding, and sleep disturbance in the baby, more serious issues have been named:

  • Persistent pulmonary hypertension of the newborn (PPHN). This condition decreases the body’s supply of oxygen. A Nordic study states that PPHN can be twice as likely when the mother takes an SSRI.
  • Anencephaly. This is a serious condition in which babies are born without parts of the brain and skull. A neural tube defect, anencephaly is fatal in nearly every case.
  • Atrial Septal Defect (ASD). ASD is a heart defect where a baby has a hole in between the chambers of the heart. This defect results in increased blood flow through the lungs and can damage blood vessels, causing high blood pressure, heart failure, and other problems.
  • Hypoplastic left heart syndrome. This condition affects blood flow through the heart. The left side of the heart cannot adequately pump oxygen to the body due to malformations.
  • Tetralogy of Fallot (TOF). TOF is a combination of congenital heart defects. It occurs when four defects develop together: ventricular septal defect, pulmonary stenosis, enlarged aortic valves, and ventricular hypertrophy. This can cause a number of issues, including irregular heartbeat, infection in the layers of the heart, fainting or seizures, and delayed development.
  • Omphalocele. This is a defect of the abdominal wall. A hole in the belly allows the intestines, liver, and possibly other organs to stick outside of the body.
  • Cleft lip or cleft palate. This condition occurs when the baby’s lip or mouth does not form properly. This leaves an opening in the lip or in the roof of the mouth and requires surgery to repair.

Lawsuits Seek Compensation From Pfizer

Starting in 2012, lawsuits have been filed across the country claiming Pfizer did not adequately warn women taking Zoloft of potential risks to an unborn child. The lawsuits have been brought by parents of babies born with birth defects after the mother took Zoloft during her pregnancy. The parents argue that Pfizer did not include information from its internal research that the drug could cause birth defects, and women not on birth control should be made aware of the possible dangers. Drug companies are obligated by law to report any risks to the consumer.

Based on the number of lawsuits, the courts have combined the cases in multidistrict litigation (MDL). In MDL, complex cases that share a similar issue are transferred to one court. Unlike class action suits, the outcome of one trial does not affect the outcome of any of the other cases. Currently, there are over 200 pending cases.

If your baby was born with a birth defect, and you took Zoloft during your pregnancy, you may be entitled to make a claim. Contact the experienced legal team at Kennedy Hodges at 888-526-7616 for a free consultation.