Antidepressant medications have rapidly become some of the most commonly prescribed drugs on the market in the United States, and although they were initially designed to treat the symptoms of depression, the FDA has approved many antidepressants for the treatment of additional psychiatric disorders, and some are even used for off-label purposes. Since Zoloft was first approved by the FDA in the early 1990s, it has quickly climbed to the top of the list of antidepressant drugs, and in 2007, Zoloft was the most frequently prescribed antidepressant on the U.S. market, with 29.7 million prescriptions filled. However, a growing body of research has linked Zoloft and other SSRI antidepressant drugs to an increased risk of congenital malformations among babies exposed to the medications in utero. If you believe your child has been harmed by side effects of Zoloft, contact a reputable Zoloft attorney today to discuss the possibility of filing a birth defect claim against Pfizer.
Zoloft and similar SSRI antidepressant drugs have been used to control depression and other psychiatric disorders since the early 1980s, and today, they are the most prescribed class of antidepressant on the market in the United States. SSRIs are popular largely because they are associated with fewer side effects than other types of antidepressants. However, a number of studies have examined the potential connection between Zoloft use in pregnancy and an increased risk of devastating birth defects in babies. Fortunately, there are alternative treatments available for depression and certain behavior disorders among pregnant women and women of childbearing age, including the following natural options:
Zoloft belongs to a class of prescription antidepressant drugs called SSRIs, or selective serotonin reuptake inhibitors, which function by restoring the balance of serotonin in the brain, a neurotransmitter responsible for controlling mood. The active ingredient in Zoloft is sertraline, and since it was approved by the FDA in 1991, the antidepressant drug has been approved to treat major depression, panic disorder, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, and premenstrual dysphoric disorder. Although Zoloft was only originally approved to treat adults ages eighteen and older, the FDA approved the drug in 2002 for the treatment of severe obsessive-compulsive disorder in children ages six and older. Zoloft is currently manufactured by Pfizer, Inc. and can be found in 25mg, 50mg and 100mg tablets for oral consumption.
Regardless of the popularity of Zoloft and other SSRI antidepressants, a number of recent studies have identified the use of these drugs during pregnancy as a possible risk factor for the development of major birth defects among infants. Included among these alleged Zoloft birth defects are:
While some of these birth defects are relatively minor, like cleft lip and cleft palate, and can typically be corrected with surgery, others are more serious and may even be life-threatening. Persistent pulmonary hypertension of the newborn (PPHN), for example, is a severe heart and lung condition in which a child’s circulation continues to bypass the lungs after birth, depriving the rest of the body of its supply of oxygen. Neural tube birth defects like spina bifida and anencephaly can also lead to devastating complications and may even result in death in some cases.
In 2006, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of PPHN among infants exposed to SSRIs like Zoloft in utero. This decision came on the heels of a New England Journal of Medicine study in which researchers found a six-times increased risk of PPHN among infants whose mothers took an SSRI like Zoloft after the twentieth week of pregnancy, compared to infants whose mothers took no antidepressants while pregnant. According to researchers, up to twelve out of 1,000 infants involved in the study were born with PPHN, compared to the expected rate among the general population, which is one to two out of 1,000.
In 2007, the NEJM published two additional studies in which researchers sought to examine the adverse effects of fetal exposure to SSRI antidepressants like Zoloft. According to the first study, infants born to women who took an SSRI drug during the first trimester of pregnancy were nearly twice as likely to develop birth defects like limb defects, club foot and anal atresia. Researchers also found a possible connection between these drugs and cleft palate, cleft lip and neural tube birth defects. The second study indicated that infants whose mothers took an SSRI like Zoloft while pregnant were more than twice as likely to be born with devastating birth defects like omphalocele, craniosynostosis and anencephaly.
Another study published in 2010 in the American Journal of Nursing determined that infants exposed to SSRI antidepressants during pregnancy were nearly twice as likely to be born with serious heart defects, particularly “hole in the heart” malformations like atrial septal defects and ventricular septal defects. According to the Journal of Nursing report, the prevalence of septal heart defects among infants whose mothers took an SSRI was 0.9%, compared to the prevalence among unexposed infants, which was 0.5%.
A number of parents in the United States have begun filing birth defect lawsuits against Pfizer, on behalf of babies born with cleft lip, cleft palate, heart malformations and other serious birth defects after being exposed to Zoloft during pregnancy.
June 16, 2015 – For the second time in two months, a judge ruled in favor of Pfizer in a trial involving the drug maker’s alleged failure in providing adequate warnings about the risk of birth defects associated with Zoloft use in pregnancy.
June 8, 2015 – A Philadelphia jury was presented with documents indicating that scientists warned Pfizer executives about a possible connection between Zoloft and birth defects in babies, and recommended changes be made on the drug’s warning label to reflect this risk.
June 1, 2015 – A trial begins in Philadelphia on behalf of a girl who was born with serious heart defects after being exposed to Zoloft in utero.
April 20, 2015 – A St. Louis jury ruled in favor of Pfizer in a trial accusing the drug company of boosting profits by downplaying the risk of heart defects from Zoloft use in pregnancy.
April 9, 2015 – Trial begins in the first lawsuit filed over Zoloft birth defects, which accuses Pfizer of failing to warn women about the risks associated with becoming pregnant while taking the SSRI antidepressant.
July 25, 2014 – Thirteen new lawsuits are brought against Pfizer by women who gave birth to babies with major birth defects after taking Zoloft while pregnant.
March 6, 2014 – A joint status update issued by U.S. District Judge Cynthia M. Rufe indicates that there are 586 Zoloft birth defect lawsuits pending in the federal MDL, and dozens more pending in state courts in New York, California, Alabama, Missouri and Illinois.
January 14, 2013 – A Wisconsin family files a wrongful death lawsuit against Pfizer, on behalf of their child, who died of birth defects allegedly associated with Zoloft use in pregnancy.
September 5, 2012 – A Zoloft birth defect lawsuit is filed on behalf of a child who was born with a club foot and a life-threatening heart defect called truncus arteriosus after being exposed to Zoloft in utero.
The FDA has classified Zoloft as a pregnancy category C medication, which means the drug may cause harm to a human fetus when taken during pregnancy. The FDA has also required all sponsors of SSRI antidepressants to change drug prescribing information to include the potential risk for PPHN. If you are currently taking Zoloft and you are pregnant or planning to become pregnant, consult your physician immediately. It may be dangerous to suddenly discontinue use of a prescription medication, as this may cause further harm to you or your child. However, with the help of your doctor, you may be able to find a safer alternative to Zoloft for treating your medical condition.
Over the past decade, numerous studies have been conducted by researchers from all over the world, detailing the possible health risks of SSRI antidepressant drugs, including the alleged increased risk of birth defects from Zoloft use in pregnancy. The following are some of the most recent Zoloft birth defect studies:
January 30, 2015 – A study published in the American Journal of Obstetrics & Gynecology draws a connection between the use of Zoloft during pregnancy and a 34% increased risk of “hole in the heart” birth defects and a two-times increased risk of a severe skull malformation called craniosynostosis.
June 19, 2014 – Research published in the New England Journal of Medicine indicates that women who use antidepressant drugs during the first trimester of pregnancy are more likely to give birth to a baby with a heart malformation.
April 29, 2014 – Patients aged 10-24 who are administered high-dose antidepressant drugs like Zoloft may face double the risk of suicidal behavior, according to research published in JAMA Internal Medicine.
October 19, 2012 – A study published in the medical journal Neurology warns that Zoloft treatment may be associated with potentially life-threatening side effects like gastrointestinal bleeding, bleeding in the brain and stroke, especially among patients taking Pradaxa, warfarin and other blood thinner medications.
Researchers and federal regulators have warned for years that SSRI antidepressants like Zoloft can potentially cause severe birth defects in babies exposed to the prescription drugs during pregnancy. In spite of the alleged risk of birth defects from Zoloft, the antidepressant drug has brought in billions of dollars for Pfizer, and by 2005, Zoloft was the most prescribed antidepressant available, with more than 27 million prescriptions filled and $3.3 billion in sales. Zoloft lawsuits brought against Pfizer allege the following:
Defective drug lawsuits are important not only because they help injured victims collect the compensation they deserve, but also because they bring public attention to the importance of safe medications and the need for more stringent regulations on the dangerous drugs already on the market. Victims of serious injuries associated with the proper use of a defective medication are not at fault, and should not be held accountable for the resulting consequences. If you or a loved one has suffered from a severe birth defect, and you believe Zoloft to be the cause, contact a knowledgeable Zoloft lawyer today to discuss your legal options. You may have grounds to file a Zoloft lawsuit against Pfizer in order to seek financial compensation for your injuries, the medical expenses associated with injury treatment, and the pain and suffering endured by you and your family.