Zoloft may cause birth defects when a woman takes it during pregnancy. If you or a loved one has given birth to a child with a birth defect and the mother took Zoloft during pregnancy, you may be entitled to financial compensation. The same is true for drugs Wellbutrin and Zyban.
Zoloft is prescribed for many purposes. Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder and others. Regardless of the reason of prescription, women who take this drug may experience a greater than average risk of infant child birth defects, including but not limited to heart defects, cleft palate, cleft lip, skeletal deformations and more. If your child experienced such a horrific side effect, please call our team of Zoloft lawyers today for a free case evaluation on how we can help.
First Birth Defect Trial Set
Zoloft Birth Defect Lawsuit: First Federal Trial Set for Oct 2014
The first of the hundreds of Zoloft birth defect lawsuits filed in various US federal courts is scheduled to go on trial in October 2014. More than 250 Zoloft lawsuits are consolidated at Pennsylvania east federal court of Judge Cynthia M. Rufe under the MDL provision. An order issued by Judge Rufe on February 25, 2013, has set a time line for selection and discovery that may culminate with the first trial starting on October 13, 2014.
More than 400 Zoloft birth defect lawsuits have been filed against Pfizer, claiming product liability and failure to warn expectant mothers about possible birth defects linked to its side effects. The plaintiffs include parents of children born with Zoloft birth injuries as well as many children suffering from Zoloft disability or malformations who have now turned adult. The lawsuits have sought to penalize Pfizer for marketing a drug without revealing its life threatening side effects and breaching consumer trust.
Zoloft Birth Defect Injuries: Research Reports
Zoloft was approved in 1991 to treat major depressive, stress, and obsessive-compulsive disorders. The drug went on to become a blockbuster for the manufacturer Pfizer until the FDA warning in November 2006 linked Zoloft side effects on pregnant women to persistent pulmonary hypertension in children born to them. The federal regulator received dozens of reports between 2002 and 2006 about children born with malformations to mothers treated with the anti-depressant during pregnancy.
A research report in the New England Journal of Medicine published in June 2007 was the first to highlight the danger of Zoloft birth defects, including permanent brain and heart problems. It was followed by a British Medical Journal report in September 2009 that warned about Zoloft side effect injuries impacting fetus in women less than three-month pregnant. It listed congenital heart problem in newborns as the most important Zoloft side effect injury.
In May 2012, a Tennessee Medicaid study result reported by American Journal of Obstetrics and Gynecology confirmed the above findings and cautioned that the birth defect Zoloft risk can increase by fivefold when the drug is administered to women in the sixth month of pregnancy.
In October 2012, a meta-analysis of more than 100 SSRI side effect studies brought out by the Human Reproduction journal highlighted a number of prenatal and neonatal injuries caused by Zoloft, such as miscarriage, pregnancy complications, congenital defects in vertebra, cranial defects, pulmonary hypertension, and neurobehavioral abnormalities.
According to the US National Academy of Science, pregnant women using Zoloft and similar antidepressants are more likely to give birth to children with impaired language development abilities. Such children are also at a greater risk of missing developmental milestones and remaining retarded.
Important Zoloft Birth Defect Injuries
Zoloft taken by pregnant woman may give birth to babies with one or more of the following birth defects:
- Congenital heart defects, including persistent pulmonary hypertension, pulmonary atresia, heart valve defect, pulmonary stenosis, transposition of great arteries, hypoplastic left heart syndrome, atrial and ventricular septal defect
- Congenital brain defects, cranial defects, under developed skull, mental retardation, language development problem, craniosynostosis, and autism
- Congenital neurological disorders
- Congenital face defects, such as lip, oral, and palate clefts
- Congenital limb defects, such as club foot, anus defect, rectum malformation
- Spina Bifida
- Neural tube and abdominal wall defects
About Zoloft
Our team of attorneys are currently reviewing potential Zoloft® lawsuits involving women who took these drugs during early pregnancy and whose children suffered adverse side effects, including heart defects and cleft lip/palate, among with others.
Manufactured by Pfizer, Inc., Zoloft® is generically known as sertraline hydrochloride and is a drug prescribed to treat major depression in adults, as well as obsessive-compulsive disorder, panic and social anxiety disorders and post-traumatic stress disorder in both adults and children. Zoloft is classified as a selective serotonin reuptake inhibitor (SSRI) drug, meaning that it selectively affects serotonin. Serotonin is one of many chemicals in the brain called neurotransmitters, which pass messages between nerve cells, and has been linked in various studiesto an increased risk of birth defects.
The Food and Drug Administration (FDA) initially placed SSRI antidepressants, including Zoloft, in its pregnancy Category C. This pregnancy category means that animal reproduction studies have shown an adverse effect on the fetus, but there have not yet been adequate and well-controlled studies in humans. 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, so there could be serious risks to the unborn baby of a woman taking Zoloft while pregnant.
Birth defects or conditions that may be associated with the use of Zoloft include:
- Abdominal wall defects (infant omphalocele)
- Anal atresia (complete or partial closure of the anus)
- Cleft lip and cleft palate
- Clubfoot (one or both feet turn downward and inward)
- Heart (cardiac) defects
- Skull defect (craniosynostosis)
Zoloft was approved by the FDA and introduced into the market in 1991. Prior to 2002, the drug was approved only for use in adults ages 18 and over. In 2002, the FDA approved Zoloft to treat severe obsessive compulsive disorder in children ages six and older.
The FDA issued a Public Health Advisory on Dec. 8, 2005, warning that use of certain antidepressants during the first trimester of pregnancy may be associated with an increased risk of birth defects. The advisory was based on U.S. and Swedish studies showing that exposure to certain antidepressants increased the risk of heart defects, including atrial and ventrical septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed.
Citing a study by Christina Chambers of the University of California, San Diego, that was published in the New England Journal of Medicine, Health Canada issued a strong warning in March 2006 to pregnant women or women who were trying to become pregnant that antidepressant drugs like Zoloft could potentially pose serious risks to unborn or even nursing babies.
A 2007 study published in the New England Journal of Medicine found a “significant association” between Zoloft and septal defects. A septal defect is a congenital defect that affects the structures of the heart. Septal defects can lead to the improper circulation of blood, making the heart work overtime. An atrial septal defect (ASD) is a hole in the wall between the heart’s two upper chambers. A hole in the wall between the two lower chambers is called a ventricular septal defect (VSD). Septal defects can be life threatening. According to the study, mothers who take Zoloft during pregnancy may double the risk of having an baby born with septal defects.
In another study published in the March 2010 issue of Pediatrics, researchers found a potential association between exposure to antidepressants in late pregnancy and a delay in normal motor development skills at six and 19 months of age. The same researchers, in a 2009 study published by British Medical Journal, found that women who were pregnant and taking certain antidepressants during the first trimester had an increased risk of giving birth to babies having various heart defects.
A recent study conducted by scientists at the University of Montreal and published online on May 31, 2010, in the Canadian Medical Association Journal suggests that women who take antidepressants like Zoloft during the first trimester of pregnancy are significantly more likely to suffer a miscarriage than women who do not take antidepressants.
The Archive of General Psychiatry published a report in July of 2011 linking SSRI antidepressants such as Zoloft to a potentially increased risk of autism spectrum disorders (ASDs) in babies born to mothers who took these drugs during the first trimester of pregnancy. Performed by researchers at the Kaiser Permanente Medical Care Program in Northern California, the population-based, case-control study compared a group of 298 children having varying degrees of autism and their mothers to another group of 1,507 randomly selected children and their mothers. Nearly 70 children from each group were exposed to antidepressants in the same class as Zoloft, and the researchers found a possible connection between mothers who took these drugs within a year before delivery and an increased the risk of their babies being born with ASDs. The highest risk was found to be among those whose mothers took these drugs during the first trimester.
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