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.
Were there omissions by Pfizer?
New Zoloft Birth Defect Class Action Says Pfizer May Have Misled Consumers
A Zoloft birth defect class action lawsuit filed in a California north district court on January 30, 2013 has accused Pfizer of breaching consumer trust and defrauding them of $30 billion by selling an antidepressant no better than a sugar pill. Laura A. Plumlee, the lead plaintiff, claiming that Zoloft does not offer any benefits and that she has brought this product liability class action “on behalf of consumers nationwide and in California, seeks to enjoin Pfizer’s continued unlawful conduct and recover damages for the millions of consumers who were tricked into purchasing a side effect-ridden drug that was, at best, marginally better than a sugar pill in treating depression.”
Plumlee took Pfizer’s Zoloft for a year without any benefit. Her doctor increased the dose by 8 times than originally prescribed to her, but without any advantage, and she finally switched to the generic version. She contends that a “vast majority” of clinical studies carried out in the past highlighted that Zoloft medication during trials did not improve the condition of patients suffering from depression and its effect was similar to that of a sugar pill.
The Zoloft class action lawsuits has also claimed that Pfizer used dishonest means, such as selective trial result publication and paid publications, to assert efficacy of Zoloft antidepressant. According to the petitioner, four of six clinical trials prior to the drug approval found Zoloft ineffective following design flaws, and the rest two declared it only marginally effective.
Zoloft Birth Defect Injury
Many research studies as well as post-marketing reports have highlighted congenital heart, brain, limb, abdominal, and face defects in children born to mothers treated with the antidepressant during their pregnancy. The FDA also issued a public warning in 2006, cautioning that the drug could result in women giving birth to babies with lasting pulmonary hypertension. According to a research paper made public by the US National Academy of Science, Zoloft and similar SSRIs taken during pregnancy may result in children missing post-natal development milestones.
A comprehensive study published in May 2012 by the American Journal of Obstetrics and Gynecology attributed premature birth, seizure, and congenital defects of newborns to the side effects of Zoloft taken during pregnancy. The October 2012 edition of Human Reproduction journal listed heart, brain, vertebra, abdominal, and lung birth defects, hypertension, neurobehavioral disorders, and limb defects in newborns as potential side effects of Zoloft therapy during pregnancy. The Times Magazine published a report in July 2011 that highlighted the likelihood of possible autism in newborns because of Zoloft use by expectant mothers.
More than 400 Zoloft birth defect lawsuits are pending for trial throughout the United States and the number is expected to go up as more parents and children with Zoloft injuries are coming forward. In January 2013, a Wisconsin couple filed a wrongful death lawsuit claiming that Zoloft side effects during pregnancy resulted in birth of their child with pulmonary dysplasia and brain malformations. The child died soon following these complications.
A similar Zoloft lawsuit filed by a Penn state couple claims that their daughter was born with heart problems and club foot due to Zoloft side effects. The mother took the drug during pregnancy, as she was unaware of its dangers. In June 2012, a 21-year-old Massachusetts woman sued Pfizer for her Zoloft injuries. She was born with atrial septal defects following the use of Zoloft by her mother during pregnancy.
Other Zoloft Side Effect Injury
A study funded by the National Institutes of Health and endorsed by the American College of Cardiology in April 2011 indicates that Zoloft side effects can cause fat deposition in carotid artery with the potential to disturb blood flow to the brain and neck. This may result in heart attacks and brain stroke. According to a research report published in the Frontiers in Evolutionary Psychology in April 2012, Zoloft-class SSRIs can cause miscarriage, hypertension, infertility, dyskinesia, seizures, respiratory arrest, cognitive disorder, stroke, bleeding problems, and brain neuron death among their side effects.
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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