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.
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.
Zoloft May Cause Injuries in Infants/Children
Zoloft Side Effects and Birth Defects in Children
More than 300 Zoloft birth defect lawsuits, including a class action, have been filed against Pfizer in various state and federal courts. Categorized as a selective serotonin reuptake inhibitor (SSRI), Zoloft was introduced in 1991 to treat anxiety, panic, post-traumatic stress, premenstrual dysphoric, social phobia, and obsessive-compulsive disorders. In 2007, the drug became the highest sold anti- depressant in the United States. However, research reports published in the recent years have highlighted that Zoloft side effects in pregnant mothers led to birth of children with life-threatening problems and deformities. Heart, lung, and cranial defects, abdominal problems, spina bifida, and a number of other malformations are common in children born to mothers prescribed with Zoloft during their pregnancy.
Zoloft Birth Defects
The FDA issued a public health advisory in July 2006 highlighting the potential association between Zoloft side effects and pulmonary hypertension in newborns. A number of reports published between 2002 and 2006 indicted Zoloft-class antidepressants for premature births, deformities in newly born, low APGAR scores, and other problems in pregnant women. The federal regulator updated its warning four months later forbidding administration of Zoloft-like SSRI antidepressants to women in 20th or more weeks of their pregnancy.
According to the FDA, the drugs can increase the risk of pulmonary hypertension in newborns by six times if administered to pregnant women. This was also confirmed in a January 2012 study published by Swedish researchers. The British Medical Journal published a study on Zoloft in September 2009 that warned of cardiovascular problems in babies born to mothers taking Zoloft during pregnancy. Two Danish studies made public in October 2009 and 2010 showed that Zoloft side effects during pregnancy caused withdrawal-like syndrome and delayed development in newborns. In July 2011, the Times magazine reported that children with autism were born to mothers who took Zoloft antidepressant drug during pregnancy.
The most reported birth defects caused by Zoloft side effects include,
- Heart defects and cardiovascular disorders, such as pulmonary hypertension, pulmonary stenosis, tetralogy of fallot, pulmonary atresia, abnormal gap between the right and left atria, congenital septal defect, heart valve disorders, and hypoplastic left heart syndrome.
- Arterial defects, including transposition of great arteries and compression of the aorta
- Neural tube defects
- Autism
- Skull defects, craniosynostosis
- Lip, oral, and palate cleft
- Rectum, anus, and abdominal wall malformation
- Spina bifida
- New born behavioral syndrome
Other Zoloft Side Effects
According to a new study published in the medical journal Neurology in October 2012, administration of Zoloft and similar SSRI antidepressants may result in the brain hemorrhage. Though the risk is low, it can cause problems for people prone to brain hemorrhage due to other drug side effects. Sertraline, the generic name of Zoloft, is found to have sexual side effects. The drug can cause arousal disorder and inhibit the ability to achieve orgasm. A study found as many as 67% of men experiencing ejaculation difficulties and about 40 % orgasm dysfunction during a Zoloft sexual side effect study. Women had inadequate lubrication and swelling of sexual organs.
The FDA mandates all antidepressants, including Zoloft, to carry a black box warning of suicidal tendency side effects in people aged less than 25 years. Abrupt discontinuation of Zoloft causes withdrawal syndrome in users. According to a research conducted by Emory University scholars and presented at the New Orleans meet of the American College of Cardiology in 2011, Zoloft-like antidepressants cause atherosclerosis in men, an important reason for increased risk of heart attack and stroke.
The Problem
Our firm is offering free nationwide case evaluations to families whose children were diagnosed with medical conditions at birth or shortly therafter when the mother ingested Zoloft during pregnancy. Specific birth defects include cardiac malformations (ASD, VSD, Left Hypoplastic Heart Syndrome, coarctation of the aorta, Tricuspid or Pulmonary Atresia, Pulmonary Stenosis, transposition of the great vessels or any other heart defect), neural tube defect, craniosynostosis, cleft lip, cleft palate, skeletal deformations, and club foot.
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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