A new study appears to confirm the link between antidepressant use during pregnancy and a higher risk for autism spectrum disorder and some types of developmental delays – particularly in boys. The study looked at mothers who took a selective serotonin reuptake inhibitor (SSRI) while pregnant. SSRIs are a specific category of antidepressants that include medications like Zoloft, Paxil and Prozac.
Nearly 1,000 children studied
Researchers at Johns Hopkins Bloomberg School of Public Health looked at nearly 1,000 children in their study that was published in recent online and print issues of the journal Pediatrics. They found children diagnosed with ASD were more likely to have mothers that took an antidepressant like Zoloft while pregnant. The Zoloft autism risk appeared highest when the drug was taken during the first trimester and affected boys much more frequently than girls.
The children were all between the ages of two and five and were divided into three categories; those diagnosed with ASD, those with developmental delays and those with typical delays. The study found that boys diagnosed with ASD were three times more likely to have a mother that took an SSRI than children in the typical delay category. Exposure was also higher in boys diagnosed with developmental delays and seemed to be strongest when the drug was used during the last trimester of pregnancy.
Serotonin levels could explain cause and effect
While researchers did not find a definitive cause and effect between SSRI use and autism, it is possible that drugs that alter serotonin levels could impact development of the fetus. These findings could raise questions about whether an increase in SSRI use could correlate to a higher number of autism diagnoses in recent years. The Centers for Disease Control and Prevention estimates that 1 in 68 children born in the U.S. are diagnosed with autism, with five times more boys getting diagnosed than girls.
“This study provides further evidence that in some children, prenatal exposure to SSRIs may influence their risk for developing an autism spectrum disorder,” Irva Hertz-Picciotto, Ph.D., M.P.H., chief of the Division of Environmental and Occupational Health in the UC Davis Department of Public Health Sciences, told Science Daily. Dr. Hertz-Picciotto also emphasized the findings should prompt physicians to carefully weigh the risks between SSRIs and untreated depression during pregnancy.
Other Zoloft side effects in children
Zoloft autism risk is not the only birth-related concern surrounding SSRIs like Zoloft today. The antidepressant has also been linked to heart defects, gastrointestinal defects, cranial abnormalities and limb malformations. Zoloft may also increase the risk for a rare but serious congenital condition known as persistent pulmonary hypertension of the newborn or PPHN. In 2011, the FDA issued a safety communication warning that use of SSRIs like Zoloft could increase the risk for a PPHN diagnosis in a newborn child.
As concern over Zoloft side effects continues to mount, some parents have filed lawsuits against Zoloft manufacturer Pfizer. These parents claim they were not sufficiently warned about the risks Zoloft posed to their unborn children. They are now seeking damages for their children’s medical bills and other economic and non-economic losses.
Dozens of those lawsuits alleging serious birth defects have now been coordinated into multidistrict litigation in U.S. District Court for the Eastern District of Pennsylvania, where they are currently overseen by Judge Cynthia M. Rufe. Multidistrict litigation is established when there are a growing number of similar complaints against the same defendants, for the purpose of streamlining early trial proceedings.
An Alabama mother filed a Zoloft heart defects lawsuit on behalf of herself and her son, on April 9, 2014, in Alabama Southern District Court against the defendants Pfizer, Inc. and Greenstone, LLC.
Pfizer, Inc. is the designer, manufacturer, marketer, and distributor of Zoloft, the trade name for the antidepressant sertraline. Greenstone, a wholly owned subsidiary of Pfizer, Inc. is the designer, manufacturer, and distributor of sertraline.
Zoloft marketed as safe for pregnant women
Zoloft or sertraline was introduced to the market in 1991. It is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)—a class of drugs that has become highly popular because of its relative safety and minimal side effects when used as prescribed.
The SSRI class of antidepressants work by increasing the amounts of serotonin, a natural substance in the brain that helps maintain mental balance. Zoloft (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), post-traumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). It is also used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness.
Plaintiff alleges Zoloft caused her son permanent disfigurement and defects
The plaintiff’s lawsuit arises from her use of Zoloft during her pregnancy with her son who was born with a cleft palate, serious heart issues, and other congenital birth defects. The mother claims she ingested Zoloft in the manner and dosage recommended by Pfizer and Greenstone and as prescribed by her doctors. Her suit alleges however that both Pfizer and Greenstone concealed their knowledge of the dangerous side effects of Zoloft from herself, her physicians, the medical community, and other victims, even when used exactly as prescribed.
The claimant further alleges that the defendants, prior to her using Zoloft, knew of studies within the same class of drugs that mothers exposed to SSRI’s late in their pregnancy showed significantly higher rates of premature delivery and significantly lower birth height and weight, congenital birth defects, craniofacial defects such as cleft palate and cleft lip, limb defects such as club foot, and septal heart defects.
Pfizer never warned the public about Zoloft dangers, alleges mother
The most serious allegations in the suit revolve around Pfizer’s failure to adequately disclose the increased risk of congenital birth defects of Zoloft to the medical community and to the public. Pfizer was aware that its failure to do so would result in serious injury and/or death to the children or unborn fetuses of women who were prescribed Zoloft by a doctor who also was not aware of this information, claims the plaintiff.
The claimant is demanding general, special, and statutory damages from Pfizer and Greenstone to help compensate for her son’s permanent disfigurement and injuries.
There are currently over six hundred Zoloft lawsuits with the majority of claims centralized before US District Judge Cynthia Rufe in the Eastern District of Pennsylvania multidistrict litigation (MDL).
A recent study has found that Zoloft pregnancy side effects could include an increased risk of pre-term birth.The medical journal PLOS ONE published the study last month, which was conducted by researchers from a number of medical facilities and universities, including Brigham and Women’s Hospital.
Researchers found that women who took antidepressants during their second and third trimesters were more likely to go into labor and give birth prematurely. They examined information from a variety of medical databases and previous studies to come to this conclusion, noting that women taking these medications in their third trimester have a higher risk of pre-term birth.
The research team noted the possibility of the presence of residual confounding factors that were not ruled out of the study.
High cost of pre-term births
Pre-term birth rates are on the rise in the U.S. Children born prematurely experience higher infant mortality rates and have a stronger chance of suffering from significant health problems than those born at full-term. The estimated cost of pre-term birth injuries to the U.S. health care system is approximately $26.2 billion per year.
At issue is an increasing rate of pre-term births in the U.S. over the past 20 years. Such children suffer from higher infant mortality rates, and face a stronger chance of having significant health problems than peers born at full term. Preterm birth injuries are estimated to cost the U.S. health care system about $26.2 billion annually.
While the study does not name any specific class of antidepressants or mention any by name, popular SSRI antidepressants, such as Zoloft have been associated with serious birth defects.
A 2007 study published by the New England Journal of Medicine noted that women who ingested the drug during pregnancy had a 50 percent higher chance of giving birth to a child with heart defects. Some of the most commonly reported issues include persistent pulmonary hypertension of the newborn (PPHN) and septal defects such as ASD and VSD.
Zoloft is part of a category of drugs known as selective serotonin reuptake inhibitors (SSRIs). The drug is used to treat Obsessive-Compulsive Disorder, depression, Panic Disorder, Posttraumatic Stress Disorder, Social Anxiety Disorder, and Premenstrual Dysphonic Disorder. Other drugs in this class include medications such as Celexa, Lexapro, Luvox, Prozac, and Paxil.
The Zoloft multidistrict litigation was established on April 17, 2013, in the Eastern District of Pennsylvania, to centralize lawsuits during pre-trial proceedings to reduce the number of redundancies and help to minimize court costs.
Currently, more than 420 products liability cases have been filed under MDL 2342, under the direction of Judge Cynthia M. Rufe, but that number is expected to increase. Plaintiffs allege that Zoloft was the direct cause of their childrens’ congenital birth defects.
Zoloft has been used by tens of millions of patients. Many plaintiffs believe Pfizer, the manufacturer of the drug, knew it could cause harm to unborn children, but failed to warn patients and the medical community of the risks. They believe Pfizer misrepresented and continues to misrepresent the safety and efficacy of the drug.
Another Zoloft injury lawsuit has just been added to the multidistrict litigation (MDL) in federal court in Philadelphia. A Texas mother charges that her child was born in 2003 with life-threatening congenital birth defects due to the mother’s use of Zoloft during her pregnancy.
The mother asserts that the drug’s manufacturers, Pfizer and its subsidiary Greenstone, knew that Zoloft caused severe side effects in children whose mothers took the medication while pregnant. But defendants concealed that information from the mother, her treating physicians, and the FDA, the mother alleges. Had she been warned of the risks, the mother charges, she would not have used the drug during pregnancy.
Zoloft side effects in children
The FDA approved Zoloft to treat major depression in adults in 1991. It quickly became one of the most frequently-prescribed drugs in the United States, with over 39 million Zoloft prescriptions written in 2012. Many physicians prescribed Zoloft to women of child-bearing age, and continued to prescribe its use when those women became pregnant.
Some studies have shown that Zoloft use during pregnancy causes congenital birth defects. A study of nearly 500,000 children born in Denmark between 1996 and 2003 found that infants were more than three times as likely to be born with heart defects when their mothers used Zoloft while pregnant.
A 2007 study in the New England Journal of Medicine found that Zoloft use during pregnancy was associated with a variety of serious birth defects. Infants born to mothers who took the medication while pregnant were nearly twice as likely to suffer craniosynostosis (a growth defect of the skull that can affect brain development); twice as likely to be born with septal heart defects; and nearly six times as likely to be born with omphalocele (a birth defect in which the infant’s intestines stick out of the navel.)
In 2006, the New England Journal of Medicine published a study linking Zoloft during pregnancy to a birth defect called persistent pulmonary hypertension of the newborn (PPHN).
Zoloft injury lawsuits centralized under MDL
Over 420 Zoloft cases have now been centralized for pretrial handling in the MDL. The lawsuits charge that Pfizer knew that Zoloft use during pregnancy caused congenital birth defects, but failed to notify the FDA, the medical community, and women who became pregnant while taking the drug.
The lawsuits assert a number of claims against Pfizer, including:
- Failure to warn of Zoloft’s known dangers to developing fetus
- Defective design, manufacture, and marketing of Zoloft
- Negligence in Zoloft’s development, formulation, distribution and marketing
- Negligent design of Zoloft
- Fraud, misrepresentation, and suppression of adverse information regarding Zoloft’s dangers to developing fetus
- Breach of express and implied warranties
- Gross negligence and malice
- Negligent infliction of emotional distress
Plaintiffs seek compensation for pain and suffering, past and future medical expenses, loss of future earnings capacity, loss of consortium, and other losses. In addition, the victims allege that Pfizer acted with deliberate, wanton, willful, and conscious disregard for the safety of consumers. Accordingly, the lawsuits seek punitive damages from Pfizer.
This Zoloft injury lawsuit was filed by the Texas mother on February 27, 2014. The first trial in the Zoloft MDL is scheduled to begin October 28, 2014.