Southern Med Law Is Evaluating SSRI Birth Defect Lawsuits Alleging Antidepressants Such as Zoloft and Paxil Cause Skeletal Defects, Heart Malformations, And Other Birth Defects When Taken During Pregnancy.
A newly released study suggests using antidepressants, such as Zoloft or Paxil, during the second or third trimester of pregnancy increases the risk of autism in children. Antidepressant medication has been the subject of SSRI birth defect lawsuits that allege drugs such as or Lexapro, Prozac and Celexa, can cause birth defects such as atrial septal defect, ventral septal defects, Persistent Pulmonary Hypertension of the Newborn, and skeletal defects such as spina bifida.
The study, published in JAMA Pediatrics Online on December 14, used a health insurance database that included 145,456 children born in Quebec between January 1, 1998 and December 31, 2009. Researchers from the University of Montreal found 1,054 children were diagnosed with autism. Of that total, boys with autism outnumbered girls by a ratio of about 4:1. Researchers also found children whose mothers took the most common form of antidepressants called, Selective Serotonin Reuptake Inhibitors (SSRI), during the second or third trimester were at an 87 percent higher risk for autism than children whose mothers did not take antidepressants.
“This research also supports previous studies that have found the use of antidepressants during pregnancy may increase the risk of birth defects,” says Dr. François Blaudeau, founder of Southern Med Law, who is both an attorney and practicing physician and has first-hand knowledge of how SSRI medications affect expectant mothers and their infants.
There are currently hundreds of birth defect lawsuits pending against the makers of Zoloft and Paxil. While an MDL has not been established for Paxil, there are currently over 500 Zoloft lawsuits are pending in the U.S. District Court, Eastern District of Pennsylvania. The SSRI birth defect lawsuits allege SSRI manufacturers knew their drugs could cause serious birth defects including club foot, spina bifida, and heart defects such as Persistent Pulmonary Hypertension Of The Newborn (PPHN), atrial septal defects and ventral septal defects, and that they failed to warn doctors and their patients about these potential dangers. (In re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation, MDL-2342)
SSRI is a class of drugs that increase the amounts of serotonin, a natural chemical in the brain that helps maintain brain functions such as mood and memory. The U.S. Food and Drug Administration (FDA) has raised concerns over SSRI antidepressants, such as Zoloft and Paxil due to the need to treat depression in pregnant women and the potential for the drugs to cause birth defects. In addition to depression, SSRIs are also prescribed to treat panic disorder, anxiety disorder, post-traumatic stress disorder and obsessive compulsive disorder.
A study published in February 2006 in the New England Journal of Medicine reported a sixfold increased risk of Pulmonary Hypertension of the Newborn (PPHN) in infants born to mothers who took an SSRI antidepressant in the last trimester of pregnancy. PPHN occurs when newborns have difficulties breathing outside the womb. In wake of the New England Journal of Medicine study, the FDA in July 2006, directed SSRI drug manufacturers to update the safety labels of their drugs to include a warning over the potential risk of PPHN in babies born to women who took SSRI medications after the 20th week of pregnancy.
[nejm.org/doi/full/10.1056/NEJMoa052744, New England Journal of Medicine, February 9, 2006)
Along with concerns over antidepressants and birth defects came complaints that one of the largest drug manufacturers worldwide, GlaxoSmithKline, was promoting its popular antidepressant drugs, Paxil and Wellbutrin, for unapproved uses. The U.S. Department of Justice Department (DOJ) accused the company of promoting Paxil for treating depression in children under 18, and promoting Wellbutrin for weight loss, and treating sexual dysfunction, substance addictions, Attention Deficit Hyperactivity Disorder and other off-label uses. In July 2012, GlaxoSmithKline agreed to plead guilty and pay $3 billion to settle the civil and criminal claims brought by the DOJ regarding Paxil, Wellbutrin and other prescription drugs.
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report, Department of Justice, July 2, 2012]
Southern Med Law representation men and women from around the country in negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. The firm led by Dr. François Blaudeau, an attorney and MD, the attorneys at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They are not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
Southern Med Law
Southern Institute for Medical and Legal Affairs
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