In humans, the function of the right side of the heart is to collect de-oxygenated blood from the body in the right atrium and pump it, via the right ventricle, to the lungs so that the exchange of carbon dioxide and oxygen can take place. In turn, the left side of the heart collects oxygenated blood from the lungs into the left atrium and moves it into the left ventricle, where it is pumped out to the rest of the body. In order for the heart to work properly and for it to deliver the blood and oxygen the body needs to function and survive, all the structures of the heart must form properly during fetal development. Unfortunately, studies have shown that babies exposed to certain pharmaceutical drugs during pregnancy may be at risk for developing severe malformations affecting the atria and ventricles. If you took a medication while pregnant, and your child was born with an atrial septal defect or a ventricular septal defect, contact a qualified birth defect attorney to discuss your legal options.
An atrial septal defect (ASD) is a congenital birth defect characterized by a hole in the wall separating the right and left atria in the heart. In children born with atrial septal defects, blood is permitted to flow from the left to the right atria, which causes pressure in the lungs to build up. Some atrial septal defects are minor and cause very few problems throughout the child’s life. In cases of severe ASDs, the increased pressure on the right side of the heart may cause blood to flow from right to left instead, which can result in significant shortness of breath. Other symptoms of ASDs include:
A ventricular septal defect (VSD) is a heart defect in which there is a hole in the wall that separates the heart’s right and left ventricles. VSDs are one of the most common types of congenital heart defects, and can occur on their own or with other congenital diseases. In some cases, babies with ventricular septal defects may have no symptoms, and the hole may even close on its own as the wall continues to grow after birth. If the VSD is large however, too much blood will be pumped to the lungs, which can lead to heart failure. Common symptoms of VSD include:
If the defect is small, children born with an ASD or VSD may require little to no treatment, and may live a normal lifespan without symptoms. If the defect is large however, surgery is typically required to close the hole in the wall of the heart. Unfortunately, even with treatment, some children born with an atrial septal defect may suffer from complications like stroke, heart failure, arrhythmias and pulmonary hypertension. In children suffering from a ventricular septal defect, serious complications like heart failure, delayed growth and development, infective endocarditis, pulmonary hypertension, and aortic insufficiency may occur.
In many cases of atrial septal defects and ventricular septal defects, the exact cause of the congenital malformation is unknown. However, a number of studies published in recent years have identified a potential connection between the use of certain pharmaceutical drugs during pregnancy and an increased risk of devastating birth defects in babies, including septal defects and other heart birth defects. According to research, women who take the following medications while pregnant may have a higher risk of giving birth to babies with ASDs or VSDs:
October 2009 – A jury awards $2.5 million in damages to the family of a young boy who was born with two “hole in the heart” birth defects after being exposed to Paxil during pregnancy.
July 2012 – Depakote lawsuits are filed by 27 women who claim that their use of Depakote in pregnancy caused their children to be born with congenital malformations.
January 2014 – A Depakote lawsuit filed in the U.S. District Court for the Southern District of Illinois alleges that Abbott Laboratories failed to adequately warn the public about the alleged risk of birth defects from Depakote.
July 2014 – Thirteen lawsuits are brought against Pfizer over birth defects allegedly caused by use of Zoloft during pregnancy.
February 2015 – A Minnesota woman files a Zofran lawsuit alleging that the anti-nausea drug caused her two children to be born with heart birth defects.
February 2015 – Exposure to Zofran in utero caused a baby to be born with three heart defects and other congenital malformations, according to a Zofran lawsuit filed in Massachusetts.
April 2015 – A woman from Texas files a federal lawsuit against GlaxoSmithKline, alleging that exposure to Zofran caused her child to be born with several malformations, including heart birth defects.
June 2015 – A Philadelphia jury recommends that changes be made to the Zoloft warning label to include information about the possible link between Zoloft use in pregnancy and birth defects in babies.
June 2015 – A trial begins in Philadelphia involving a girl who was born with serious heart malformations after being exposed to Zoloft during pregnancy.
December 2005 – A public health advisory issued by the FDA warns that use of the antidepressant Paxil during pregnancy may increase the risk of congenital malformations in babies, particularly the risk of heart birth defects.
July 2006 – The FDA adds a black box warning to the Depakote label warning consumers and the medical community that use of the anticonvulsant drug during pregnancy may cause birth defects in babies.
December 2009 – A drug safety communication issued by federal regulators indicates that babies exposed to Depakote in pregnancy may have an increased risk of suffering heart birth defects and other congenital malformations at birth.
Data from the North American Antiepileptic Drug Pregnancy Registry (NAAED) suggests that epileptic women who take Depakote during pregnancy may be four times more likely to give birth to babies with cardiovascular malformations and other birth defects, compared to epileptic women who take other anticonvulsant drugs during pregnancy.
August 2006 – The journal Neurology publishes research indicating that about 20.3% of pregnant women who took Depakote experienced adverse outcomes related to the birth of their children, compared to only 1% to 10.7% of pregnant women taking similar medications.
July 2009 – Research published in the journal Reproductive Toxicology establishes a potential connection between the use of Depakote in pregnancy and a three-times increased risk of birth likes, including cardiac malformations.
January 2010 – The American Journal of Nursing publishes research indicating that babies exposed to SSRI antidepressants during pregnancy are nearly twice as likely to develop serious heart malformations, including “hole in the heart” birth defects like atrial and ventricular septal defects.
June 2010 – Babies exposed to Depakote in utero may face a significantly increased risk of developing six different birth defects, including atrial septal defects, according to a study published in the New England Journal of Medicine.
July 2010 – A report from the UK Epilepsy and Pregnancy Register and the European and International Registry of Antiepileptic Drugs in Pregnancy indicates that babies exposed to Depakote and other valproate-based anticonvulsant drugs in pregnancy are more than twice as likely to suffer major birth defects.
February 2013 – The New England Journal of Medicine publishes a study involving more than 600,000 pregnancies in Denmark, and finds that Zofran use among pregnant women increases a baby’s risk of septal defects by 22%, ventricular septal defects by 41% and atrioventricular septal defects by 400%.
March 2013 – Research published in the journal Acta Neurologica Scandinavica indicates that Depakote use during pregnancy may be associated with serious congenital malformations, including heart birth defects.
August 2013 – A register-based nationwide cohort study indicates that pregnant women who take Zofran are two- to four-times more likely to have a baby with a septal cardiac defect.
December 2013 – Research published in the journal BioMed Research International analyzes all births in Western Australia between 2002 and 2005, and finds a 20% increased risk of major birth defects with first trimester exposure to Zofran.
June 2014 – A report by the Toronto Star identifies 20 instances of children born with birth defects like heart murmurs, heart attacks and atrial septal defects after being exposed to Zofran in utero.
June 2014 – The New England Journal of Medicine publishes research showing that women who take antidepressant drugs during the first trimester of pregnancy have a higher risk of giving birth to babies with heart birth defects.
October 2014 – In a study involving 1,501,434 babies born to women in Sweden who took Zofran while pregnant, 34% were born with cardiovascular defects, and 24% suffered cardiac septum defects. According to the researchers, babies exposed to Zofran in utero have a 62% increased risk of experiencing a cardiovascular defect, and a 200% increased risk of suffering a septal cardiac defect.
January 2015 – The American Journal of Obstetrics & Gynecology publishes a study linking Zoloft use in pregnancy to a 34% increased risk of “hole in the heart” birth defects.
The potential for prescription medications like Depakote and Paxil to cause severe birth defects in babies exposed to the drugs in utero is a major public health concern, as millions of pregnant women in the United States are prescribed these medications every year. Unfortunately, when drug manufacturing companies are not truthful about the possible health risks associated with their products, the consequences can be devastating for affected babies and their families. As a result of birth defects allegedly caused by the use of defective medications among pregnant women, families across the United States are filing claims against the makers of certain pharmaceutical drugs, alleging that they:
Heart defects are one of the most common types of birth defects affecting children, and are also the leading cause of birth defect-related death among infants. If you or a loved one has suffered from an atrial septal defect or ventricular septal defect, and you believe a defective medication to be the cause, contact an experienced birth defect attorney today for legal help. You may be entitled to financial compensation for your injuries, medical expenses, and pain and suffering, which you can collect by filing a product liability lawsuit against the drug manufacturing company. By hiring an experienced birth defect lawyer to represent your case, you can protect your legal rights and seek fair and timely reimbursement for your losses.