Anti-Depressants/Selective Serotonin Reuptake Inhibitors (SSRIs)
Selective serotonin reuptake inhibitors (SSRIs) are the most common medications used to treat depression, anxiety, and certain personality disorders. SSRIs include medications such as Celexa, Lexapro, Luvox, Paxil, Pristiq, Prozac, and Zoloft. Similar to SSRIs are serotonin-norepinephrine reuptake inhibitors (SNRIs) such as Effexor and Cymbalta. SNRIs are also prescribed to treat depression and anxiety.
Sales of antidepressants in the United States surpassed $11 billion in 2010. Antidepressants are now the third most commonly prescribed drug class in this country with over 17 million Americans being prescribed antidepressant drugs in 2011.
When taken by pregnant women, antidepressants can cross the placenta and enter the fetal bloodstream. Exposure to a SSRI or SNRI is especially harmful during the first trimester because fetal heart development occurs early in pregnancy. The most critical period in cardiac development is between three and seven weeks after fertilization, when a heart tube assumes the shape of a four-chambered heart.
The most common forms of birth defects linked to SSRIs are atrial septal defects (ASD) and ventricular septal defects (VSD). An atrial septal defect, or ASD, is a hole between the upper chambers of the heart called the atria which allows blood to flow between the chambers. The defect allows oxygen-rich blood to flow directly from the left side of the heart to the right side of the heart, where it mixes with the oxygen-poor blood, or vice versa. A ventricular septal defect, or VSD, is a hole between the left and right ventricles of the heart. A ventricular septal defect is usually symptomless at birth and does not manifest itself until a child is a few weeks old.
Data released by the National Birth Defects Prevention Study of Infants indicates that a there is also a link between the use of SSRIs, such as Prozac, and an increased risk of the abdominal birth defects, including omphalocele (a birth defect where the infant’s intestine or other abdominal organs are covered only by a thin layer of tissue and can be easily seen or stick out of the belly button) and craniosynostosis (a birth defect that causes one or more sutures on a baby’s head to close earlier than normal – resulting in an abnormally shaped head).
Anti-depressants have also been linked to other serious congenital birth defects including:
• Anal atresia
• Bicuspid aortic valve
• Chiari malformation
• Cleft lip/palate
• Club foot
• Coarctation of the aorta
• Double aortic arch
• Double inlet left ventricle
• Double outlet right ventricle
• Hypoplastic left heart syndrome
• Pulmonary atresia
• Spina bifida
• Tethered spinal cord
• Tetralogy of the Fallot
• Transposition of the great vessels
• Tricuspic atresia
• Truncus arteriosus
There is a growing body of epidemiological evidence that anti-depressants can cause birth defects.
A study published in the British Medical Journal (BMJ) in 2005 found that children that were exposed to SSRIs during the first trimester were at a 60% higher probability of developing congenital heart defects compared to children that were not exposed to a SSRI.
A study published in the New England Journal of Medicine (NEJM) in 2006 found an increased risk of persistent pulmonary hypertension of the newborn (PPHN) in babies whose mothers used SSRIs late in pregnancy.
Another study published in the NEJM in 2007 found that children born to mothers using a SSRI during pregnancy were at a two-fold increased risk of having a heart defect than children whose mothers were not on a SSRI during pregnancy.
In January 2012, a study published in the BMJ found that third trimester use of a SSRI increased the risk of PPHN more than two-fold.
In a recent special on 60 Minutes, anti-depressants drugs were found to be no more effective than a placebo (sugar pill) for the vast majority of people using them, especially for individuals with mild to moderate depression.
SSRI Litigation & Trial Update
Hundreds of lawsuits have been filed around the country in both state and federal courts against the manufacturers of SSRIs and other anti-depressant medications.
In April 2012, all Zoloft cases involving birth defects filed in federal courts across the country were centralized in In Re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation, MDL No. 2342 before the Honorable Cynthia Rufe in the United States District Court for the Eastern District of Pennsylvania. As of April 2015, there were approximately 550 Zoloft cases docketed in the MDL. Judge Rufe has ordered the first bellwether trials will take place in the MDL in November and December 2015 respectively.
Later, in August 2013, all Effexor cases involving birth defects were also centralized before Judge Rufe in In Re: Effexor (Venlafaxine Hydrochloride) Products Liability Litigation, MDL No. 2458. There are currently 50 cases docketed in the Effexor MDL.
Over 200 Lexapro cases have been filed in Missouri state court and the first trials regarding Lexapro are scheduled to occur in Missouri and California state courts in spring of 2015. Additional Lexapro cases are pending in New Jersey.
In April 2015, a St. Louis, Missouri, jury returned a verdict in favor of Pfizer in the country’s first Zoloft case to go to trial. The next Zoloft trial is currently scheduled to occur later in 2015 in Pennsylvania state court in Philadelphia.
If you or a loved one used a SSRI while pregnant and gave birth to a child with a birth defect, you may be entitled to pursue a claim against the manufacturer of the SSRI for these injuries. For a free and confidential case evaluation, please call our office toll-free at (888) 747-5342 or complete our online contact form and we will promptly respond to your inquiry.