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Millions of Americans have been prescribed Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs). In fact, the American Medical Association reports that more than 40,000 pregnant women in the United States regularly take antidepressants. Unfortunately, the drug companies who sell antidepressants have done an inadequate job of educating doctors and mothers about the risks these drugs pose to a fetus. Consequently, thousands of babies have been born with congenital birth defects related to in utero exposure to antidepressants.
Kirkendall Dwyer LLP is currently accepting birth defect cases involving the following antidepressant drugs:
In December 2005, the FDA issued a Public Heath Advisory for Paxil, which is an SSRI and in the same drug class as Prozac, Zoloft, Celexa and Lexapro. (read advisory here)
The 2005 FDA warning was based on two scientific studies. One study relied on the Swedish national registry data; the authors concluded that women who took Paxil in early pregnancy had an approximately 2-fold increase risk of having an infant with a cardiac defect, compared to the entire national registry population.
Another study relied on an insurance database from the United States. Those authors determined that women who received Paxil in the first trimester had a 1.5-fold increased risk for cardiac malformations and a 1.8-fold increased risk for congenital malformations overall, compared to infants of women who received other antidepressants in the first trimester.
The most common cardiac defect observed in these studies were atrial septal defect and ventricular septal defect. These types of heart defects are located in the wall dividing the left and right side of the heart.
On December 8, 2005, the FDA asked GSK to change Paxil’s pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women have demonstrated a risk to the human fetus. (read details here)
Unfortunately, this warning was given to doctors more than 10 years after Paxil first came to market and after GSK spent hundreds of millions of dollars promoting Paxil without these serious warnings. Similarly, the updated label change for Paxil came after other SSRIs like Zoloft, Prozac, and Celexa had been on the market for extended periods of time.
In February 2006, the New England Journal of Medicine published an abstract based on a third antidepressant birth defect study entitled Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn (PPHN). (study results here) This abstract reported over a 6-fold increased risk of Persistent Pulmonary Hypertension of the Newborn in children exposed to SSRIs in utero.
On July 19, 2006, the FDA released another Public Health Advisory: Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns. ( read advisory here )
This Public Health Advisory was based on the abstract in the New England Journal of Medicine and covered the following antidepressants:
Unfortunately, these Public Health Advisories came more than a decade after the major pharmaceutical companies released these drugs and spent hundreds of millions of dollars promoting them to doctors and women. Consequently, thousands of children were born with cardiac defects and PPHN.
If you took an antidepressant and your child was born with one of the above-mentioned birth defects, your child may be entitled to financial compensation. Call a personal injury attorney at Kirkendall Dwyer LLP to discuss the details of your case and to see if you qualify. Your case review is free, and we do not get paid unless you do. You have nothing to lose, and only knowledge to gain.