Lexapro Linked to Serious Birth Defects
Lexapro (escitalopram oxalate) is a select seritonin reuptake inhibitor (SSRI) used to treat clinical depression and anxiety disorders. Recent clinical studies have linked the use of SSRIs during pregnancy to an increased risk of serious birth defects. Birth defects associated with fetal exposure to SSRIs include neural tube defects, septal heart defects, craniofacial defects and PPHN (persistent pulmonary hypertension of the newborn).
FDA Approval and Warnings
Lexapro received FDA approval for the treatment of major depressive disorder and anxiety disorders in August of 2002 and was released to the market by Forest Laboratories in September. Hailed for its efficacy in lower doses than older SSRIS and its low incidence of side effects and drug interactions, Lexapro was a welcome new treatment option for many doctors and their patients.
In July of 2007, the FDA issued an alert to health care professionals warning that women taking SSRIs, like Lexapro, after the 20th week of pregnancy, were 6 times more likely to give birth to an infant with PPHN than women who did not take antidepressants. The alert came after publication of a study in the New England Journal of Medicine that clearly indicated that SSRIs presented a significantly increased risk for this specific birth defect.
A number of studies of women who took SSRIs in the first trimester of pregnancy have linked SSRIs to birth defects including neural tube defects, septal heart defects, craniofacial defects and abdominal defects. Researchers believe the increased risk of birth defects from these drugs may be related to their action on seritonin, a neurotransmitter that plays a crucial role as an embryo develops into a fetus. There is also a significant increase in the incidence of miscarriages among women taking SSRIs.
The FDA has classified Lexapro as a Category C drug which means that animal studies indicate the risk of fetal injury, but there is no clinical evidence that the drug causes Lexapro birth defects in humans. This classification is ambiguous since in many instances no trials have been performed on pregnant women and in the absence of research studies of a particular drug, there is no definitive clinical evidence that the drug causes birth defects.
Recent Studies of SSRIs and Birth Defects
A recent Finnish study on use of SSRIs during pregnancy found no increased risk of stillbirth or neonatal mortality in children of women using SSRIs and a small increase in the incidence of postneonatal mortality which they associated with the psychiatric disease in the mother. They noted that women taking SSRIs were more likely to present other risk factors for pregnancy including maternal age and tobacco use. They did find an increase in septal heart defects among women whose SSRI contained fluoxetine or paroxetine.
The Finnish study contradicts earlier studies that have shown a significant increase of risk for certain specific birth defects if SSRIs were taken during the first 12 weeks of pregnancy. Serious congenital conditions associated with SSRI exposure in utero include neural tube defects (anencephaly, craniosyntosis), septal heart defects and abdominal defects (gastroschisis).
There have been no studies specifically targeted for Lexapro birth defects.
Forest Laboratories Settles with Federal Government
In a 2009 crack down on illegal marketing practices by pharmaceutical companies, the U.S. Department of Justice accused Forest Laboratories of paying kickbacks to doctors who prescribed Lexapro, failing to disclose negative results from clinical trials of the drug and marketing Lexapro for unapproved (off label) uses. The drug maker agreed to pay $313 million dollars in fines and penalties in 2010 for charges related to Lexapro and two other drugs. Sales of Lexapro topped $355 million in 2007.
Lexapro Birth Defects Lawsuits
Three Lexapro lawsuits were filed in the St. Louis County Circuit Court in Missouri in February of 2012. The plaintiffs in the lawsuits allege that when they took Lexapro during their pregnancies they were unaware of the risks to their unborn infants. The congenital defects suffered by the children of the women include spina bifida, club foot and cleft palate which are all birth defects associated with exposure to SSRIs during early gestation.
These three plaintiffs join a growing group of parents who are bringing legal action for Lexapro birth defects to their children. Allegations against defendant Forest Laboratories include accusations that the company withheld negative results from clinical trials and failed to provide adequate warning of the dangers of taking Lexapro while pregnant. There are unconfirmed reports that Forest Laboratories has begun settlement negotiations with individual plaintiffs.
Free Compensation Evaluation
If your child suffered birth defects related to your use of Lexapro during pregnancy, you may be entitled to legal compensation for medical bills, lost wages and other related past and future expenses. To get a free compensation evaluation of your case, simply complete our brief questionnaire. Our trained staff is available to answer your questions and to help you find a Lexapro lawyer to handle your legal action.