Prozac Linked to Serious Birth Defects
Prozac (fluoxetine) was one of the first of a new generation of antidepressant drugs called SSRIs (select seritonin reuptake inhibitors). These drugs work by preventing the reabsorption of the neurotransmitter seritonin. Prozac and other SSRIs can cross the placental barrier in women who are pregnant and there is evidence linking the drugs to serious birth defects.
FDA Approval and Warnings
Prozac was developed by Eli Lilly and Company and received FDA approval in 1987 for the treatment of major depressive disorder and anxiety disorders. The FDA has classified the drug as a Category C for pregnancy which means it may cause fetal injury, but there is insufficient clinical data to prove the link between Prozac and birth defects. Several other SSRIs have been classified as Category D drugs which indicates there is clinical evidence linking them to birth defects.
In response to the results of a study published in the New England Journal of Medicine in June, 2006, the FDA issued a Prozac drug alert for medical professionals. The drug alert noted that the study found a six fold increase in the incidence of persistent pulmonary hypertension of the newborn (PPHN) in infants whose mothers took SSRIs after the 20th week of pregnancy. PPHN is a life threatening condition in which the ductus arteriosus, which diverts blood away from the lungs during gestation, fails to close at birth leading to respiratory distress.
Studies on Prozac Birth Defects
Although no studies have been done specifically on Prozac birth defects, two clinical studies, one published in the New England Journal of Medicine in June 2007 and the other published by the BMJ Group (formerly the British Medical Journal) in 2009, found an increased risk of septal heart defects in the infants of women who took SSRIs during the month before conception and/or the first three months of pregnancy.
While some studies have published contradictory results regarding birth defects other than septal heart defects, there is some evidence to support an increased risk of neural tube defects, abdominal defects and craniofacial defects in infants who were exposed to SSRIs during the first three months of gestation. Neural tube defects include anencephaly (fatal), craniosyntosis, macrocephaly and spina bifida. Abdominal defects include gastroschisis and omphalocele, and craniofacial defects include cleft palate and cleft lip.
Child developmental studies in Canada and Denmark have found that children of women who took SSRIs during pregnancy may be developmentally delayed. One of the factors that caused concern in the Danish study was that the children exhibited the developmental delays when compared to their peers at age 3 and age 6. This means that the children do not “catch up” to the peers over time.
Both the Canadian and Danish studies also noted an increase in the incidence of autism spectral disorders in children who were exposed to SSRIs during gestation.
A recent study in Finland confirmed that infants born to women who use SSRIs during pregnancy have an increased risk for septal heart defects. There was also an indication of a connection between SSRIs and neural tube defects. The Finnish researchers did not attribute all of the increased risks to SSRIs stating that the women in their study who took SSRIs were more likely to have additional risk factors like maternal age, alcohol and tobacco use.
Prozac Birth Defect Lawsuits
A large number of lawsuits for Prozac birth defects have been filed and more are being filed every day. The allegations against Eli Lilly and Company include failure to provide adequate warning of the danger of taking Prozac while pregnant and manufacturing and marketing a defective drug.
These product liability lawsuits ask for both compensatory and punitive damages. Compensatory damages include past and future medical expenses, lost wages, permanent disability and pain and suffering. Punitive damages are intended to punish wrong doing by a defendant and may exceed the amount of compensatory damages.
The exact number of Prozac lawsuits pending in state and federal district courts is unknown, but more than 250 lawsuits involving birth defects attributed to another SSRI, Zoloft, have been consolidated into a multidistrict litigation (MDL) in the Federal District Court for the Eastern District of Pennsylvania. The first cases in the MDL are scheduled for trial in September 2014 and the outcomes of these trials are likely to have an impact on birth defect lawsuits against the makers of other SSRIs including Prozac.
Free Compensation Evaluation
If you took Prozac during pregnancy and had a child with a Prozac birth defect, you may be eligible for compensation for medical bills, lost income and past and future expenses arising from your child’s care. You can get a free compensation evaluation by completing our short questionnaire. Our professionally trained staff is available to answer your questions and help you find a Prozac birth defects lawyer to handle your lawsuit.