Prozac lawsuits may be filed by attorneys across the US for possibly leading to birth defetcs such as PPHN, heart defects, and neural tube malformations when used in pregnancy.
Depression and other mood disorders can have serious consequences on an affected individual’s life. Major depressive disorder is characterized by decreased mood, concentration and energy, as well as changes in appetite, thoughts, and behavior. Depression can also interfere with personal relationships, social interactions, sleeping and eating habits, and productivity at school or work. In order to relieve the symptoms of depression and other conditions, like obsessive-compulsive disorder and panic disorder, many individuals are prescribed SSRI antidepressants like Prozac.
Since the introduction of the first SSRI more than twenty years ago, these antidepressants have become known as the first line of defense against depression. In fact, according to the U.S. Centers for Disease Control and Prevention, antidepressants have become the most commonly prescribed drug in the United States, with 118 million prescriptions filled in 2005. Unfortunately, recent side effect research has indicated a potential connection between the use of SSRIs like Prozac and the development of major birth defects in infants exposed to the drugs in utero. Among these birth defects are:
What is Prozac?
Prozac is a prescription antidepressant medication which falls into the category of SSRIs, or selective serotonin reuptake inhibitors. These drugs function by restoring balance to the level of serotonin in the brain, thereby relieving depression and improving certain mood disorders. The active ingredient in Prozac is fluoxetine, and the drug has been approved by the FDA for the treatment of major depressive disorder, panic disorder, bulimia nervosa, and obsessive-compulsive disorder. Prozac was approved by the FDA in 1987 and was marketed by manufacturing company, Eli Lilly and Company, as the first SSRI drug. Although three other SSRIs preceded Prozac, two were withdrawn due to adverse side effects, and Eli Lilly went to great lengths to ensure that Prozac was perceived by the public as a scientific breakthrough. Despite the fact that several new SSRI antidepressant medications have been introduced since Prozac, Eli Lilly’s drug remains extremely popular. In 2007, twenty years after its introduction to the U.S. market, fluoxetine held the spot of third most prescribed SSRI antidepressant after Zoloft and Lexapro, with 22.2 million prescriptions filled.
Prozac and Birth Defects
“Despite the fact that the allegedly harmful nature of Prozac has been apparent for several years, the drug remains on the market…”
According to a study published in 1996 in the British Medical Journal, infants born to women who take the antidepressant medication, Prozac, during the third trimester of pregnancy may have an increased risk of developing minor birth defects. Researchers from the University of California indicated that three or more minor abnormalities occurred in 15.5% of infants exposed to Prozac in utero, a percentage more than twice that of the control group of infants, which was 6.5%.
In 2006, the New England Journal of Medicine published a study which indicated that infants whose mothers took an SSRI antidepressant like Prozac after the twentieth week of pregnancy were six times more likely to develop PPHN, a potentially fatal heart and lung condition. According to researchers, up to twelve out of 1,000 infants exposed to an SSRI in utero were born with PPHN, compared to the average among the general population, which was one to two out of 1,000.
The NEJM published two additional studies in 2007 which sought to determine the nature and extent of adverse Prozac side effects potentially associated with SSRI use. One study suggested that infants born to women who took an SSRI while pregnant were more than twice as likely to be born with birth defects like craniosynostosis and omphalocele, compared to infants whose mothers didn’t take an SSRI during pregnancy. In the second study, researchers indicated that infants who were exposed to SSRI antidepressants during the first trimester of pregnancy were nearly two times as likely to give birth to children with birth defects like anal atresia, neural tube birth defects, and limb defects, than unexposed infants.
More recently, in 2010, a study published in the American Journal of Nursing suggested that SSRI use during the first trimester of pregnancy may significantly increase an infant’s risk of suffering from heart defects, namely atrial septal defects and ventricular septal defects. According to researchers, the prevalence of septal heart defects among infants exposed to SSRIs like Prozac was 0.9%, compared to the prevalence among unexposed infants, which was 0.5%. The risk of heart defects was even higher among infants whose mothers took more than one SSRI during pregnancy.
Prozac FDA Warnings
Shortly after the NEJM released their 2006 study, the FDA issued a public health advisory regarding the potential connection between the use of SSRIs like Prozac and the development of PPHN. The FDA also required all sponsors of SSRIs to update their drugs’ warning labels to include potential pregnancy precautions, particularly the risk of PPHN. Despite the fact that the allegedly harmful nature of Prozac has been apparent for several years, the drug remains on the market, prescribed to millions of consumers, including pregnant women, each year.
Prozac Use While Pregnant
The FDA has classified Prozac as a pregnancy category C medication, which means it may cause harm to a human fetus if taken during pregnancy. Unfortunately, the Journal of the American Medical Association has estimated that at least 80,000 pregnant women in the United States are prescribed SSRI antidepressants like Prozac in any given year. If you are currently taking Prozac and you are pregnant or planning to become pregnant, consult your physician as soon as possible. It is never encouraged to discontinue use of a prescription medication without medical consent, but the FDA has advised healthcare providers to avoid prescribing Prozac to pregnant women unless the possible benefits of Prozac treatment justify the potential risks to the fetus.
A Prozac Attorney Can Help
Victims of serious injuries potentially associated with the use of a defective drug are not at fault and may be entitled to reimbursement for their injuries, the medical expenses resulting from injury treatment, and the pain and suffering endured by victims and their families. If you or a loved one has suffered from a birth defect which you believe to be linked to the use of Prozac, contact a Prozac attorney for legal guidance, as you may have grounds to file a Prozac lawsuit against pharmaceutical company, Eli Lilly. Drug manufacturing companies are responsible for the safety of their medications and should be held accountable for adverse side effects sustained by consumers of their products. The only way to protect your rights and stand up to big drug companies is to hire an experienced Prozac lawyer to represent your case.