Prozac belongs to a group of antidepressant drugs called SSRIs, or selective serotonin reuptake inhibitors. These drugs function by increasing the level of serotonin in the brain, thereby relieving the symptoms of depression and improving certain mood disorders. Prozac (fluoxetine) was approved by the FDA in 1987 and has since been prescribed for the treatment of major depressive disorder, bulimia nervosa, obsessive-compulsive disorder and panic disorder. Prozac is currently manufactured by pharmaceutical company, Eli Lilly and Company, and has become one of the most popular antidepressant drugs available. In fact, as of 2007, Prozac was the third most frequently prescribed antidepressant on the market, after Zoloft and Lexapro, with 22.2 million prescriptions filled. Unfortunately, an emerging body of research has indicated that SSRI drugs like Prozac may no longer be considered an appropriate method of treatment for pregnant women suffering from depression or other mood disorders. According to these studies, women who take Prozac or other SSRIs may have a significantly increased risk of giving birth to infants with major birth defects, including limb defects like club foot.
Congenital limb defects occur when an upper or lower limb, or portion of a limb, fails to develop properly in utero, resulting in any number of malformations. Limb defects are typically immediately noticeable and are often diagnosed at birth. In some cases, limb defects may be associated with other life-altering bone conditions or syndromes. The most common types of limb defects are classified as:
Club foot is a type of limb defect in which a child is born with one or both feet smaller than normal and internally rotated at the ankle. In children with club foot, the tendons and ligaments of the affected limb are malformed, resulting in abnormalities in the size, shape and position of the foot or feet. Although club foot is typically a painless condition at birth, it can worsen over time and become a particularly debilitating condition later in life. Affected children may begin to walk on the outsides of their feet or ankles, causing large sores or callouses to form and restricting calf muscle growth.
The appropriate method of treatment for children with a limb defect depends largely upon the type and severity of the malformation. In some cases, the child may benefit from the use of orthotics, casts, splints, or a prosthetic limb, and may even require surgery followed by rehabilitation in order to restore the function of the child’s feet. The main goal of limb defect treatment is to correct the malformation and repair the appearance and function of the limb. In cases in which the defect cannot be completely repaired, the main goal may be to help the child adapt to and cope with the malformation.
In 2006, the FDA issued a public health advisory warning patients and healthcare professionals about the increased risk of persistent pulmonary hypertension of the newborn (PPHN) among infants exposed to SSRIs like Prozac during pregnancy. The FDA also required all sponsors of SSRI drugs to change prescribing information to include the potential risk of PPHN. PPHN is a severe heart and lung condition in which a child’s circulation continues to bypass the lungs after birth, preventing oxygen from reaching the rest of the body. These FDA warnings were issued in response to a New England Journal of Medicine study published in 2006 in which researchers found a six-times increased risk of PPHN among infants who were exposed to an SSRI like Prozac during pregnancy, compared to unexposed infants. According to the report, up to twelve out of 1,000 infants whose mothers took an SSRI after the twentieth week of pregnancy were born with PPHN, compared to the rate among the general population, which is one to two infants out of 1,000.
The following year, the NEJM published two additional studies in an attempt to determine what adverse side effects may be associated with fetal exposure to SSRI drugs like Prozac. According to the first study, infants born to women who took Prozac or another SSRI during the first trimester of pregnancy were nearly twice as likely to develop birth defects like limb defects, club foot and anal atresia. Researchers also found a possible connection between SSRIs and cleft palate, neural tube birth defects and cleft lip. The second study indicated that women who took an SSRI while pregnant were more than twice as likely to give birth to infants with catastrophic birth defects like anencephaly, omphalocele and craniosynostosis. According to another study published in 2010 in the American Journal of Nursing, infants exposed to an SSRI like Prozac in utero were nearly twice as likely to be born with serious heart defects, namely atrial and ventricular septal defects.
Prozac has been classified by the FDA as a pregnancy category C medication, which means it has the potential to cause serious harm to a fetus when taken during pregnancy. The FDA has advised healthcare professionals to avoid prescribing Prozac to pregnant women unless the possible benefits of the treatment outweigh the potential risks to the fetus. If you are currently pregnant or planning to become pregnant, and you are taking Prozac, consult your physician to discuss alternative treatment options. Suddenly discontinuing use of a prescription medication may be dangerous, but with your doctor’s help, you may be able to find a safer way to treat your condition.
All children deserve to live a long, healthy life. Unfortunately, for children born with a birth defect, their life may be cut short, or plagued with serious complications requiring long-term medical care. Although malformations like limb defects don’t often pose a life-threatening danger to affected children, it can make life more difficult. Furthermore, the necessary treatment for many birth defects often results in exorbitant medical bills, which can present an overwhelming financial burden for many families. If you or a loved one has suffered from a limb defect and you believe Prozac to be the cause, contact a qualified Prozac attorney to discuss your legal options. You may have grounds to file a Prozac lawsuit or Prozac class action lawsuit against Eli Lilly and Company in order to seek financial compensation for your injuries, medical expenses, and pain and suffering. Defective drug lawsuits also bring public attention to the importance of safe medications and the need for more stringent regulations on the dangerous drugs already on the market. Filing a Prozac lawsuit can be a complex process, but with the help of an experienced Prozac lawyer, you can feel confident that your case is in good hands.