Prozac belongs to a class of prescription antidepressant drugs called selective serotonin reuptake inhibitors, or SSRIs. These drugs were originally developed as a first line of defense against depression, although many SSRIs have been indicated for additional purposes, and some are even prescribed for off-label uses when physicians deem the treatment effective and safe. Prozac, for example, was approved by the FDA in 1987 and has since been approved for the treatment of major depressive disorder, panic disorder, bulimia nervosa and obsessive-compulsive disorder. Prozac (fluoxetine) functions by restoring the balance of serotonin in the brain, a neurotransmitter responsible for affecting mood. By doing so, Prozac and other SSRIs can effectively relieve depression and improve other mood disorders.
Prozac is currently manufactured by pharmaceutical company, Eli Lilly and Company, and has become one of the most popular antidepressants available. In fact, as of 2007, Prozac was the third most commonly prescribed antidepressant on the market, behind Zoloft and Lexapro, with over 22 million prescriptions filled. Unfortunately, Prozac and other SSRIs have become the subject of significant scrutiny in recent years, as extensive research has indicated that these drugs may not be safe, especially in the treatment of pregnant women. According to a number of SSRI side effect studies, Women who take Prozac while pregnant may significantly increase their risk of giving birth to infants with major birth defects, including neural tube birth defects.
Neural tube birth defects are congenital malformations caused by the failure of the neural tube to form properly when the child is in utero. The neural tube is the precursor to the child’s central nervous system, which is comprised of the brain and spinal cord. During normal fetal development, the neural tube is fully fused by the end of the first four weeks of pregnancy. When there is a complication during this process, a neural tube defect may occur, characterized by a malformation of the vertebrae protecting the spinal cord or the skull protecting the brain.
Neural tube birth defects are particularly dangerous because they are often accompanied by defects of the spinal cord and brain, which can cause difficulties in movement, learning and development. Common symptoms of neural tube birth defects include incontinence, lack of concentration and coordination, stiff joints, paralysis, muscle weakness, and difficulty reading and solving problems. Unfortunately, because neural tube defects are often accompanied by a number of serious complications, affected children typically require treatment from a team of experts whose main goal is to manage the child’s symptoms and encourage normal development in the future.
Anencephaly is one of the most severe forms of neural tube birth defect, characterized by the absence of large part of the brain and skull. This malformation occurs when the upper part of the neural tube fails to close completely during the early stages of fetal development. Children with this birth defect are typically born without a forebrain, the largest portion of the brain, or a cerebrum, which is responsible for movement, thinking and senses. Because of this malformation, affected infants are often born blind, deaf, unconscious and unable to feel pain. Children born with anencephaly may display reflex actions upon birth, like breathing, and response to sound and touch, but lack of a functioning cerebrum makes it impossible for the child to ever regain consciousness. Anencephaly is often accompanied by additional complications like facial feature abnormalities, absence of the skull, cleft palate and heart defects. There is currently no cure for anencephaly, and children born with this birth defect typically only survive for a few hours or days after birth.
In 2007, the New England Journal of Medicine published two SSRI side effect studies in which researchers examined the potential adverse effects of fetal exposure to SSRI antidepressants like Prozac. According to the first study, infants born to women who took an SSRI during the first trimester of pregnancy were nearly twice as likely to develop birth defects like club foot, limb defects, and anal atresia. Researchers also found a potential connection between SSRIs and neural tube birth defects, cleft palate and cleft lip. In the second study, researchers indicated that women who took an SSRI like Prozac while pregnant were more than twice as likely to give birth to infants with devastating birth defects like craniosynostosis, anencephaly and omphalocele.
Previously, the NEJM published an even more revealing study (2006) in which researchers determined that infants exposed to an SSRI like Prozac in utero were an alarming six times more likely to develop persistent pulmonary hypertension of the newborn (PPHN), a life-threatening heart and lung condition. According to the report, up to twelve out of 1,000 infants exposed to an SSRI after the twentieth week of pregnancy were born with PPHN, compared to the expected rate among the general population, which is one to two infants out of 1,000. Shortly after this study was released, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of PPHN among infants exposed to an SSRI during pregnancy. The FDA also required all SSRI sponsors to change prescribing information to include the potential risk of PPHN.
The FDA has labeled Prozac a pregnancy category C medication, which means it has the potential to cause serious complications for an affected child when taken during pregnancy. The FDA has also advised physicians to avoid prescribing Prozac to pregnant women unless the possible benefits of the treatment outweigh the potential risk to the fetus. If you are currently taking Prozac and you are pregnant or planning to become pregnant, consult your healthcare provider immediately. You should never suddenly stop taking a prescription medication, as this may cause further harm to you or your child. However, with your doctor’s help, you may be able to find a safer way to treat your condition.
Neural tube birth defects represent some of the most dangerous congenital malformations potentially linked to SSRI antidepressants like Prozac. Anencephaly, in particular, has the potential to rob a child of his right to live a long, healthy life. If you or a loved one has suffered from a neural tube birth defect, which you believe to be associated with Prozac, 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, in order to seek financial compensation for your injuries, medical expenses, and pain and suffering. By filing a Prozac lawsuit, you can also bring much-needed attention to the potentially harmful nature of the prescription drug, possibly preventing further injury in the future.
Consumers expect their prescription medications to effectively treat their condition without causing them any unnecessary harm. However, there are some drugs currently on the market for which the possible benefits are actually outweighed by the potential risks associated with the medication. It is only with accurate information about the advantages and disadvantages of drug treatments that consumers can make educated decisions about which drugs are safe to take and which are not. Unfortunately, some pharmaceutical companies intentionally withhold dangerous drug information from the FDA and from the public in an attempt to make their product more appealing to consumers. This deceptive practice leaves millions of consumers unknowingly vulnerable to serious injury and even death, which may have been avoided had the drug company taken the appropriate steps to prevent unnecessary harm. You are not at fault for injuries potentially caused by a prescription drug; call a Prozac lawyer to represent your case and collect the compensation you deserve.