Prozac belongs to a class of antidepressant medications called selective serotonin reuptake inhibitors, or SSRIs. These drugs work by restoring balance to the level of serotonin in the brain, a neurotransmitter responsible for controlling mood. By doing so, Prozac and other SSRIs can effectively relieve the symptoms of depression and improve certain mood disorders. Prozac has been on the market since it garnered FDA approval in 1987, and is frequently prescribed to individuals suffering from conditions like major depressive disorder, panic disorder, obsessive-compulsive disorder and bulimia nervosa. Prozac (fluoxetine) is manufactured by pharmaceutical company, Eli Lilly and Company, and has become one of the most commonly prescribed antidepressants on the U.S. market.
Regardless of the popularity of Prozac and other SSRIs, serious concerns have been raised about the safety of these medications, especially in treating pregnant women. In fact, a number of SSRI side effect studies have indicated that women who take SSRI antidepressants during pregnancy may significantly increase their risk of giving birth to infants with serious birth defects, including a malformation called anal atresia. Despite this potential for harm, the Journal of the American Medical Association estimates that more than 80,000 pregnant women are prescribed SSRI drugs like Prozac in the United States in any given year.
Anal atresia is a congenital birth defect in which a child is born with an opening to the anus that is absent or blocked. The anus is the opening to the rectum through which stools leave the body. Anal atresia, commonly called imperforate anus, can occur in several different forms. In some cases, the rectum ends in a blind pouch that doesn’t connect to the colon. In others, it may have openings to the bladder, urethra, vagina in girls or base of the penis in boys. Common symptoms of anal atresia are:
Anal atresia occurs due to the failure of a fetus to develop properly in utero, and the malformation is often accompanied by additional birth defects, which can cause further problems for an affected child.
Because children with anal atresia often suffer from other birth defects as well, all affected children should be tested for additional malformations, especially those of the spine, genitals and urinary tract. In order to repair anal atresia, surgical reconstruction of the anus is required. If the rectum connects with other organs, these organs may also need to be repaired. With treatment, most children make a full recovery from anal atresia. Unfortunately, some children may continue to struggle with serious complications, including constipation, incontinence and intestinal blockage.
In 2007, the New England Journal of Medicine published two studies in which researchers examined the potential adverse side effects of SSRI drugs like Prozac. According to the first study, infants born to women who took an SSRI antidepressant during the first trimester of pregnancy were nearly twice as likely to develop birth defects like anal atresia, limb defects and club foot. Researchers also found a potential connection between SSRIs and cleft palate, cleft lip and neural tube birth defects. The second study 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 anencephaly, craniosynostosis and omphalocele.
In 2006, the NEJM published a significant study in which researchers determined that fetal exposure to SSRIs like Prozac increased an infant’s risk of being born with PPHN by an alarming six times. PPHN, or persistent pulmonary hypertension of the newborn, is a dangerous birth defect in which a baby’s circulation continues to bypass the lungs, depriving the rest of the body of oxygen. According to researchers involved in this study, up to twelve out of 1,000 infants exposed to an SSRI after the twentieth week of pregnancy developed PPHN, compared to the expected rate among the general population, which is one to two infants out of 1,000.
Prozac has been classified as a pregnancy category C medication by the FDA, which means the drug may cause serious harm to a fetus when taken during pregnancy. After reviewing the results of the 2006 NEJM article, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of PPHN among infants exposed to Prozac and other SSRIs during pregnancy. The FDA also required all SSRI sponsors to change prescribing information to include the potential risk of PPHN. If you are currently taking Prozac and you are pregnant or planning to become pregnant, consult your physician immediately. You should never stop taking a prescription medication without medical consent, but with your doctor’s help, you may be able to find a safer alternative to Prozac for treating your medical condition.
Although birth defects like anal atresia can typically be treated effectively with surgery, the additional birth defects that often accompany anal atresia can cause life-altering complications for an affected child. In some cases, these birth defects may require extensive treatment followed by long-term medical care, which can amount to a significant financial burden for many families. If you or a loved one has suffered from anal atresia, which you believe to be associated with Prozac, contact a qualified Prozac attorney to discuss your legal options. You may be entitled to financial compensation for your injuries and medical expenses, which you can collect by filing a Prozac lawsuit or Prozac class action lawsuit against Eli Lilly.
Besides allowing you to collect the compensation you deserve, defective drug lawsuits also bring much-needed attention to the potentially harmful nature of some drugs, possibly preventing further dangerous drug-related injuries and death in the future. Filing a Prozac lawsuit can be a complicated process. Fortunately, Prozac lawyers are experienced in defective drug litigation and will work their hardest to ensure you receive a fair settlement or damages for your injuries and pain and suffering. Following a birth defect diagnosis, the families of victims should be given adequate time to concentrate on seeking proper medical care for their child, without having to worry about filing a defective drug lawsuit as well. With the help of a knowledgeable Prozac attorney, victims of alleged Prozac birth defects can feel confident that their case is being effectively and professionally represented.