Prozac, marketed by Eli Lilly and Company, is one of a group of prescription antidepressant medications called SSRIs, or selective serotonin reuptake inhibitors. These drugs work by increasing the level of serotonin in the brain, a neurotransmitter responsible for affecting mood. By doing so, Prozac and other SSRIs can effectively relieve the symptoms of depression and improve certain mood disorders. The active ingredient in Prozac is fluoxetine, and the drug was approved by the FDA in 1987. Since its inception, Prozac has been approved for the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, and bulimia nervosa.
Eli Lilly went to great lengths to market Prozac as the first SSRI antidepressant; although three other SSRIs were introduced before Prozac, two were removed from the market due to serious adverse side effects. Prozac and other SSRI drugs have become increasingly popular in recent years despite research which suggests that these medications may cause serious side effects when taken by pregnant women. According to a number of studies, women who take SSRIs like Prozac during pregnancy may significantly increase their risk of giving birth to infants with one or more major birth defects, including PPHN.
Persistent pulmonary hypertension of the newborn, or PPHN, is a serious birth defect in which a child’s circulation continues to bypass the lungs after birth, depriving the body of oxygen. When a child is in the womb, use of the lungs isn’t yet necessary because the placenta provides the baby with the oxygen it needs through the umbilical cord. After the child is born, the body adapts to breathing outside the womb and the lungs become involved in the exchange of oxygen and carbon dioxide. In children born with PPHN however, the flow of blood continues to bypass the lungs. The child can breathe, but the oxygen in the breathed air will not reach the bloodstream to be delivered to the rest of the body.
Common symptoms of PPHN include rapid heart rate, rapid breathing, cyanosis (bluish tint to the skin), low oxygen levels, and respiratory distress. In some cases, the affected child may exhibit a heart murmur. Children whose bodies continue to supply an insufficient amount of oxygen to their organs have a significant risk of suffering mass organ damage and even death. Common treatments for infants suffering from PPHN include delivery of 100% supplemental oxygen, assisted ventilation, nitric oxide treatment, high frequency oscillatory ventilation, and Extracorporeal Membrane Oxygenation (ECMO). With prompt diagnosis and aggressive treatment, some cases of PPHN can be reversed. Unfortunately, even with treatment, some children may continue to deliver inadequate amounts of oxygen to the rest of the body. This lack of oxygen may result in life-threatening side effects like shock, seizures, heart failure, kidney failure, brain hemorrhages, and even death.
In 2006, the FDA issued a public health advisory warning patients and healthcare professionals about the increased risk of PPHN among infants exposed to SSRIs like Prozac during pregnancy. This notice came on the heels of a New England Journal of Medicine study published earlier that year in which researchers found an alarming six-times increased risk of PPHN among infants whose mothers took an SSRI after the twentieth week of pregnancy, compared to infants whose mothers received no antidepressant treatment. According to researchers, up to twelve out of 1,000 infants exposed to an SSRI developed PPHN, compared to the expected rate among the general population, which is one to two infants out of 1,000.
In 2007, the NEJM published two additional studies in which researchers examined the potential adverse side effects associated with fetal exposure to Prozac. According to the first study, women who took an SSRI like Prozac during the first trimester of pregnancy were nearly twice as likely to give birth to infants with birth defects like club foot, limb defects and anal atresia. Researchers also found a possible link between SSRIs and cleft lip, cleft palate and neural tube birth defects. The second study indicated that infants whose mothers took an SSRI like Prozac while pregnant were more than twice as likely to be born with catastrophic birth defects like anencephaly, craniosynostosis and omphalocele.
Prozac has been classified by the FDA as a pregnancy category C medication, which means it may cause serious harm to a fetus when taken during pregnancy. Due to this potential for causing adverse side effects, the FDA has advised physicians 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 taking Prozac and you are pregnant or planning to become pregnant, consult your healthcare provider to discuss alternative treatment options. It may be dangerous to suddenly discontinue use of a prescription medication, but your doctor may be able to suggest a safer way to treat your condition.
All children deserve to live a healthy and happy life. Unfortunately, being born with a birth defect can prevent children from realizing this right, potentially forcing them to suffer from serious complications and sometimes requiring long-term medical treatment. If you or a loved one has suffered from a birth defect like PPHN and you believe Prozac to be the cause, contact a Prozac attorney to discuss your legal options. You may have grounds to file a Prozac lawsuit or Prozac class action lawsuit in order to seek financial compensation for your injuries and medical expenses.
Victims of serious injury resulting from the use of a dangerous drug are not at fault. Unfortunately, some drug companies intentionally withhold the more serious side effects of their medications in an attempt to make their product more appealing to the public. This deceptive practice exposes millions of consumers to serious injury and even death, without their knowledge. The only way to protect yourself from further harm following a birth defect diagnosis is to hire a Prozac lawyer to represent your case.