Prozac is one of a group of antidepressant drugs called SSRIs, or selective serotonin reuptake inhibitors, which function by restoring the balance of serotonin in the brain, a neurotransmitter responsible for controlling mood. Prozac (fluoxetine) was approved by the FDA in 1987 and is indicated for the treatment of major depressive disorder, bulimia nervosa, obsessive-compulsive disorder, and panic disorder. Eli Lilly and Company is the pharmaceutical company responsible for manufacturing Prozac, a drug the company marketed as the first SSRI antidepressant. Three other SSRI drugs were actually developed before Prozac, but two were withdrawn due to serious adverse side effects, and Eli Lilly made sure the public perceived Prozac as a groundbreaking discovery.
Despite the popularity of Prozac in treating depression and other disorders, the antidepressant drug may be associated with the development of serious side effects, namely birth defects among infants. According to a number of side effect studies, women who take antidepressants like Prozac may significantly increase their risk of giving birth to infants with one or more major birth defects, including:
Because of these potential Prozac birth defects, the FDA has advised patients to consider all benefits and risks involved in taking Prozac during pregnancy before making any decisions to continue or discontinue use of the drug.
Perhaps the most revealing SSRI antidepressant birth defect study was published in the New England Journal of Medicine in 2006, in which researchers found a six-times increased risk of PPHN among infants exposed to an SSRI like Prozac during the third trimester of pregnancy. PPHN, or persistent pulmonary hypertension of the newborn, is a life-threatening condition in which a child’s circulation continues to bypass the lungs after birth, preventing the body’s organs and tissues from receiving the oxygen they require. According to the study, up to twelve out of 1,000 infants whose mothers took an SSRI after the twentieth week of pregnancy developed PPHN, compared to the rate among the general population, which is one to two infants out of 1,000. After reviewing these results, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of PPHN among infants exposed to an SSRI like Prozac in utero.
The following year, the NEJM published two additional Prozac side effect studies, the first of which indicated that infants born to women who took an SSRI during the first trimester of pregnancy were nearly twice as likely to be born with birth defects like limb defects, club foot and anal atresia. Researchers also found a potential connection between SSRIs and cleft palate, neural tube birth defects and cleft lip. In the second study, infants whose mothers took an SSRI like Prozac while pregnant were more than twice as likely to develop devastating birth defects like anencephaly, omphalocele and craniosynostosis. According to a 2010 study published 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, particularly atrial and ventricular septal defects.
The FDA has classified Prozac 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 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 healthcare provider immediately. You should never suddenly stop taking a prescription medication, as this may cause further harm to you or your child, but with your doctor’s help you may be able to find a safer way to treat your condition.
Despite this potential for causing serious adverse side effects, the Journal of the American Medical Association estimates that more than 80,000 pregnant women are prescribed SSRI antidepressants like Prozac in the United States in any given year. If you or a loved one has suffered from a serious birth defect and you believe Prozac to be the cause, contact a Prozac attorney to discuss the benefits of filing a Prozac lawsuit against Eli Lilly and Company. The main goal of Prozac lawsuits and potential Prozac class action lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering endured by you and your family.
Drug companies are responsible for producing and marketing safe medications, and are also expected to alert the public of any hazards associated with their products. Unfortunately, some pharmaceutical companies intentionally conceal this information in an attempt to protect themselves from negative consequences, such as a drug recall. This deceptive practice exposes millions of consumers to irreversible injury and even death, which could have been avoided had the drug company taken the appropriate steps to prevent unnecessary harm. With the help of a qualified Prozac lawyer, victims of alleged Prozac birth defects can protect their rights and collect the compensation they deserve.