Paxil belongs to a class of prescription antidepressant medications called SSRIs, or selective serotonin reuptake inhibitors. These drugs function by restoring the balance of serotonin in the brain, a neurotransmitter responsible for controlling mood. By doing so, these drugs can effectively relieve depression and improve other mood disorders. Paxil was originally approved by the FDA in 1992 to treat individuals with major depressive disorder. In 1996, the FDA approved an indication for obsessive-compulsive disorder and major panic disorder, in 1999 for social anxiety disorder, in 2000 for post-traumatic stress disorder, and in 2001 for generalized anxiety disorder. The active ingredient in Paxil is paroxetine, and the drug is currently manufactured by pharmaceutical company, GlaxoSmithKline.
Despite the fact that Paxil and other SSRI antidepressants have become some of the most widely prescribed prescription medications on the market, the results of recent birth defect studies may raise concerns about the safety of these drugs, especially in treating pregnant women. According to research, women who take SSRI antidepressants like Paxil while pregnant may significantly increase their risk of giving birth to infants with one or more major birth defects, including PPHN.
PPHN, or persistent pulmonary hypertension of the newborn, is a serious birth defect in which a child’s circulation continues to bypass the lungs after birth. When the child is in the womb, the lungs aren’t necessary in the exchange of oxygen because the placenta provides the baby with oxygen through the umbilical cord. Once the child is born, the body adapts to breathing outside the womb and blood returning to the heart from the body can be pumped into the lungs, where oxygen and carbon dioxide are exchanged. However, in children with PPHN, the circulatory system fails to make this change and blood flow continues to bypass the lungs. Even though the child can breathe, oxygen in the breathed air will not reach the bloodstream, and the child’s vital organs and tissues will not receive the oxygen they require.
Because PPHN deprives the body of its essential oxygen supply, the resulting symptoms are:
In some cases, children with PPHN may also exhibit a heart murmur, which is an extra or abnormal heart sound. The affected child may also continue to have low oxygen levels in the blood even while receiving extra oxygen to breathe.
The main goal of PPHN treatment is to maximize the amount of oxygen being delivered to the infant’s lungs. In order to do so, the child may receive 100% supplemental oxygen, assisted ventilation, nitric oxide treatment to improve blood flow, high frequency oscillatory ventilation, and Extracorporeal Membrane Oxygenation (ECMO) in instances of major heart and lung failure. Unfortunately, even with prompt diagnosis and treatment, some children may continue to deliver inadequate amounts of oxygen to the rest of the body. These children may suffer from shock, seizures, heart failure, mass organ damage, kidney failure, brain hemorrhage, and even death.
The potentially harmful nature of Paxil has been evident for several years. In 2005, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of congenital birth defects, namely heart defects, among infants exposed to paroxetine (Paxil) during pregnancy. The FDA notice came in response to information provided by two unpublished epidemiology studies, which also led to the elevation of Paxil’s pregnancy category from C to D. The first study used data from a Swedish national registry to evaluate the potentially harmful nature of in-utero Paxil exposure for infants. According to the report, women who took Paxil in early pregnancy had a nearly two-fold increased risk for giving birth to an infant with a heart defect, compared to the entire national registry population. The second study was conducted in the United States and determined that infants born to women who took Paxil during the first trimester of pregnancy had a 1.8-fold increased risk for congenital birth defects in general, and a 1.5-fold increased risk for heart defects, compared to infants exposed to other antidepressants in utero.
The FDA issued another public health advisory in 2006 in response to new information concerning the potential connection between the use of SSRI antidepressants during pregnancy and PPHN. This warning came on the heels of a New England Journal of Medicine study published earlier that year, in which researchers found a six-times increased risk of PPHN among infants exposed to SSRIs like Paxil after the twentieth week of pregnancy, compared to unexposed infants. The NEJM published two additional antidepressant birth defect studies in 2007. The first study indicated that infants whose mothers took an SSRI antidepressant 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 connection between these drugs and cleft lip, cleft palate and neural tube birth defects. According to the second study, women who took an SSRI like Paxil while pregnant were more than twice as likely to give birth to infants with catastrophic birth defects like anencephaly, craniosynostosis and omphalocele.
The FDA has elevated the pregnancy category of Paxil from C to D, which means there is positive human evidence illustrating the drug’s potential to cause serious harm to a fetus when taken during pregnancy. The FDA has advised physicians to avoid prescribing Paxil to pregnant women unless the possible benefits of the drug justify the potential risks to the fetus. If you are currently pregnant or planning to become pregnant, and you are taking Paxil, consult your physician to discuss alternative treatment options. It may be dangerous to suddenly discontinue use of a prescription medication without medical consent, but with your doctor’s help, you may be able to find a safer way to treat your condition.
SSRI antidepressants like Paxil may be associated with the development of major and even life-threatening birth defects among infants whose mothers take the drugs during pregnancy. Unfortunately, according to the Journal of the American Medical Association, over 80,000 pregnant women in the U.S. are prescribed SSRI antidepressants like Paxil in any given year. If you or a loved one has suffered from PPHN and you believe Paxil to be the cause, contact a Paxil attorney as soon as possible. You may be entitled to reimbursement for your injuries, medical expenses, and pain and suffering, which you can collect by filing a Paxil lawsuit against GlaxoSmithKline.
You are not at fault for any injuries caused by the proper use of a dangerous drug. Pharmaceutical companies like GlaxoSmithKline are responsible for producing safe and effective medications, and should be held liable for any adverse side effects sustained by consumers of their products. Unfortunately, some drug manufacturing companies deny liability for injuries allegedly caused by their medications in an attempt to avoid negative consequences like a drug recall. Others are actually aware of the harmful nature of their drugs and intentionally withhold this information in order to ensure their product is well-received by the public. These deceptive practices put millions of consumers at risk of suffering serious injury, illness and even death, which could have been prevented had the drug company taken the appropriate steps to avoid unnecessary harm. Only by hiring a qualified Paxil lawyer to represent their case can victims of alleged Paxil birth defects protect their rights and collect the compensation they deserve.