Paxil belongs to a group 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, thereby relieving depression and improving certain mood disorders. The active ingredient in Paxil is paroxetine, and the drug originally garnered FDA approval in 1992 for the treatment of major depressive disorder. The FDA approved an additional indication in 1996 for major panic disorder and obsessive-compulsive disorder, in 1999 for social anxiety disorder, in 2000 for post-traumatic stress disorder, and in 2001 for generalized anxiety disorder. Paxil is currently manufactured by pharmaceutical company GlaxoSmithKline.
According to the FDA and a number of studies conducted in recent years, SSRI antidepressants like Paxil may not be safe in treating pregnant women. This body of research has indicated that infants whose mothers take SSRI antidepressants like Paxil during pregnancy may significantly increase their risk of developing major birth defects, particularly heart defects.
Heart defects are the result of malformations occurring during fetal development which affect the structure of the heart or the blood vessels surrounding the heart. Some heart defects obstruct the flow of blood in the heart, and others affect the walls of the heart or cause blood to flow through the heart in an abnormal pattern. While some heart defects are minor and may never be detected, more than half of all infants born with heart defects require treatment for their condition, typically surgery. Two of the most common heart defects are atrial septal defects and ventricular septal defects, both of which are characterized by a hole in the wall of the heart.
An atrial septal defect is a heart defect present at birth in which the wall separating the upper chambers of the heart (atria) fails to close completely in utero. This results in a hole which allows blood to flow between the left and right atria; an excessive amount of blood in the right side of the heart can cause pressure to build up in the lungs. Although small atrial septal defects often cause few problems and may not be detected until later in life, large defects can lead to a number of complications, including shortness of breath, poor appetite, fatigue and frequent lung infections. Children born with this malformation are also at an increased risk of developing heart failure, pulmonary hypertension and stroke.
Ventricular septal defects are one of the most common congenital heart defects. This type of malformation is characterized by a hole in the wall separating the right and left ventricle, which may allow blood to flow between the right and left sides of the heart. Not only can this cause the heart to work harder than normal, but it can also allow an excessive amount of blood to flow to the lungs, potentially causing pressure in the lungs to elevate to a dangerous level. Common symptoms of a ventricular septal defect are sweating, rapid heartbeat, rapid breathing, poor weight gain and decreased feeding. Without adequate treatment, an infant born with a ventricular septal defect may experience life-threatening complications like pulmonary hypertension, aortic regurgitation and endocarditis.
The FDA issued a public health advisory in 2005 alerting the public of its decision to elevate the pregnancy category of Paxil from C to D. The notice was also intended to warn patients and healthcare professionals about the possible link between the use of paroxetine (Paxil) during pregnancy and an increased risk of congenital birth defects, namely heart defects. This advisory was released in response to information provided by two unpublished epidemiology studies. The first study used data from a Swedish national pregnancy registry in order to evaluate the potentially hazardous nature of in-utero exposure to Paxil. According to the report, infants whose mothers took Paxil in early pregnancy were nearly twice as likely to be born with a heart defect, compared to the risk among the entire registry population. The second study indicated that infants born to women who took Paxil during the first trimester of pregnancy had a 1.5-fold increased risk of developing heart defects and a 1.8-fold increased risk of being born with birth defects in general, compared to infants exposed to other antidepressant drugs in utero.
In 2006, the FDA issued another public health advisory after new information was discovered in a New England Journal of Medicine study conducted that same year. According to the study, infants whose mothers took SSRI antidepressants like Paxil after the twentieth week of pregnancy were an alarming six times more likely to suffer from PPHN. PPHN, or persistent pulmonary hypertension of the newborn, is a life-threatening heart and lung condition in which an infant’s circulation continues to bypass the lungs after birth, depriving the body’s tissues and organs of oxygen.
In 2010, the American Journal of Nursing published a study in which researchers found that infants exposed to SSRI antidepressants like Paxil during pregnancy were nearly twice as likely to suffer from heart defects, particularly atrial septal defects or ventricular septal defects. According to the report, the prevalence of septal heart defects was 0.9% among exposed infants, compared to 0.5% among unexposed infants. Despite these potential dangers, Paxil remains on the market, available to millions of consumers across the country, including pregnant women.
The pregnancy category of Paxil has been elevated from C to D, which means the FDA has reviewed positive human evidence illustrating the drug’s potential to cause significant harm to a fetus when taken during pregnancy. The FDA has also advised physicians to avoid prescribing category D medications like Paxil to pregnant women unless the possible benefits of the drug justify the potential risks to the fetus. If you are currently taking Paxil and you are pregnant or planning to become pregnant, consult your physician as soon as possible. It is never encouraged to discontinue use of a prescription medication without medical consent, 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 alternative to Paxil for treating your condition.
Unfortunately, heart defects are among the most common types of birth defects and are also the leading cause of birth defect-related death among infants. Infants born with heart defects typically require surgery in order to repair the malformation, which can lead to costly medical expenses and an overwhelming financial burden for an already emotionally distressed family. If you or a loved one has suffered from a heart defect and you believe Paxil to be the cause, contact a Paxil attorney as soon as possible to discuss your legal options. You may have grounds to file a Paxil lawsuit against GlaxoSmithKline in order to seek financial compensation for your injuries, the medical expenses associated with injury treatment, and the pain and suffering endured by you and your family.
Victims of serious injury potentially associated with the use of a dangerous drug are not at fault. Pharmaceutical companies like GlaxoSmithKline are responsible for producing and marketing safe medications, and should be held liable for any adverse side effects sustained by consumers of their products. Unfortunately, some drug companies intentionally withhold dangerous drug information in order to expedite the FDA approval process and ensure their product is well-received by the public. This deceptive practice puts millions of consumers at risk of suffering severe injury, illness and even death, which could have been avoided had the drug company taken the appropriate steps to avoid unnecessary harm. The only way to protect your rights and collect the compensation you deserve is to hire an experienced Paxil lawyer to represent your case. Defective drug litigation can be a complicated process, but with the help of a knowledgeable Paxil attorney, victims of alleged Paxil birth defects can feel confident that their case is in good hands.