Paxil, manufactured by GlaxoSmithKline, belongs to a class of medications known as SSRIs, or selective serotonin reuptake inhibitors. These prescription antidepressant drugs function by increasing the level of serotonin in the brain, a neurotransmitter responsible for controlling mood. By doing so, these drugs can relieve depression and improve certain mood disorders. Paxil (paroxetine) was approved by the FDA in 1992 to treat individuals with major depressive disorder, and was additionally indicated 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. Despite the popularity of Paxil and other SSRI antidepressants though, the results of recent studies have raised concerns about the safety of these drugs, especially in treating pregnant women. According to extensive research, women who take SSRI antidepressants like Paxil during pregnancy may significantly increase their chances of giving birth to infants with one or more devastating birth defects, including neural tube birth defects.
Neural tube birth defects occur as a result of a malformation of the neural tube, a structure present during fetal development which is the precursor for the child’s central nervous system. When there is a problem during the fusion of the neural tube cells, a neural tube defect may occur, characterized by an opening in the skull or spinal column. Unfortunately, neural tube defects are also typically accompanied by damage to the brain and spinal cord, which can result in problems with movement, learning and development. Children with neural tube birth defects often exhibit symptoms like incontinence, paralysis, lack of concentration and coordination, muscle weakness, loss of sensation in parts of the body, allergies, stiff joints and difficulty solving problems.
Spina bifida is one of the most common types of neural tube birth defects, occurring when the vertebrae overlying the spinal cord fail to fuse together. This creates an opening in the spinal column through which the spinal cord may actually protrude, in severe cases. The most common and least severe form of this condition is called spina bifida occulta. Many children with this malformation may be asymptomatic, and often, the only visible sign of the condition is a small birthmark or patch of hair at the actual site of the defect. Spina bifida cystica, on the other hand, is the most severe form of spina bifida, and is characterized by a fluid-filled cyst which protrudes from the affected child’s back and may contain the spinal cord, nerves, or both.
Anencephaly is one of the most devastating forms of neural tube birth defect. This condition occurs when the head end of the neural tube fails to close completely, resulting in the absence of a large part of the brain and skull. Children with anencephaly are born without a forebrain, which is the largest part of the brain, and a cerebrum, which is responsible for senses, movement and thinking. In some cases, the remaining brain tissue may be exposed. These children are often born deaf, blind, unconscious and unable to feel pain. Although infants with anencephaly sometimes display reflex actions like breathing and response to touch, the lack of a functioning cerebrum makes it impossible for the child to ever regain consciousness. Most children born with this condition only survive a few hours or days after birth.
In 2005, the FDA issued a public health advisory warning patients and healthcare providers about the possible connection between the use of paroxetine (Paxil) during pregnancy and an increased risk of congenital birth defects, namely heart defects. The notice also increased the pregnancy category of Paxil from C to D. This FDA warning was issued after the review of information provided by two unpublished epidemiology studies. According to the first study, which collected data from a Swedish national pregnancy registry, infants whose mothers took Paxil during early pregnancy were nearly twice as likely to be born with a heart defect, compared to the entire registry population. The second study, which was conducted in the United States, indicated that infants born to women who took Paxil during the first trimester of pregnancy had a 1.5-fold increased risk of heart defects and a 1.8-fold increased risk of congenital birth defects overall, compared to infants whose mothers took other antidepressants while pregnant
The FDA issued another public health advisory in 2006 after reviewing the results of a New England Journal of Medicine study published earlier that year. According to researchers, women who took SSRI antidepressants like Paxil after the twentieth week of pregnancy were a shocking six times more likely to give birth to an infant with PPHN, or persistent pulmonary hypertension of the newborn, compared to women who didn’t take an SSRI while pregnant. PPHN is a life-threatening heart and lung condition in which an infant’s circulation continues to bypass the lungs after birth, depriving the body of oxygen. The NEJM published two additional studies in 2007, the first of which suggested that infants exposed to SSRI antidepressants like Paxil 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 neural tube birth defects, cleft lip and cleft palate. According to the second study, infants exposed to SSRIs like Paxil in utero were more than twice as likely to be born 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 concerning the drug’s potential to cause significant, unreasonable harm to a fetus when taken during pregnancy. If you are currently pregnant or planning to become pregnant and you are taking Paxil, consult your physician immediately. It may not be safe to suddenly discontinue use of a prescription medication, as this may cause harm to both you and your child. However, with your doctor’s help, you may be able to find a safer alternative to Paxil for treating your condition.
Neural tube birth defects can cause severe and even life-threatening complications for an affected child, and research has shown that the use of SSRI antidepressants like Paxil during pregnancy may increase an infant’s risk of developing one or more of these defects. Unfortunately, according to the Journal of the American Medical Association, more than 80,000 pregnant women are prescribed SSRI antidepressants in the United States in any given year. If you or a loved one has suffered from a neural tube birth defect and you believe Paxil to be the cause, contact a Paxil attorney 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, medical expenses, and pain and suffering.
Victims of serious injuries resulting from the use of a dangerous drug are not at fault, and should not be held responsible for the resulting consequences. Drug manufacturing companies like GlaxoSmithKline are expected to produce and market safe medications, and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies deny liability for defective drug injuries in order to avoid negative consequences, such as a drug recall. Not only does this prevent the injured victim from collecting the compensation he deserves, but it also puts millions of other consumers at risk for severe injury, illness and even death. The only way for victims of alleged Paxil birth defects to protect their rights and stand up to big drug companies is to hire a qualified Paxil lawyer to represent their case.