SSRIs, or selective serotonin reuptake inhibitors, are a specific class of antidepressant medications. Zoloft and other SSRI antidepressants have quickly become some of the most commonly prescribed medications on the U.S. market. Although these drugs were originally designed as a first-line defense against depression, many have been approved for additional indications, and some physicians even prescribe the medications for off-label purposes when they see fit. As of 2007, Zoloft was the most popular antidepressant on the market, with 29.7 million prescriptions filled. The drug is currently manufactured by Pfizer, Inc. and garnered FDA approval in 1991. Since its introduction, Zoloft has been approved for the treatment of major depression, post-traumatic stress disorder, obsessive-compulsive disorder, premenstrual dysphoric disorder, social anxiety disorder and panic disorder. The active ingredient in Zoloft is sertraline, and the drug functions by restoring the level of serotonin in the brain, thereby relieving depression and improving certain mood disorders. Although Zoloft has risen to the top of the antidepressant list, recent research has raised significant concerns about the safety of the drug, especially in treating pregnant women. According to a number of medical studies, women who take Zoloft during pregnancy may significantly increase their risk of giving birth to infants with serious birth defects, including cleft palate.
Cleft palate is a craniofacial birth defect caused by the failure of the palate, or roof of the mouth, to fuse together completely in utero. During normal fetal development, the palate is fully formed during the first trimester of pregnancy. However, if there isn’t enough tissue in the palate area as this structure is forming, a cleft palate may occur. This malformation can affect either the bony front portion of the mouth or the soft back portion of the mouth, and can vary in severity from a small opening at the back of the mouth to a nearly complete separation of the roof of the mouth.
There are a number of complications which may accompany a cleft palate, some of which can cause long-term difficulties for an affected child. For instance, the opening in the roof of the mouth may allow food and liquid to pass from the mouth back through the nose, resulting in significant feeding difficulties. Children with a cleft palate are also more prone to having fluid build up in their ears, which can result in chronic ear infections and even hearing loss. Other difficulties associated with cleft palate include speech and language delay and dental problems like missing or misaligned teeth. Although there are a number of temporary treatment options for children with a cleft palate, the only way to permanently correct the defect is for the child to undergo oral surgery.
In 2006, the FDA issued a public health advisory warning patients and healthcare professionals about the increased risk of a birth defect called PPHN among infants whose mothers take SSRI antidepressants like Zoloft during pregnancy. This notice was released in response to new information provided by a New England Journal of Medicine study published that same year. According to researchers, infants whose mothers took an SSRI like Zoloft after the twentieth week of pregnancy were a shocking six times more likely to be born with PPHN, or persistent pulmonary hypertension of the newborn. PPHN is a severe birth defect in which an infant’s circulation continues to bypass the lungs after birth, thereby supplying an inadequate amount of oxygen to the rest of the body.
The NEJM published two additional studies in 2007, the first of which indicated that infants born to women who took an SSRI like Zoloft during the first trimester of pregnancy were nearly twice as likely to develop birth defects like anal atresia, club foot and limb defects. Researchers also found a possible link between these drugs and cleft palate, neural tube birth defects and cleft lip. According to the second study, infants who were exposed to an SSRI in utero were more than twice as likely to be born with devastating birth defects like omphalocele, craniosynostosis and anencephaly. In 2010, the American Journal of Nursing published a study in which researchers found a nearly two-fold increased risk of heart defects among infants exposed to an SSRI during the first trimester of pregnancy.
The FDA has labeled Zoloft a pregnancy category C medication, which means the drug has the potential to cause serious harm to a human fetus when taken during pregnancy. The FDA has also required all sponsors of SSRI medications to change prescribing information to include the potential risk for PPHN. If you are currently taking Zoloft and you are pregnant or planning to become pregnant, consult your physician immediately. You should never stop taking a prescription medication without medical consent, as this may cause serious harm to you or your child. However, with your doctor’s help, you may be able to find a safer alternative to Zoloft for treating your medical condition.
Although birth defects like cleft palate can often be successfully treated with surgery, the cost of seeking proper birth defect treatment is likely to result in costly medical expenses. Unfortunately, this may be an overwhelming financial burden to families already emotionally distressed by a birth defect diagnosis. If you or a loved one has suffered from a cleft palate and you believe Zoloft to be the cause, contact a Zoloft attorney to discuss the benefits of filing a Zoloft lawsuit against Pfizer. The goal of Zoloft lawsuits and potential Zoloft class action lawsuits is to seek financial compensation for your injuries and medical expenses, as well as the pain and suffering endured by you and your family. Defective drug lawsuits also bring attention to the potential hazards of certain medications, potentially preventing serious injury and death in the future.
While most consumers understand that no drug is 100% safe, they do expect their prescription medications to effectively treat their condition without causing any unnecessary harm. Unfortunately, there are some drugs currently on the market for which the potential risks actually outweigh the possible benefits of the treatment. In fact, some drug manufacturing companies actually conceal the harmful nature of their medications in order to make their products more appealing to consumers. This deceptive practice puts millions of consumers unknowingly at risk of suffering serious injury and even death, just by taking their prescription medications. Without accurate information concerning the benefits and risks of prescription drugs, consumers are robbed of their right to make educated decisions regarding the value of their medications. Only by hiring a qualified Zoloft lawyer can victims of alleged Zoloft birth defects protect their rights and collect the compensation they deserve.
