Zoloft belongs to a class of prescription antidepressant medications called SSRIs, or selective serotonin reuptake inhibitors. These drugs function by restoring the level of serotonin in the brain, a neurotransmitter responsible for controlling mood, thereby relieving depression and improving certain mood disorders. Zoloft (sertraline) garnered FDA approval in 1991 and has since been approved for the treatment of major depression, premenstrual dysphoric disorder, panic disorder, obsessive-compulsive disorder, social anxiety disorder, and post-traumatic stress disorder. Zoloft is currently manufactured by pharmaceutical giant, Pfizer Inc. and, since 2007, has been considered the single most commonly prescribed antidepressant on the U.S. market.
Regardless of the popularity of Zoloft and other SSRIs in treating depression and other mood disorders, concerns have been raised recently regarding the safety of these medications, especially in treating pregnant women. According to a number of credible studies, women who take SSRI antidepressants like Zoloft during pregnancy may significantly increase their risk of giving birth to infants with one or more major birth defects, including anal atresia.
Anal atresia, also known as imperforate anus, is a congenital birth defect characterized by a missing or blocked opening to the anus. The anus is the opening to the rectum through which stools leave the body, and this defect occurs as a result of a fetal malformation. In some instances, the rectum may end in a blind pouch that doesn’t connect to the colon, and in others, it may have openings to the urethra, bladder, the base of the penis in boys, or the vagina in girls. The most common symptoms of anal atresia include a swollen abdomen, failure to pass stool within 24-48 hours after birth, and the passage of stool out of the urethra, base of the penis or vagina.
In order to effectively treat anal atresia, the child must undergo reconstructive surgery. If the rectum connects with other organs, these may need to be repaired as well. Infants who receive prompt treatment for this condition typically make a full recovery. However, even with treatment, some infants may continue to suffer from difficulties like incontinence, constipation and intestinal blockage. Unfortunately, anal atresia is often accompanied by other birth defects, so children with this malformation should be immediately tested for defects of the genitals, spine and urinary tract.
In 2006, the FDA issued a public health advisory alerting patients and healthcare providers about the increased risk of PPHN among infants exposed to SSRI antidepressants like Zoloft during pregnancy. This warning came on the heels of a New England Journal of Medicine study published that same year. Researchers involved in the study determined that infants whose mothers took an SSRI antidepressant like Zoloft after the twentieth week of pregnancy were a shocking six times more likely to be born with 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, depriving the body of oxygen. After this study was released, the FDA also required all sponsors of SSRIs to change prescribing information to reflect the potential risk for PPHN.
In 2007, the NEJM published two additional studies in which researchers sought to examine the adverse side effects of fetal exposure to SSRI antidepressants. According to the first study, 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, limb defects and club foot. Researchers also found a potential link between these drugs and neural tube birth defects, cleft lip and cleft palate. The second study indicated that infants whose mothers took an SSRI while pregnant 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 which indicated that infants exposed to SSRIs during the first trimester of pregnancy were nearly twice as likely to suffer from serious heart defects, namely atrial and ventricular septal defects.
The FDA has classified Zoloft as a pregnancy category C medication, which means it has the potential to cause harm to human fetus when taken during pregnancy. If you are currently taking Zoloft and you are pregnant or planning to become pregnant, consult your physician to discuss alternative treatment options. It is never advised to discontinue use of a prescription medication without medical consent, as this may cause further damage to you or your child. However, with the aid of your healthcare provider, you may be able to find a safer way to treat your condition.
SSRI antidepressants have the potential to cause significant pain and suffering for an affected child and his family. Unfortunately, according to the Journal of the American Medical Association, more than 80,000 pregnant women are prescribed SSRI antidepressants like Zoloft in the United States in any given year. If you or a loved one has suffered from anal atresia, and you believe Zoloft to be the cause, contact a Zoloft attorney to discuss your legal options. You may be entitled to reimbursement for your injuries, medical expenses, and pain and suffering, which you can collect by filing a Zoloft lawsuit against Pfizer. Defective drug lawsuits also bring much-needed attention to the importance of safe medications and the need for more strict regulations on the dangerous drugs already on the market.
Victims of serious injury resulting from the use of a defective drug are not at fault. Drug manufacturing companies like Pfizer are responsible for the safety of their medications even after they enter the market, and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies are aware of the hazardous nature of their medications and intentionally conceal this information in order to avoid negative consequences, such as a drug recall. This deceptive practice puts millions of consumers at risk of suffering serious injury, illness and even death, with could have been avoided had the drug company taken the appropriate steps to prevent unnecessary harm. If you think your injuries are associated with the use of Zoloft, the only way to protect your rights and collect the compensation you deserve is to hire a qualified Zoloft lawyer to represent your case.