PPHN - Consumer Justice Foundation

Zoloft and PPHN Birth Defects

Zoloft, manufactured by Pfizer, Inc., 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 relieve depression and improve certain mood disorders. Zoloft (sertraline) was approved by the FDA in 1991 and has since been used in the treatment of major depression, obsessive-compulsive disorder, social anxiety disorder, premenstrual dysphoric disorder, panic disorder, and post-traumatic stress disorder. Despite the fact that Zoloft was the most commonly prescribed antidepressant on the market in 2007 with 29.7 million prescriptions filled, recent research has raised concerns about the safety of the medication, especially in treating pregnant women. According to a number of studies, infants born to women who take Zoloft while pregnant may have a significantly increased risk of developing one or more major birth defects, including persistent pulmonary hypertension of the newborn.

Persistent Pulmonary Hypertension of the Newborn

Persistent pulmonary hypertension of the newborn, or PPHN, is a serious birth defect in which a child’s circulation continues to bypass the lungs after birth, depriving the body of oxygen. Under normal circumstances, as the fetus is developing inside the womb, the lungs aren’t necessary in the exchange of oxygen because the placenta provides the baby with oxygen through the umbilical cord. Because of this, the lungs need little blood supply and the baby’s circulation bypasses the lungs. Once the baby is born however, the body must adapt to breathing air and the lungs are required in order for the exchange of oxygen and carbon dioxide to occur.

In infants with PPHN, the body fails to make this change and the blood flow continues to bypass the lungs, causing an inadequate amount of oxygen to be supplied to the rest of the body. Although the child is able to breathe, oxygen in the breathed air will not reach the bloodstream, resulting in symptoms like rapid breathing, rapid heart rate, respiratory distress, cyanosis (blue tint to the skin), heart murmur, and low oxygen levels even while receiving oxygen treatment.

PPHN Treatment and Prognosis

The main goal of PPHN treatment is to maximize the amount of oxygen being delivered to the body’s organs and tissues in order to prevent damage. Common treatment methods for this condition include delivery of 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. With prompt diagnosis and treatment, some instances of PPHN may be treatable and reversible. Unfortunately, some children may continue to deliver insufficient supplies of oxygen to the rest of the body, even with treatment. This may result in devastating complications like kidney failure, heart failure, seizures, shock, brain hemorrhage and even death.

Zoloft Birth Defect Studies and FDA Warnings

In 2006, the FDA issued a public health advisory alerting patients and healthcare professionals about the increased risk of PPHN among infants exposed to SSRI antidepressants like Zoloft during pregnancy. The FDA also required all sponsors of SSRI antidepressants to change drug prescribing information to include the potential risk for PPHN. These decisions were made by the FDA in response to a study published in the New England Journal of Medicine in 2006. According to this study, infants whose mothers took an SSRI drug like Zoloft after the twentieth week of pregnancy were an alarming six times more likely to be born with PPHN, compared to unexposed infants. Researchers indicated that up to twelve out of 1,000 infants involved in the study developed PPHN, compared to the expected rate among the general population, which is one to two out of 1,000.

The following year, the NEJM published two additional SSRI birth defect studies. The first study determined that infants exposed to an SSRI antidepressant like Zoloft during the first trimester of pregnancy were nearly twice as likely to be born with birth defects like anal atresia, club foot and limb defects. Researchers also found a connection between SSRIs and cleft palate, cleft lip and neural tube birth defects. According to the second study, infants born to women who took an SSRI while pregnant were more than twice as likely to develop catastrophic birth defects like anencephaly, omphalocele and craniosynostosis. In 2010, a study published in the American Journal of Nursing concluded that infants exposed to SSRI antidepressants like Zoloft during the first trimester of pregnancy were nearly twice as likely to be born with serious heart defects, particularly atrial and ventricular septal defects.

Zoloft Use While Pregnant

Zoloft has been labeled by the FDA as a pregnancy category C medication, which means the drug may cause serious harm to a 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 terminate use of a prescription medication without medical consent, as this may cause additional harm to you or your child. However, with your doctor’s help, you may be able to find a safer way to treat your condition.

A Zoloft Attorney Can Help

Despite the fact that these studies have indicated a potential connection between SSRI antidepressants like Zoloft and life-altering birth defects, physicians continue to prescribe these drugs to consumers across the country, including pregnant women. In fact, according to the Journal of the American Medical Association, over 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 PPHN, which you believe to be associated with the use of Zoloft, contact a Zoloft attorney as soon as possible. You may be entitled to reimbursement for your injuries and medical expenses, which you can collect by filing a Zoloft lawsuit against Pfizer.

Victims of serious injury associated with the use of a dangerous 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 deny liability for dangerous drug injuries in order to avoid negative consequences, such as a drug recall. This deceptive practice puts millions of consumers unknowingly at risk of suffering serious injuries and even death, just by taking their prescription medications. Consumers have a right to be notified of all benefits and risks associated with their medications, so they can make an educated decision to continue or discontinue use of the drug. By withholding dangerous drug information, drug companies rob consumers of this right. By hiring a qualified Zoloft lawyer, victims of alleged Zoloft birth defects can protect their rights and stand up to the misleading practices of pharmaceutical companies.

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