Heart Defects - Consumer Justice Foundation

Heart Defects

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Tegretol and Heart Defects

Anticonvulsant drugs like Tegretol were originally designed as a primary treatment for individuals with epilepsy, although many anticonvulsants have been approved for additional purposes since their introduction. Tegretol, for example, was approved by the FDA in 1974 and has since been approved for the treatment of epilepsy, bipolar disorder, and neuropathic (nerve) pain. Tegretol (active ingredient carbamazepine) works by reducing certain nerve impulses in the brain which are responsible for causing pain and seizures. Tegretol is currently manufactured by drug company, Novartis Pharmaceuticals, and has become one of the most commonly prescribed anticonvulsants on the market.

Despite its popularity in treating epilepsy and other medical conditions, Tegretol may be associated with an increased risk of major birth defects among infants when taken during pregnancy. According to a number of credible medical journals, including the New England Journal of Medicine and the British Medical Journal, infants born to women who take anticonvulsants like Tegretol during pregnancy may have a significantly increased risk of developing one or more life-threatening birth defects, including heart defects like atrial septal defects and hypoplastic right heart syndrome.

Heart Defect Symptoms

Heart defects are malformations present at birth which affect the structure of the heart or the blood vessels surrounding the heart. Some heart defects disturb the heart’s rhythm, while others obstruct the flow of blood in the heart, or cause blood to flow through the heart in an irregular manner. Some heart defects are minor and may never be detected throughout the affected child’s life. Unfortunately, more than half of children with heart defects require immediate treatment in order to prevent additional, life-altering complications. Although heart defect symptoms typically vary on a case-by-case basis, the most common symptoms of this type of malformation include:

  • Poor growth
  • Poor feeding
  • Shortness of breath
  • Cyanosis (bluish skin tint)
  • Heart murmur
  • Respiratory infections
  • Atrial Septal Defect

One of the heart birth defects potentially associated with Tegretol use during pregnancy is an atrial septal defect, which is a hole in the wall of the heart separating the left and right atria, or upper chambers of the heart. This hole allows oxygenated blood from the left side of the heart to mix with oxygen-poor blood from the right side of the heart, ultimately increasing the amount of blood flowing to the lungs. An excessive amount of blood being pumped to the lungs can result in serious complications, including an abnormal heart rhythm and difficulties with how the heart pumps blood. Children born with an atrial septal defect also have an increased risk of suffering from life-threatening conditions, like stroke and pulmonary hypertension.

Hypoplastic Right Heart Syndrome

Even more dangerous than an atrial septal defect is a severe congenital heart defect called hypoplastic right heart syndrome (HRHS). This condition is characterized by an underdeveloped right ventricle, which prevents that part of the heart from containing the correct amount of blood pumped from the right atrium. Even though the ventricle is malformed, the heart will continue to try to pump blood to the pulmonary valve to be transferred to the lungs. Infants born with HRHS require immediate medical attention to repair the defect, as this malformation can result in dangerous complications for an affected child.

Alleged Tegretol Birth Defects

A number of studies have been conducted in recent years in which researchers have sought to evaluate the potential adverse side effects of anticonvulsant drugs like Tegretol. Even as early as 1989, medical journals like the NEJM were publishing studies whose results revealed the potential for anticonvulsant drugs to cause irreversible injury to infants exposed to the drugs in utero. The NEJM published a study that year in an attempt to examine whether and to what extent Tegretol is teratogenic, a term defined as the ability for a drug to interfere with fetal development and cause fetal malformations. According to researchers involved in this study, the teratogenicity of Tegretol was exhibited by the incidence of birth defects among infants exposed to the drug during pregnancy. The report indicated that, of the thirty-five children observed, 11% developed craniofacial defects, 26% were born with hypoplasia of the nails, and 20% suffered from developmental delay.

Years later, the NEJM published another study (2001) in which researchers ultimately concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero. This study observed over 100,000 pregnant women who took an anticonvulsant during pregnancy, divided into different groups based on extent of anticonvulsant exposure. Of the women who took only one anticonvulsant while pregnant, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproic acid (Depakote). According to researchers, 20.6% of infants exposed to one anticonvulsant developed birth defects, compared to 28% of infants exposed to more than one anticonvulsant, and 8.5% of unexposed infants.

In 2010, the BMJ published a study involving 2,680 women who took Tegretol while pregnant. Researchers observed the children born to these women in order to determine the presence and extent of side effects sustained by infants exposed to Tegretol in utero. According to the study, 3.3% of infants whose mothers took Tegretol during the first trimester of pregnancy were born with major birth defects. Furthermore, children exposed to Tegretol in utero were 2.6 times more likely to develop spina bifida, compared to unexposed infants. Despite extensive research illustrating the alleged harmful nature of Tegretol and other anticonvulsants, a large number of these drugs remain on the market today, available to millions of consumers across the country. In fact, according to the Journal of the American Medical Association, the number of anticonvulsant medications on the market has significantly increased since the 1990s, even after studies have revealed the potential dangers associated with their use.

Tegretol Use During Pregnancy

Tegretol has been labeled by the FDA as a pregnancy category D medication, a category reserved for drugs which positive human evidence has shown may cause serious harm to a fetus when taken during pregnancy. Due to this potential danger, the FDA has advised physicians to avoid prescribing Tegretol to pregnant women unless the possible benefits of the treatment justify the potential risks to the fetus. If you are currently taking Tegretol and you are pregnant or planning to become pregnant, consult your healthcare provider immediately. You should never stop taking a prescription medication without medical consent, as this may cause further harm to you or your child, but with your doctor’s help you may be able to find a safer way to effectively treat your medical condition.

A Tegretol Attorney Can Help

While some heart defects are minor and require little to no treatment, others are extremely dangerous and may lead to death if the affected child doesn’t receive immediate medical care. If you or a loved one has suffered from a heart defect and you believe Tegretol to be the cause, contact a qualified Tegretol attorney to discuss the benefits of filing a Tegretol lawsuit against Novartis Pharmaceuticals. The goal of Tegretol lawsuits and potential Tegretol 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. Unfortunately, some pharmaceutical companies and insurance claims adjusters employ deceptive practices to prevent consumers from collecting the compensation they are entitled to. The only way to protect your rights and stand up to big drug companies is to hire an experienced Tegretol lawyer to represent your case.

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