Tegretol is an anticonvulsant or antiepileptic drug which have been on the market since it garnered FDA approval in 1974. Since its introduction, Tegretol has been widely prescribed for the treatment of epilepsy, particularly tonic-clonic and partial onset seizures, and neuropathic (nerve pain), as well as a form of mood stabilizer for individuals suffering from bipolar disorder. Tegretol's active ingredient is carbamazepine, which functions by slowing down impulses in the brain which are responsible for causing seizure-related disorders. Tegretol is currently manufactured by Novartis Pharmaceuticals and has become one of the most commonly prescribed anticonvulsant drugs on the market.
Regardless of Tegretol's popularity though, several studies have surfaced in recent years identifying a potential connection between the use of Tegretol during pregnancy and the development of major birth defects among infants. According to this research, infants who are exposed to Tegretol in utero may have a significantly increased risk of being born with severe and even fatal birth defects, including heart defects.
A congenital heart defect is a malformation affecting the structure of the heart or the vessels surrounding the heart. Some heart defects obstruct the flow of blood in the heart, while others affect the heart's rhythm or cause blood to flow through the heart is an abnormal manner. While some heart defects are minor and result in few symptoms, others are more severe and affected children may exhibit symptoms like:
Two of the most common types of heart defects are atrial septal defects and a condition called hypoplastic right heart syndrome.
An atrial septal defect is a hole in the wall of the heart separating the right and left atria which allows oxygenated blood from the left atrium to mix with oxygen-poor blood from the right atrium. This mixture increases the amount of blood flowing to the lungs and can lead to serious complications, including an abnormal heart rhythm and issues with how the heart pumps blood. An atrial septal defect also increases a child's chances of suffering from life-threatening conditions like pulmonary hypertension and stroke.
Hypoplastic right heart syndrome is a severe congenital heart defect involving the underdevelopment of the heart's right ventricle, which prevents the structure from containing the correct amount of blood pumped from the right atrium. Even though the ventricle is not formed properly, the heart will continue to attempt to pump blood to the pulmonary valve for transfer to the lungs, which may result in dangerous complications. Infants with hypoplastic right heart syndrome require immediate medical attention, as the heart will begin to fail shortly after birth.
Unfortunately, some studies on antiepileptic side effects have indicated that Tegretol use during the first trimester of pregnancy more than doubles the risk of serious congenital birth defects, particularly heart defects, among infants exposed to the drug. According to a small study involving 210 women who became pregnant while taking Tegretol, the prevalence of heart defects was 2.9 percent, compared to the prevalence of heart defects among unexposed infants, which was 0.7 percent. Another study on antiepileptic side effects published in 2010 in the British Medical Journal reviewed eight cohort studies involving 2,680 women who took carbamazepine (Tegretol) during pregnancy. According to side effect researchers, 3.3% of infants born to women who took Tegretol during the first trimester of pregnancy were born with major birth defects, including spina bifida. More specifically, the report indicated that infants exposed to Tegretol during pregnancy were 2.6 times more likely to develop spina bifida, compared to infants who were not exposed to the drug in utero.
Another revealing side effects study was published in the New England Journal of Medicine in 2001 which sought to examine the adverse effects of Tegretol use during pregnancy on infants exposed to the drug in utero. Over 100,000 women were screened at five Boston-area hospitals between 1986 and 1993 and divided into separate groups of women who took one anticonvulsant during pregnancy, two or more anticonvulsants, and no anticonvulsants during pregnancy. Of the anticonvulsant drugs used in the study, 87 took Dilantin (phenytoin), 58 took Tegretol (carbamazepine), and six took Depakote (valproic acid), among other anticonvulsants. According to the report, 20.6% of infants exposed to one anticonvulsant drug in utero developed birth defects, compared to 28% of infants exposed to two or more anticonvulsants, and 8.5% of unexposed infants. Furthermore, 13.8% of infants exposed to Tegretol (carbamazepine) alone were born with major birth defects, including hypoplasia of the fingers, hypoplasia of the midface, growth retardation, spina bifida, and a skeletal defect called microcephaly. In addition, the prevalence of spina bifida was highest among infants whose mothers took Tegretol with valproic acid, or Depakote. Researchers involved in this study concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero.
If you are currently taking Tegretol and you are pregnant or planning to become pregnant, consult your physician immediately. The FDA has classified Tegretol as a pregnancy category D medication, which means there is positive human evidence of the potential of Tegretol's side effects to cause significant harm to a fetus when taken during pregnancy. The FDA has also advised healthcare providers to avoid prescribing Tegretol to pregnant women unless the possible benefits of Tegretol treatment justify the potential risks to the fetus. You should never stop taking a prescription medication without medical consent, as this may cause further harm, but with your doctor's aid, you may be able to find an alternative method of treatment for your condition.
If you or a loved one has suffered from a heart defect which you believe to be linked to the use of Tegretol, contact a Tegretol attorney for help. You may have grounds to file a Tegretol lawsuit against manufacturing company, Novartis Pharmaceuticals, in order to seek financial compensation for your injuries, the medical expenses associated with treating your injuries, and the pain and suffering endured by you and your family. By filing Tegretol lawsuits or joining potential Tegretol class action lawsuits, families can also bring public attention to the potentially harmful nature of the drug.
Victims of defective drug injuries are not at fault and should not be held accountable for the consequences associated with their injuries. Drug manufacturing companies are expected to produce safe and effective drugs, and to alert the public of any potential adverse side effects of their drugs. Unfortunately, some pharmaceutical companies intentionally conceal this information in order to avoid suffering negative consequences, such as a drug recall. This deceptive practice exposes innocent consumers to serious injuries, illnesses and even death, just by taking prescription medications they believe to be safe. The only way for victims of potential Tegretol birth defects to protect their rights and stand up to big drug companies is to hire an experienced Tegretol lawyer and file a Tegretol lawsuit or join a potential Tegretol class action lawsuit.
Spread the word so women are aware of the risks for both anticonvulsant birth defects and antidepressant birth defects and so families dealing with the hardship and expenses of lifetime care can get financial help from experienced class action attorneys. Learn more about Side Effects from prescription drugs.
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The dangerous side effect of anticonvulsant use during pregnancy is under investigation by lawyers filing lawsuits for birth defects on behalf of mothers that took Dilantin, Depakote, Tegretol and Topamax. This website has no relationship with any of the aforementioned drugs or pharmaceutical companies and is not intended to be medical advice.