Tegretol

Tegretol side effects may be resposible for birth defects when used during pregnancy and Tegretol attorneys are filing lawsuits on behalf of affected families.  Contact a Tegretol lawyer and explore your  Tegretol lawsuit options if your child was born with birth defects.

Use of the anticonvulsant medication, Tegretol, during pregnancy may be linked to an increased risk of major side effects, including serious birth defects among exposed infants and fatal skin reactions among some Tegretol patients. Tegretol has been available in the U.S. since it garnered FDA approval in 1974 and is commonly prescribed to patients suffering from epilepsy, neuropathic (nerve) pain, and the manic phase of bipolar disorder. The active ingredient in Tegretol is carbamazepine, and the drug works by inhibiting nerve impulses that cause pain and seizures. Tegretol is currently manufactured by drug company Novartis Pharmaceuticals. Although Tegretol has been on the U.S. market for nearly forty years, recent studies have raised serious doubts about the safety of Tegretol, especially in treating pregnant women or women of childbearing age. If you or a loved one has suffered from a potential Tegretol side effect, contact a Tegretol attorney to discuss your legal options.

Tegretol Side Effects

According to recent Tegretol side effect studies and FDA warnings, Tegretol use may be linked to the development of severe and possibly fatal instances of skin conditions called Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Both SJS and TEN are life-threatening skin disorders caused by an infection or an allergic reaction in response to certain pharmaceutical medications. In patients with SJS or TEN, cell death causes the epidermis to separate from the dermis. Both SJS and TEN commonly begin with flu-like symptoms, progressing quickly to a painful rash and blisters that cover the body, and eventually causing the top layer of skin to die and shed from the body. The main difference between SJS and TEN is the percentage of skin involvement.

Potential Tegretol Birth Defects

According to a number of studies, infants born to women who take the anticonvulsant Tegretol while pregnant may have a significantly increased risk of developing birth defects like:

  • Spina bifida
  • Cleft palate
  • Heart defects
  • Cleft lip
  • Limb defects
  • Developmental delay
  • Hypospadias
  • Hypoplasia of the fingers
  • Hypoplasia of the midface
  • Skeletal defects
  • Growth retardation

In light of the potential for Tegretol to cause severe birth defects, the FDA has classified the anticonvulsant drug as a pregnancy category D medication. This means there is positive human evidence of the drug's potential to cause serious harm to a fetus when taken during pregnancy. If you are currently taking Tegretol and you are pregnant or planning to become pregnant, consult your physician to discuss alternative treatment options.

Tegretol Studies and FDA Warnings

In 2001, the New England Journal of Medicine published a study in which researchers sought to examine the possible link between anticonvulsant drugs like Tegretol and serious birth defects among infants. The study screened over 100,000 pregnant women between 1986 and 1993 in order to form separate groups of women who took one or more anticonvulsant drugs like Tegretol during pregnancy. Of the women who took only one anticonvulsant, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol) and six took valproic acid (Depakote). According to the report, 20.6% of infants exposed to one anticonvulsant in utero developed major birth defects, compared to 28% of infants exposed to two or more anticonvulsants, and 8.5% of unexposed infants. Researchers also reported that spina bifida was the most common birth defects in children whose mothers took Depakote in combination with Tegretol while pregnant.

Between 2003 and 2008, the Health Sciences Authority received 290 cases of drug-induced SJS and TEN. Carbamazepine (Tegretol) was one of the most commonly suspected drugs, accounting for 53, or 18%, of the cases. These 53 patients ranged from age one to eighty-eight and doses of the drug taken varied from 100mg to 600mg daily. The onset of adverse reactions ranged from one day to three months after starting carbamazepine treatment. Recently, carbamazepine-induced SJS and TEN were found to be associated with a certain allele, commonly occurring in patients with ancestry across broad areas of Asia. In 2007, the FDA issued a safety alert warning patients and healthcare professionals about the risk of dangerous or even fatal skin reactions, like Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, in patients taking Tegretol.

Tegretol Attorneys for Side Effects

The side effects potentially associated with Tegretol use are severe and may even be life-threatening. If you or a loved one has suffered from a side effect or birth defect, which you believe to be linked to Tegretol, contact a Tegretol attorney to discuss your legal options. You may be entitled to financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering endured by you and your family, which you can collect by filing a Tegretol lawsuit against Novartis Pharmaceuticals. Drug companies like Novartis are responsible for the safety and effectiveness of their medications, and should be held accountable for any adverse side effects sustained by consumers of their products. By hiring a Tegretol lawyer to represent their case, victims of potential Tegretol side effects can protect their rights and collect the compensation they deserve.






Prescription Drugs in The News