Hypoplasia and Tegretol

New England Journal of Medicine study shows a higher risk of hypoplasia birth defect affecting babies whose mothers took Tegretol during pregnancy.

One of the most commonly prescribed anticonvulsant drugs on the U.S. market is Tegretol, a medication manufactured by pharmaceutical company, Novartis Pharmaceuticals. Tegretol was approved by the FDA in 1974 and has since been prescribed to individuals suffering from epilepsy, bipolar disorder, and neuropathic (nerve) pain. The active ingredient in Tegretol is carbamazepine, which functions by inhibiting the firing of certain impulses in the brain which are responsible for causing seizure-related episodes. Unfortunately, concerns about the safety of Tegretol have been raised recently because of studies which have established a potential connection between the use of Tegretol during pregnancy and the development of major birth defects among infants. According to research, women who take Tegretol while pregnant may significantly increase their chances of giving birth to infants with one or more severe birth defects, including hypoplasia.

Hypoplasia Described

Hypoplasia is a type of congenital birth defect in which one or more of a child's organs or tissues are underdeveloped due to an inadequate number of cells present during fetal development. Hypoplasia can affect virtually any structure of the body, including the teeth, heart, breasts, lungs, testes, and ovaries, although the types potentially associated with the use of Tegretol are hypoplasia of the fingers, nails and midface.

Hypoplasia of the Fingers

Hypoplasia of the fingers is characterized by abnormally small or underdeveloped fingers or thumbs. Instances of this condition range in severity from a finger that is slightly smaller than normal with all of its structures intact, to a finger that is "floating" with no bone support and attached only by skin to the hand, and a finger that is absent altogether. Children with malformed fingers may have difficulty performing simple tasks like grasping objects and playing with toys. Infants born with hypoplasia of the fingers typically require reconstructive surgery in order to restore the function and appearance of the affected finger.

Hypoplasia of the Nails

Children with hypoplasia of the nails are born with seriously underdeveloped or missing fingernails or toenails. The nails serve a number of purposes, including protecting the nerves and blood vessels located beneath the nail bed. Without properly developed nails, children may suffer from dangerous infections involving the fingers or toes, which can lead to illness or other major complications. While there is no cure for hypoplasia of the nails, there are treatment methods available which may relieve the symptoms associated with this condition.

Hypoplasia of the Midface

A more severe form of hypoplasia is called hypoplasia of the midface, a condition which affects a child's eye sockets, upper jaw and cheekbones. Because the rest of the child's face is formed normally, the underdeveloped areas appear sunken into the face and result in bulging eyes and a protruding lower jaw. Children born with hypoplasia of the midface typically require several reconstructive surgeries over a long period of time which gradually restore the appearance and function of the affected child's face.

Tegretol and Birth Defects

Several side effect studies have been conducted in recent years in which a possible connection between Tegretol use and birth defects has been found. In 1989, the New England Journal of Medicine published a study which sought to examine the adverse side effects of Tegretol use during pregnancy on infants exposed to the drug during pregnancy. According to antiepileptic side effect researchers, of the thirty-five infants involved in the study whose mothers took Tegretol while pregnant, 11% developed craniofacial defects including cleft lip and cleft palate, 20% suffered from developmental delay, and 26% were born with hypoplasia of the fingernails.

Another study regarding antiepileptic side effects was published in 2001 in the NEJM which screened over 100,000 women at five Boston-area hospitals between the years 1986 and 1993. These women were divided into three groups, one of which included women who took one anticonvulsant drug during pregnancy, another which included women who took two or more anticonvulsants while pregnant, and another which included women who received no anticonvulsant treatment during pregnancy. Of the anticonvulsant drugs taken, 87 used Dilantin (phenytoin), 58 used Tegretol (carbamazepine), and six took Depakote (valproic acid), among others. According to researchers, 20.6% of infants exposed to one anticonvulsant in utero developed birth defects, compared to 28% of infants exposed to more than one anticonvulsant, and 8.5% of unexposed infants. The birth defects observed in the study included hypoplasia of the fingers, hypoplasia of the midface, growth retardation, microcephaly, and spina bifida, and spina bifida was most prevalent among infants exposed to Tegretol and Depakote (valproic acid). After reviewing these findings, researchers concluded that anticonvulsant drug side effects are one of the most common causes of potential harm to a fetus in utero.

A more recent study on antiepileptic side effects published in the British Medical Journal (2010) reviewed eight cohort studies and involved 2,680 women who took carbamazepine (Tegretol) while pregnant. Researchers reported that 3.3% of infants whose mothers took Tegretol during the first trimester of pregnancy developed major birth defects, particularly spina bifida. In fact, the study indicated that infants born to women who took Tegretol while pregnant were 2.6 times more likely to develop spina bifida, compared to unexposed infants. Despite these potential dangers, Tegretol remains on the market today.

Tegretol Use While Pregnant

If you are pregnant or planning to become pregnant and you are currently taking Tegretol, consult your physician as soon as possible. Tegretol has been classified by the FDA as a pregnancy category D medication, which means the drug's side effects may cause significant harm to a human fetus when taken during pregnancy. The FDA has also advised healthcare providers to avoid prescribing Tegretol to pregnant women unless the possible benefits of the drug outweigh the potential risks to the fetus.

Hypoplasia Attorneys Can Help

If you or a loved one has suffered from a serious birth defect like hypoplasia of the fingers, hypoplasia of the nails, or hypoplasia of the midface and you believe Tegretol to be the cause, contact a Tegretol attorney as soon as possible. You may be entitled to reimbursement for your injuries, medical expenses and pain and suffering, which you can collect by filing a Tegretol lawsuit or joining a potential Tegretol class action lawsuit against pharmaceutical company, Novartis Pharmaceuticals. Tegretol lawsuits and potential Tegretol class action lawsuits also bring critical attention to the importance of safe medications and the need for more harsh restrictions on the dangerous drugs already on the market.

Tegretol lawyers want you to know that you are not to blame for any injuries you may have sustained due to the use of a dangerous drug. Drug manufacturing companies are responsible for the safety of their medications even after they enter the market, and should be held accountable for any adverse side effects caused by their products. With the help of an experienced Tegretol lawyer, victims of alleged Tegretol birth defects can hold the responsible party liable for their injuries and collect the compensation they deserve.