Hypoplasia - Consumer Justice Foundation


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Tegretol and Hypoplasia

Tegretol falls into the category of anticonvulsant medications, which were initially developed as the first-line defense against epilepsy. In recent years though, many anticonvulsants have proven effective in the treatment of additional conditions, for which some have garnered FDA approval. Tegretol was approved by the FDA in 1974 and has since been approved for the treatment of epilepsy, neuropathic (nerve) pain, and the manic phase of bipolar disorder. Tegretol (carbamazepine) functions by inhibiting nerve impulses in the brain which are responsible for causing seizures and pain. Tegretol is currently manufactured by Novartis Pharmaceuticals, and has become increasingly prescribed by physicians in the United States.

Unfortunately, a number of studies conducted in the past few decades have identified the use of anticonvulsants during pregnancy, including Tegretol, as a potential risk factor for the development of serious birth defects among infants. Unfortunately, because many birth defects are established during the first trimester of pregnancy, and because nearly half of all pregnancies are unplanned, all women of childbearing age who take Tegretol may be at risk of causing irreversible harm to their unborn child before they are even aware they are pregnant. Among these alleged Tegretol birth defects is a potentially life-altering condition called hypoplasia.

What is Hypoplasia?

Hypoplasia is an overarching term used to describe the underdevelopment of one or more of a child’s organs or tissues. This birth defect occurs when there is an insufficient number of cells present in the affected area during fetal development. Although hypoplasia can essentially affect any organ or tissue in the body, including the heart, teeth, ovaries, testes, and lungs, the types of hypoplasia potentially associated with the use of Tegretol include hypoplasia of the midface, hypoplasia of the nails, and hypoplasia of the fingers.

Hypoplasia of the Midface

In children born with hypoplasia of the midface, the cheekbones, upper jaw and eye sockets fail to develop properly in utero, resulting in a significantly abnormal appearance. Because of this underdevelopment, parts of the face may appear sunken, the eyes may appear to bulge out of their sockets, and the lower jaw is typically more protrusive than normal, preventing the upper teeth from meeting the lower teeth. In some cases, hypoplasia of the midface may be so severe that affected individuals may develop severe snoring and sleep apnea, a condition in which a lack of air prevents the person from sleeping well because they are constantly waking up in the middle of the night.

Hypoplasia of the Nails

Hypoplasia of the nails is a birth defect in which a child is born with severely underdeveloped or missing fingernails or toenails. This condition is particularly dangerous because the nails serve a number of important purposes, including providing protection for the blood vessels and nerves located beneath the nail bed. Without properly formed nails, children may develop serious infections affecting their fingers or toes, which can lead to life-threatening illness or other complications. There is currently no cure for hypoplasia of the nails and treatment is typically intended to alleviate the symptoms of this condition.

Hypoplasia of the Fingers

Children with hypoplasia of the fingers are born with abnormally small or underdeveloped fingers or thumbs. This birth defect can range in severity from a finger that is smaller in normal but has all its internal structures intact, to a finger that has no bone support and is attached to the hand only by skin, to a finger or thumb that is absent altogether. While hypoplasia of the fingers typically presents no serious danger to the affected child, children born with malformed fingers may suffer from difficulties performing simple tasks like playing with toys and grasping objects.

Alleged Tegretol Birth Defects and FDA Warnings

The FDA has advised physicians to avoid prescribing Tegretol to pregnant women unless the possible benefits of the drug justify the potential risks to the fetus. This FDA decision was based upon revealing information gathered from Tegretol side effect studies in which researchers found an increased risk of birth defects among infants exposed to Tegretol during pregnancy. For example, the New England Journal of Medicine published a study in 1989 which illustrated Tegretol’s potential teratogenicity, a term describing a drug’s ability to interrupt fetal development and cause fetal malformations. Of the thirty-five children observed in the study who were exposed to Tegretol in utero, 26% developed hypoplasia of the nails, 20% suffered from developmental delay, and 11% were born with craniofacial defects.

In 2001, the NEJM published another study with the goal of examining the teratogenicity of anticonvulsant drugs like Tegretol. Researchers reviewed the pregnancies of over 100,000 women who were divided into groups based upon the extent of their exposure to anticonvulsant drugs while pregnant. Of the women who took only one anticonvulsant during pregnancy, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproic acid (Depakote). The report indicated that 20.6% of infants exposed to one anticonvulsant were born with birth defects, compared to 28% of infants exposed to more than one anticonvulsant, and 8.5% of unexposed infants. Among the observed side effects were birth defects like hypoplasia of the midface, hypoplasia of the fingers, growth retardation, spina bifida, and microcephaly. After reviewing these results, researchers concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero.

Tegretol During Pregnancy

The FDA has labeled Tegretol a pregnancy category D medication, which means there is positive human evidence of the drug’s potential to cause significant, unreasonable harm to a fetus when taken during pregnancy. If you are currently pregnant or planning to become pregnant, and you are taking Tegretol, consult your physician as soon as possible. You should never stop taking a prescription medication without medical consent, as this may cause additional harm to you or your child, but with your doctor’s help you may be able to research and choose a new method of treatment for your condition.

A Tegretol Attorney Can Help

Many forms of hypoplasia require surgery in order to correct the defect and repair the affected body part. Hypoplasia of the midface is a particularly serious birth defect, as treatment involves several reconstructive surgeries performed over a long period of time in order to gradually restore the affected child’s face to its normal function and appearance. Unfortunately, medical care to this extent will likely result in costly medical bills, which can be an overwhelming financial burden for a family already emotionally compromised by a birth defect diagnosis. If you or a loved one has suffered from hypoplasia and you believe Tegretol to be the cause, contact a Tegretol attorney to discuss your legal options. You may be entitled to financial compensation for your injuries, medical expenses, and pain and suffering, which you can collect by filing a Tegretol lawsuit against Novartis Pharmaceuticals.

The FDA measures the value and safety of a medication by determining whether or not the possible benefits of the treatment outweigh the potential hazards involved in taking the drug. However, this value can only be accurately evaluated if all drug information is provided by the pharmaceutical company. Unfortunately, some drug companies intentionally withhold dangerous drug information in order to prevent negative consequences, such as a drug recall. This deceptive practice puts millions of consumers at risk of suffering life-altering injury and even death, without their knowledge. The only way to protect yourself from further harm at the hands of big drug companies is to hire a qualified Tegretol lawyer to represent your case.

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