Developmental Delay - Consumer Justice Foundation

Developmental Delay

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Tegretol and Developmental Delay

Tegretol belongs to a class of pharmaceutical medications called anticonvulsants, which have quickly become the most commonly prescribed drugs for the treatment of epileptic seizures. In recent years, Tegretol and other anticonvulsants have been approved for additional purposes and have even been prescribed for off-label uses when the treatment is deemed appropriate by physicians. Tegretol was approved by the FDA in 1974 and has since been used in the treatment of neuropathic (nerve) pain, epilepsy, and the manic phase of bipolar disorder. The active ingredient in Tegretol is carbamazepine, and the drug functions by slowing down nerve impulses in the brain responsible for causing seizures and pain. Tegretol is currently manufactured by pharmaceutical company, Novartis Pharmaceuticals, and has become increasingly popular as a method of epilepsy treatment.

Epilepsy is a debilitating and dangerous condition especially for pregnant women, since seizures can cause serious side effects for both mother and child. However, according to an emerging body of research, women who take anticonvulsant drugs while pregnant may significantly increase their risk of giving birth to an infant with one or more major birth defects. Finding an appropriate treatment for pregnant women with epilepsy has become extremely challenging for many healthcare providers in recent years because of the allegedly harmful nature of anticonvulsants. Unfortunately, according to the Journal of the American Medical Association, the number of anticonvulsants on the market has increased drastically since the 1990s.

Developmental Delay Described

The process of child development involves learning and mastering skills like crawling, sitting, walking and talking. The natural progression of a child’s development is marked by developmental milestones, which children are expected to reach by a certain age. Developmental delay occurs when a child has not reached one or more of these milestones by the expected time period. For example, if children are expected to learn to walk between nine and fifteen months, and a 20-month-old child has still not learned to walk, this child would likely be diagnosed with developmental delay.

Types of Developmental Delay

There are five different areas of development which can be affected by developmental delay, including:

  • Cognitive development
  • Speech and language development
  • Social and emotional development
  • Fine motor skill development
  • Gross motor skill development

Developmental delay can occur in all five areas of development or may just affect one or two of these areas at a time. Unfortunately, growth in each area of development is related to growth in the other areas, which means difficulty in one area of development is likely to result in delays in other areas.

Developmental Delay Prognosis

There are different general warning signs which may signify developmental delay, including difficulties in behavior, vision, hearing and gross motor skills. Children suffering from developmental delay may benefit from early intervention services, which are specifically tailored to meet a child’s individual needs, and can provide support to families in order to enhance a child’s development. Some examples of these services include occupational therapy, audiology, medical services, educational programs, physical therapy, and speech and language therapy. Early diagnosis of this condition can help affected children progress more quickly and overcome the impact of their developmental delays. Generally, children who experience developmental delays can lead independent and productive lives as adults.

Potential Tegretol Birth Defects and Studies

One of the most recent Tegretol side effect studies was published in the British Medical Journal in 2010. Researchers involved in this study reviewed eight cohort studies involving 2,680 women who received Tegretol treatment during pregnancy. The children born to these women were then observed for adverse side effects, namely birth defects. According to the report, 3.3% of infants born to women who took Tegretol during the first trimester of pregnancy developed major birth defects. Furthermore, infants exposed to Tegretol during pregnancy were 2.6 times more likely to develop spina bifida, compared to unexposed infants.

In 1989, the New England Journal of Medicine published a study in which researchers sought to determine whether and to what extent Tegretol is teratogenic, a term defined as the ability for a drug to interrupt fetal development and cause fetal malformations. According to the study, the teratogenicity of Tegretol was illustrated by the birth defects present in infants exposed to the drug during pregnancy. Of the thirty-five children observed, 11% were born with craniofacial malformations, 26% developed hypoplasia of the nails, and 20% suffered from developmental delay.

In 2001, the NEJM published an additional study which examined the teratogenicity of anticonvulsant drugs like Tegretol. This study observed over 100,000 women who became pregnant while taking an anticonvulsant, and these women were then divided into three groups based on level of anticonvulsant exposure during pregnancy. 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 the report, the prevalence of birth defects among infants exposed to one anticonvulsant in utero was 20.6%, compared to 28% among infants exposed to two or more anticonvulsants, and 8.5% among unexposed infants. Researchers involved in this study concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero.

Tegretol Use During Pregnancy

Tegretol has been classified as a pregnancy category D medication, which means there is positive human evidence of the drug’s potential to cause serious harm to a fetus when taken during pregnancy. The FDA has also 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 physician as soon as possible. You should never suddenly stop taking a prescription medication, 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 alternative to Tegretol for treating your condition.

A Tegretol Attorney Can Help

Birth defects like developmental delay can have lasting effects on a child’s growth and development throughout childhood and even adulthood. Children suffering from developmental delay may fall behind in school or lack the skills necessary to form critical social and personal relationships. If you or a loved one has suffered from a birth defect which you believe to be associated with Tegretol, contact a Tegretol attorney to discuss your legal options. You may have grounds to file a Tegretol lawsuit against 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. Defective drug lawsuits also bring public attention to the potentially hazardous nature of certain medications, possibly preventing further drug-related injury in the future.

Victims of serious injury resulting from the proper use of a dangerous drug are not at fault and should not be held accountable for the resulting consequences. Drug companies like Novartis are responsible for producing safe medications and should be held liable for any serious side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies deny liability for dangerous drug-related injuries in an attempt to protect themselves from negative consequences, such as a drug recall. Not only does this deceptive practice prevent injury victims from receiving the financial compensation they deserve, but it also prevents dangerous drug information from reaching other consumers, potentially leading to further injury and even death.

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