Depakote and Developmental Delay
Depakote is a prescription medication which falls into the category of anticonvulsant drugs, and was originally developed as a treatment option for individuals with epilepsy. Depakote was initially approved by the FDA in 1983 to treat absence and partial seizures associated with epilepsy. In 1995, the FDA added an indication for the prevention of migraine headaches, and a year later, included the treatment of bipolar disorder as well. Depakote is made up of equal parts sodium valproate and valproic acid, and functions by slowing down the firing of impulses in the brain which are responsible for causing seizure-related episodes. The drug is currently manufactured by pharmaceutical company, Abbott Laboratories.
Unfortunately, recent studies have indicated a potential connection between Depakote and major birth defects in infants exposed to the drug in utero. More specifically, research has suggested that infants born to women who take Depakote while pregnant may have a significantly increased risk of developing severe and life-altering birth defects. Among these birth defects are serious neurological defects like developmental delay. More information regarding Depakote and developmental delay, as well as the process of contacting a Depakote lawyer and filing a Depakote lawsuit can be found below.
Signs of Developmental Delay
An infant’s progression along the predetermined course of development can be measured by observing the point at which the child reaches certain developmental milestones. Slow physical or mental growth, or considerable deviation from these milestones may lead to a diagnosis of developmental delay. For example, children are typically expected to begin to walk between nine and fifteen months of age. If a child reaches twenty months and still hasn’t learned to walk, developmental delay may be suspected. Any of the five areas of development, which include speech and language development, fine motor skill development, gross motor skill development, social and emotional development, and cognitive development, can be affected by delays. Unfortunately, because children need to develop certain skills before they can learn new skills, developmental delay in one skill area may lead to delays in one or more additional areas as well. Some of the complications most often associated with developmental delay include mental deficiencies, speech and language delay, and Down syndrome.
Mental deficiencies are often referred to as mental retardation and are typically characterized by an impairment in intelligence and behavior, resulting in a limitation in performance. In order for a child to be diagnosed as mentally deficient, there must be a deficit in two or more of the following areas:
- Social skills
- Functional academics
- Home living
- Health and safety
Children who suffer from a mental deficiency exhibit different symptoms, depending upon the severity of the condition and the age of the affected child. For example, mentally deficient teenagers may only reach the academic equivalence of a middle school-aged child. Children with a severe mental deficiency may have difficulty learning to speak and may only be able to perform limited self-care tasks. Less serious instances may be illustrated by a difficulty in recognizing social conventions and forming peer relationships.
Speech and Language Delay
Children who experience a speech delay may have issues verbally expressing language, while language delay may be exhibited by the inability of a child to understand and be understood by others. Speech and language delay is characterized by symptoms particular to the child’s age and expected level of development. For example, children between the ages of 12 and 24 months who experience speech and language delay may be unable to imitate sounds, use gestures, and understand simple verbal requests. By the age of two, developmentally delayed children may be incapable of following simple directions, repeating certain sounds or words, and imitating speech or actions.
Infants born with Down syndrome typically suffer from delays in both mental and physical development which may vary from child to child, but are often easily recognizable. Many children with this condition are born with physical abnormalities like a protruding tongue, small ears, upward slanted eyes, and a flat facial profile. Some of the physical issues experienced by children with Down syndrome include feeding problems, slow growth, constipation and low muscle tone. Mental difficulties present in children with this condition include intellectual impairment and delayed developmental milestones, like crawling and walking. However, while children with Down syndrome may reach developmental goals at a slower pace than other children the same age, they are typically able to develop skills throughout life.
Potentially Harmful Nature of Depakote
According to FDA documentation concerning Depakote, there have been reports of developmental delay and autism among infants whose mothers took Depakote while pregnant. The FDA also recently issued a safety advisory warning patients and healthcare professionals about the increased risk of severe birth defects among infants exposed to Depakote in utero. The notice included neural tube birth defects (malformations of the brain and spinal cord), craniofacial defects (abnormally formed face and skull), and cardiovascular malformations (defects of the heart and blood vessels). A study published in the New England Journal of Medicine in 2009 indicated that infants exposed to Depakote in utero had significantly lower IQ scores than infants exposed to other anticonvulsant medications.
The journal Neurology published a 2008 study which identified a potential connection between the use of Depakote and autism. The study involved 632 children, nearly half of which were born to women who took anticonvulsant drugs like Depakote during pregnancy, and researchers observed their development from the womb to childhood from 2000 to 2006. According to researchers, infants who were exposed to Depakote during pregnancy were seven times more likely to suffer from autism later in life, compared to infants who were not exposed to Depakote. Previously, in 2006, Neurology published a study which compared the adverse side effects of Depakote use with those of other anticonvulsant drugs. The report indicated that 20.3% of infants exposed to Depakote developed major birth defects, compared to 10.7% of infants exposed to Dilantin, 8.2% of infants exposed to Tegretol, and 1.0% of infants exposed to Lamictal.
Although new Depakote birth defect studies are still being conducted, the potentially harmful nature of the drug has been evident for several years. In fact, the New England Journal of Medicine published a study back in 2001 in which researchers determined that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero. This study in particular indicated that 20.6% of infants involved in the study who were exposed to one anticonvulsant drug like Depakote in utero were born with serious birth defects, compared to 28% of infants exposed to two or more anticonvulsants, and 8.5% of unexposed infants.
Depakote Lawsuits for Developmental Delay
Developmental delay is a serious birth defect which can cause a number of difficulties for an affected child throughout his life. Developmental delay in infants may be connected to the use of the anticonvulsant drug, Depakote, which has been labeled by the FDA as a pregnancy category D medication. Category D is reserved for drugs which positive human evidence has shown have the potential to cause significant harm to a fetus when taken during pregnancy. It may be dangerous to discontinue use of a prescription medication without medical consent, but with the help of your healthcare provider, you may be able to find a safer alternative to Depakote for treating your condition.
Besides the obvious physical and cognitive difficulties experienced by children with developmental delay, the victims’ families will also likely struggle with emotional and financial burdens as well. Some developmentally delayed children may require the attention of specialists, which can result in costly medical bills, for which the victim’s family should not be held responsible. The only way to protect your rights and the rights of your child is to contact an experienced Depakote attorney to discuss your legal options. You may have grounds to file a Depakote lawsuit or join a potential Depakote class action lawsuit in order to seek financial compensation for your injuries, medical expenses and pain and suffering. With the help of a qualified Depakote attorney, the families of potential Depakote birth defect victims can concentrate on caring for their child’s needs without having to concentrate on developing a birth defect case as well.
Contact a Depakote Attorney for Help
If you or a loved one has suffered from developmental delay which you believe to be associated with the use of Depakote, contact a Depakote attorney to discuss your legal options. Drug manufacturing companies are responsible for the safety of their medications and should be held liable for the potential side effects of their products. Unfortunately, some pharmaceutical companies use deceptive practices in order to avoid negative consequences, including intentionally withholding information concerning the harmful side effects of their medications. Fortunately, Depakote lawyers are well-versed in defective drug litigation and can help victims of alleged Depakote birth defects collect the compensation they deserve. A number of Depakote birth defect cases are currently being investigated across the country, and you may be entitled to reimbursement too, which you can collect by filing a Depakote lawsuit against Abbott Laboratories. Defective drug litigation can be a complicated process, but with the help of a knowledgeable Depakote lawyer, you can feel confident that your case is in good hands.