Depakote and Autism
Depakote is an anticonvulsant medication manufactured by Abbott Laboratories which was originally approved by the FDA in 1983 for the treatment of epileptic seizures. In 1995, the FDA added an indication for the treatment of the manic phase of bipolar disorder, and less than a year later, for the prevention of migraine headaches. Depakote has been on the market for nearly three decades and has become one of the most commonly prescribed anticonvulsant drugs on the market, estimated to have treated 2.4 million people in the United States alone since its inception.
Unfortunately, many people who took Depakote in the past have come forward with concerns about the safety of the drug after experiencing major adverse side effects, particularly women who took the drug while pregnant and gave birth to infants with severe birth defects. In support of these findings, several studies have been conducted in recent years which have identified a potential connection between Depakote use during pregnancy and disruptions in fetal development. Among the birth defects allegedly associated with Depakote use is autism.
Autism is a type of developmental disorder which inhibits the normal development of social and communication skills in the brain. Some of the symptoms commonly associated with autism include difficulties in social interactions, pretend play, and verbal and nonverbal communication. In most cases involving autistic children, parents suspect that something is wrong by the time the child is 18 months old and seek help by the time the child reaches two years old.
Symptoms of Autism
The most common issues experienced by children with autism involve issues with communication, social interaction, response to sensory information, play, and behavior. Specific problems include:
- Failure to start or maintain a conversation
- Slow or nonexistent language development
- Repeating words or memorized passages
- Being withdrawn
- Showing a lack of empathy
- Preferring to spend time alone
- Treating others like they are objects
- Finding normal noises painful to the ears
- Rubbing surfaces or licking objects
- Withdrawing from physical contact because of over-stimulation
- Preferring solitary play
- Showing little imaginative play
- Failure to imitate the actions of others
- Experiencing excessive temper tantrums
- Having an extremely short attention span
- Having very narrow interests
- Showing aggression towards others
Autism Treatment and Prognosis
Children with autism who receive a prompt diagnosis can benefit greatly from an intensive treatment program. Many of these programs are geared towards building on the child’s interests in a highly structured environment, involving constructive activities and visual aids. Some available therapy options include occupational therapy, speech and language therapy, and physical therapy. Because treatment is most effective when it is tailored to the child’s specific needs, the best treatment option is often a combination of various techniques.
Although autism is still a challenge for affected children and their families, the prognosis today is much more positive than it was in the past. However, in many cases, children with autism will experience some symptoms throughout their lives, although many can be improved with adequate treatment. Unfortunately, autism is sometimes associated with additional complications like mental retardation, tuberous sclerosis, and seizures.
Depakote and Birth Defect Studies
According to a study published in the journal Neurology in 2008, there may be a connection between the use of Depakote during pregnancy and the development of autism in infants exposed to the drug in utero. The study involved 632 children, nearly half of which were exposed to anticonvulsant drugs like Depakote in utero, who were studied from the womb to birth and into childhood between 2000 and 2006. According to researchers, infants who were exposed to sodium valproate (Depakote) in utero were seven times more likely to develop autism later in life, compared to infants who were not exposed to any anticonvulsant drugs during pregnancy.
Other anticonvulsant drug and Depakote studies have found similar results. In fact, the FDA recently issued a safety announcement regarding the increased risk of birth defects among infants exposed to Depakote during pregnancy. The notice included neural tube birth defects (malformations of the brain and spinal cord), craniofacial birth defects (defects of the face and skull), and cardiovascular malformations (abnormally formed heart and blood vessels). In 2001, the New England Journal of Medicine published a study in which researchers identified anticonvulsant drugs as one of the most common causes of potential harm to a human fetus. More specifically, 20.6% of infants exposed to one anticonvulsant drug like Depakote during pregnancy developed major birth defects, compared to 28% of infants exposed to two or more anticonvulsants, and only 8.5% of unexposed infants.
Another study published in Neurology in 2006 determined that the prevalence of serious birth defects was significantly higher among infants exposed to valproate (Depakote) during pregnancy, compared to infants exposed to other anticonvulsant drugs. According to researchers, 20.3% of infants involved in the study whos mothers took Depakote while pregnant were born with major malformations, compared to 10.7% of infants exposed to Dilantin, 8.2% of infants exposed to Tegretol, and 1.0% of infants exposed to Lamictal.
Depakote Use During Pregnancy
The FDA has labeled Depakote 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 Depakote to pregnant women unless all other available treatment options have failed or the possible benefits of the treatment justify the potential risks to the fetus. If you are currently taking Depakote and you are pregnant or planning to become pregnant, consult your physician as soon as possible. It may be unsafe to discontinue use of a prescription medication without medical consent, as this may cause further harm. However, with the help of your doctor, you may be able to find a safer way to treat your medical condition.
Contact a Depakote Attorney for Help
Autism is a condition which, according to the U.S. Centers for Disease Control and Prevention, is more common than previously thought. Children with autism will likely struggle with a number of difficulties throughout childhood and adulthood which will affect several aspects of their lives. If you or a loved one has suffered from autism which you believe to be associated with the use of the anticonvulsant drug, Depakote, contact a Depakote attorney to discuss your legal options. You may have grounds to file a Depakote lawsuit or join a potential Depakote class action lawsuit against Abbott Laboratories in order to seek financial compensation for your injuries and medical expenses, as well as the pain and suffering endured by you and your family.
Victims of adverse side effects caused by a dangerous drug are not at fault. Drug manufacturing companies are responsible for the safety of their medications even after they are approved by the FDA and enter the market. Drug companies are also responsible for alerting the public of any potential dangers associated with their medications, which they often fail to do. This puts consumers at risk of suffering significant injury or even death, which could have been avoided. Defective drug lawsuits can be a complication process, but with the help of an experienced Depakote lawyer, victims of alleged Depakote birth defects can feel confident that their case is in good hands.