The anticonvulsant valproate sodium—sold primarily under the brand names Depakene and Depacon—has been identified as a potential cause of disfiguring birth defects.
What Is Depakene? When Is It Prescribed?
Valproate sodium is the sodium salt of valproic acid, which pharmaceutical companies also often sell for the same therapeutic purposes. Valproate sodium is the commonly used generic name for the brand name drugs Depakene and Depacon, manufactured by the U.S. pharmaceutical company Abbott Laboratories. The U.S. Food and Drug Administration (FDA) has approved these drugs for the treatment of manic episodes in those with bipolar disorder, migraines, and epilepsy. The FDA approved Depakene in February 1978; Abbott markets it in an oral syrup containing 250 mg/mL of valproate per dose. In December 1996, the FDA approved Abbott’s Depacon in the form of a 100 mg/mL valproate injection.
Scientists are unsure of Depakene’s mechanism of action. One theory is that it is a GABA transaminase inhibitor. The GABA system is the primary neurotransmitter that regulates neuron activity in the nervous system, and by inhibiting it, valproate reduces convulsions caused by epilepsy.
In February 2011, the Department of Justice intervened in a whistleblower lawsuit brought by three current and former Abbott Laboratories employees who disclosed that Abbott was marketing a valproate-related drug, Depakote (valproic acid), for treating Alzheimer’s disease and dementia. According to the Chicago Tribune, in October 2011, Abbott agreed to settle with the Department of Justice and 24 state governments for $1.3 billion. Subsequently, shareholders filed a derivative lawsuit.
Depakene Side Effects Include Birth Defects and Suicide
Since at least 2006, the FDA has required that valproate manufacturers include a black box warning—the agency’s most serious kind—on the product’s label stating that it has the potential to cause birth defects. This warning exists in part due to a study published in the medical journal, Neurology in August 2006. the study found that birth defects occurred 20.3% of the time when women were on valproate, compared to 1.0%-10.7% of the time when women used other antiepileptic drugs. In late 2009, the FDA released a Drug Safety Communication reminding the public and healthcare professionals of Depakene birth defect risks, which include:
- craniofacial defects (cleft lip and palate)
- neural tube defects (spina bifida)
- cognitive impairments (measured in low IQ)
- abnormal skull formation
- malformed limbs
- extra fingers or toes
- urinary problems
- septal defects in the heart
The FDA based its Drug Safety Communication on data collected from the North American Antiepileptic Drug (NAAED) pregnancy registry. The data showed that, when mothers did not use any antiepileptics, one in 1,500 babies was born with congenital neural tube defects. However, the likelihood of birth defects forming in children born to women who used valproate was one in 20. The NAAED data also showed that valproate was four times more likely to cause neural tube defects than other antiepileptics.
In June 2011, the FDA issued another Drug Safety Communication, warning the public and professionals that children born to valproate users scored lower on cognitive tests than children born to mothers who used other antiepileptic drugs such as lamotrigine, carbamazapine, and phenytoin. The FDA arrived at this conclusion after evaluating multiple epidemiological studies, including one conducted on three-year-olds in both the United States and the United Kingdom who took the Differential Ability Scale, which is administered in place of IQ tests to children too young to take them.
In January 2008, the FDA issued a Drug Safety Communication concerning all antiepileptic drugs’ tendency to cause suicidal ideation and behaviors in users. By late 2008, the FDA required that antiepileptic manufacturers include such warnings on their drug labels. The warning is based on a meta-study of 199 placebo-controlled clinical trials that discovered that antiepileptic users experienced suicidal thoughts at double the rate of the placebo population (0.43% vs. 0.24%).
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that getting satisfaction from the company that harmed you shouldn’t be just more hardship. That’s why we do everything we can to streamline the process of helping victims get the compensation they deserve.
If you have taken Depakene and believe it harmed you or your child, contact RLG today.