The anticonvulsant valproic acid—sold under the brand name Depakene in capsule form, and in extended release capsules as Stavzor—might have caused your child to suffer disfiguring birth defects.
What Is Stavzor and What Is Prescribed For?
Valproic acid is the official name for the chemical 2-propylvaleric acid. It is a component of many drugs, including valproate sodium and divalproex sodium, and it is sold generically by numerous manufacturers. The most common formulation is Depakene capsules sold by Abbott Laboratories containing 250 mg valproic acid. The syrup form of Depakene is technically valproate sodium but many scientists ignore the distinction.
The U.S. Food and Drug Administration (FDA) approved Depakene in 1978. The most recent formulation is the delayed release version, Stavzor, which is manufactured by Banner Pharmacaps, Inc., a subsidiary of the Dutch company, Vion Food Group NV. The FDA approved Stavzor in 2008 in the form of oral capsules ranging from 125 mg to 500 mg valproic acid. B.S. Burton discovered valproic acid due to its similarties to valeric acid found in the plant valerian. It was not until 1962 that French researchers discovered its anticonvulsant properties. The French government approved it in 1967, and since then it has become the most used anticonvulsant worldwide.
Scientists are unsure of valproic acid’s mechanism of action, though they know it dissociates into the valproate ion in the gastrointestinal tract. 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 U.S. Department of Justice intervened in a whistleblower lawsuit brought by three current and former Abbott Laboratories employees who disclosed that Abbott was marketing a drug related to Depakene, Depakote (divalproex sodium), 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. The Rottenstein Law Group does not know if the Department of Justice also sued Banner Pharmacaps.
Stavzor Side Effects Include Birth Defects and Suicide
Since at least 2006, the FDA has mandated valproic acid manufacturers include a black box warning—the agency’s most serious kind—on the product’s label due to its possibility of causing birth defects in women. This warning exists in part due to a study published in the medical journal, Neurology, in August 2006, finding that valproic acid caused birth defects in 20.3% of women vs. 1.0%-10.7% in women using other antiepileptic drugs. In late 2009, the FDA released a Drug Safety Communication reminding the public and healthcare professionals of these valproic acid 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; and
- Septal defects (heart problems).
The FDA based its Drug Safety Communication on data collected from the North American Antiepileptic Drug (NAAED) pregnancy registry. The data showed that one in 1,500 babies born to women who did not use any antiepileptics had congenital neural tube defects. By contrast, the likelihood of birth defects forming in children born to women who used valproic acid is one in 20. The NAAED data also showed that valproic acid 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 Stavzor 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 substitutes for IQ tests in 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, it required that antiepileptic manufacturers include such warnings in 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 Stavzor 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 Stavzor lawyers at the Rottenstein Law Group believe that getting satisfaction shouldn’t be just more hardship. That’s why we do everything we can to streamline the process, and we will file a Stavzor lawsuit on your behalf if necessary. RLG will also keep you up to date on any Stavzor class action lawsuits, FDA Stavzor warnings, and Stavzor FDA recall announcements. If you have taken Stavzor and experienced adverse side effects, contact RLG today.