Chicago, ILAbbott Laboratories, maker of Depakote faces a whistleblower lawsuit alleging the company illegally marketed its epilepsy medication.
According to the Chicago Tribune (11/13/11), a whistleblower lawsuit was filed in 2010 by Thomas Spetter Jr, who alleges he was told to market Depakote, an epilepsy drug, for off-label uses. Specifically, Spetter says he was told to market Depakote as a treatment for agitation associated with dementia, a use of Depakote that was not approved by the US Food and Drug Administration (FDA).
Off-label use of a drug refers to uses that are not approved by the FDA. It is not illegal for doctors to prescribe a medication for off-label use, and in fact it happens frequently. It is, however, illegal for companies to market their medications for off-label use. This is because drugs have not been adequately tested for safety or effectiveness when used for unapproved purposes.
Now, the US Department of Justice is involved in the Depakote lawsuit, investigating whether or not Abbott illegally marketed Depakote. In October 2011, Abbott reportedly announced it set aside $1.5 billion to settle allegations about its medication. A spokesperson told the Tribune that discussions are ongoing, but did not elaborate.
Allegations against Abbott reportedly include that the company encouraged the off-label marketing of Depakote and gave illegal kickbacks to doctors who were willing to talk about off-label uses of the drug. Although Depakote is approved to treat seizures and prevent migraine headaches, it is not approved to treat dementia. Sales reps were allegedly trained to teach doctors to miscode a patient's illness so Depakote could be prescribed without alerting regulators.
Some studies have linked the use of Dapkote while pregnant to serious birth defects in children exposed to the medication prior to birth. Among the reported Depakote birth defects is spina bifida, a birth defect in which the spinal cord and backbone do not develop properly. According to a study published in the New England Journal of Medicine (09/10/10), among infants exposed to valproic acid (the generic name for Depakote) during the first trimester, the risk of spina bifida was 12 to 16 times as high as infants not exposed to the medication.
Furthermore, the risks of atrial septal defect, cleft palate, hypospadias, polydactyly and craniosynostosis were two to seven times higher than the risk of infants who were not exposed. Researchers also reportedly found an increased risk of limb defects in infants exposed to valproic acid.
Researchers found that exposure to valproic acid during the first trimester was associated with an increased risk of six birth defects when compared with infants not exposed to antiepileptic medications. They further found that exposure to valproic acid was associated with an increased risk of birth defects even when compared with other antiepileptic medications, leading them to support recommendations against the use of valproic acid, where possible, in pregnant women.
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