Large lawsuit about mis-labeling the drug. Depakote, an anti-seizure and mood-stabilizing drug, was first approved by the FDA in 1983 to treat certain seizures in adults and children older than 10. Since then, the drug has been approved to treat other types of seizures, manic episodes of bipolar disorder and for the prevention of migraine headaches.
The Justice Department said in a release that the company illegally marketed Depakote for uses including for treatment of schizophrenia, agitated dementia and autism.
Though doctors can prescribe drugs "off-label," as the practice is known, companies are prohibited from marketing them to treat conditions that are not approved by the FDA.
Abbott said it had been under investigation for four years in connection with the sale and promotion of Depakote stretching back to 1998.
The investigations led by the federal government and states' attorneys general were based partly on whistle-blower lawsuits filed in federal courts in Illinois, Virginia and the District of Columbia that accused Abbott of illegally promoting Depakote. Those suits also alleged that the company gave doctors and pharmacists illegal kickbacks to talk about off-label uses of the drug to boost sales.
The first suit, filed in 2007 by former Abbott saleswoman Meredith McCoyd, accused the drugmaker of encouraging her and other salespeople to promote the drug in nursing homes and public mental health centers, where most patients were covered by federal health care programs, including Medicaid.
The Justice Department intervened in those suits to determine whether the company's marketing of the drug violated civil and criminal laws.
In a release, the Justice Department said Abbott admitted that from 1998 to 2006, it "maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use."
From 2001 to 2006, it said, the company marketed the drug for use in combination with antipsychotic drugs to treat schizophrenia, though its own clinical trials showed Depakote provided no benefit.
Nora, thanks for the information. DH was one of the patients in a psych hospital that the psychiatrist prescribed Depakote in combo with seroquel to control agitation (incessant pacing) and aggitation. DH had a bad reaction- high liver enzymes so they stopped the depakote and substituted neurontin. It's a crap shoot.
Steve was in a clinical trial testing Depakote for use in dementia patients. I believe the results of that trial were that it showed no benefit in treating dementia, as well. He had a bad gastro effect from the drug (apparently, he didn't receive the placebo) and had to drop out of the study after a week.