Abbott slapped with more fines for illegal promotion of Depakote
Abbott Laboratories was fined more than $700 million for illegally promoting its anti-seizure drug Depakote for unapproved uses. The drug company was ordered to pay a fine of $500 million, forfeit another $198.5 million, and pay $1.5 million to the Virginia Medicaid Fraud Control Unit. The drug company will also be subject to a five-year probation. The fines are in addition to the $1.6 billion the company agreed to pay to settle criminal and civil claims that arose from the unlawful promotion of Depakote.
Abbott admitted that from January 1998 to December 2006 it marketed Depakote as a treatment for agitated dementia. The drug company said it trained its sales staff to push Depakote for the unapproved use because the drug was not subject to federal regulations designed to prevent the use of unnecessary medications in nursing homes.
Abbott also said that from January 2002 to December 2006, it pushed sales of Depakote as a treatment for schizophrenia - another unapproved use - despite clinical trials that showed the drug was no more effective than antipsychotic drugs in treating the condition.
Doctors can prescribe medications for conditions that are not indicated by the drug’s safety label. However, drug companies are forbidden to market products for unapproved uses.
Prescribing medications for off-label uses also puts patients at unnecessary risk for side effects. For example, use of Depakote during pregnancy has been found to be dangerous to developing fetuses. One study even suggested that Depakote use during pregnancy increased the chances by tenfold of a baby being born with spina bifida compared to other anti-seizure drugs.
Abbott has also entered into a civil settlement agreement to pay $800 million to resolve claims that its illegal activities targeting the elderly caused false claims to be submitted to government health care programs.
- Abbott to pay $1.5 billion for marketing Depakote for unapproved uses
- Abbott to pay $1.5 billion for illegally promoting Depakote, thanks to whistleblower lawsuits
- Off label use of Depakote unnecessarily exposed users to side effects
- Whistleblower lawsuit reveals Abbott may have pushed cholesterol drug for unapproved uses
- Lawsuit claims Depakote during pregnancy caused serious birth defect