The maker of the anti-schizophrenia drug Zyprexa allegedly marketed the drug for "off-label" use in patients with dementia, despite lacking evidence that it worked for that purpose, the Bloomberg news service reported Friday, citing internal company documents.
Some four years after Eli Lilly & Co. told the U.S. Food and Drug Administration that its studies found no evidence that Zyprexa helped elderly dementia patients, in 1999 the company began pitching the drug for use in such patients, Bloomberg reported.
In fact, the studies found that elderly people with Alzheimer's disease and other forms of dementia who took Zyprexa faced a "significantly greater" risk of death than those who didn't take the drug, according to the news service.
In 2005, the FDA began requiring warning labels on Zyprexa and similar "antipsychotics," noting that the drugs increased the risk of death among elderly dementia patients, Bloomberg said.
Lilly's documents have been released as part of lawsuits against the drug maker by insurers and pension plans, according to Bloomberg. The plaintiffs are seeking up to $6.8 billion in damages, alleging the company ignored the drug's health risks and marketed Zyprexa for off-label use to increase sales.
Lilly pleaded guilty earlier this year to a federal misdemeanor charge of pitching the drug for off-label use for seniors with dementia. Lilly conceded illegally marketing the drug from September 1999 through March 2001, but has denied claims beyond that date. A company spokeswoman accused those bringing the lawsuits of "releasing one-sided cherry picked documents obtained in discovery to selected news media in an effort to try their case in the media," Bloomberg reported.