It is unclear what caused the deaths of two patients injected with the anti-psychotic medication Zyprexa, but the U.S. Food and Drug Administration is investigating. According to the FDA, the two died a few days after being injected with Zyprexa Relprevv.

The drug’s warning label contains information about delirium sedation syndrome that can occur but reportedly no deaths have been noted in any clinical trials. MarketWatch reports the individuals received an appropriate dose of Zyprexa, not an excessive dose.

InjectionWe should not be surprised that drugmaker Eli Lilly & Co. denied the deaths were related to the drug and is not aware of any post-injection delirium or sedation syndrome that occurred.

Zyprexa is a blockbuster drug for Lilly generating about $60 million in sales last year. It is used to treat schizophrenia and a specific type of bipolar disorder.

However Lilly and its sales reps also urged the drug be used off-label to treat nursing home residents to treat behavioral symptoms such as Alzheimer’s disease, dementia, agitation and depression. Zyprexa was also prescribed off-label for use in children who acted out.

The drug has always been controversial. Among elderly patients, many experienced heart failure and pneumonia. Some children gained weight and developed diabetes. That didn’t stop Lilly from launching an advertising campaign that the FDA called false and misleading back in November of 1996.

Four years later, Eli Lilly got even more aggressive with its “Viva Zyprexa” campaign to urge the everyday use of Zyprexa. Marketing tactics included lectures urging off-label use with sales representatives in the audience posing as curious patients. Lilly created a film, “The Myth of Diabetes,” to minimize the Zyprexa weight gain-diabetes connection.

The company eventually pled guilty to one misdemeanor violation of the Food, Drug, and Cosmetic Act and with it agreed to pay an $800 million civil fine and over $600 million in criminal penalties. That was shared with the six whistleblowers within the company who told tales out of school.

As is almost always the case, the drugmaker is ordered to enter into a corporate integrity agreement with the federal government that it won’t do the misdeed again. That is, until the next time.