Zyprexa-Related Strokes
The drug manufacturer Eli Lilly & Co. issued a warning in 2004 that its atypical antipsychotic drug Zyprexa may increase the risk of stroke and death in elderly patients when Zyprexa is used to treat aggression from dementia caused by Alzheimer’s disease.
Lilly issued the Zyprexa warning after a study of more than 1,600 elderly Zyprexa patients with various forms of dementia and Alzheimer’s disease revealed that risk of death was twice as high among those taking Zyprexa than among those taking a Zyprexa placebo. It should be added that there was a higher incidence of pneumothoracic conditions in these Zyprexa patients that may have led to their deaths. Another common factor in these Zyprexa patients was their use of short half-life benzodiazepines.
Zyprexa or olanzapine was approved by the FDA in 1996 for the treatment of schizophrenia and bipolar disorder. In more recent years, Zyprexa has been prescribed for off-label use in the treatment of aggression from dementia. Eli Lilly’s aggressive pursuit of this off-label use for Zyprexa has landed the company in trouble.
Given the significant dangers posed by Zyprexa to the elderly, the FDA requested that Eli Lilly & Co. add a black box warning in 2005, indicating that Zyprexa is not indicated for treatment of dementia in the elderly. This warning against off-label prescription was subsequently expanded to include all atypical antipsychotics.