Video originally created by FDA -- posted by Lawsuit.com on July 14, 2008

FDA has issued an alert about increased mortality when using “atypical” antipsychotic drugs to treat behavioral disorders in elderly patients with dementia. The alert applies to drugs such as Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril (clozapine) and Geodon (ziprasidone). Symbyax (olanzapine and fluoxetine HCl), an antidepressant, is also covered by the advisory.These drugs are not approved for treating behavioral disorders in patients with dementia. In fact, they’re approved only for treating schizophrenia and mania. So this constitutes an unapproved, “off-label” use.The situation came to light when these drugs were being tested in clinical trials on elderly patients with dementia. Those treated with the drugs had a higher mortality rate than those receiving placebo. The causes of death were varied, but most of them appeared to be either cardiovascular or due to infection, such as pneumonia.FDA has asked the manufacturers of these drugs to add a boxed warning to the labeling describing the increased mortality risk. The labeling will also state that these drugs are not approved for treating behavioral symptoms in elderly patients with dementia.FDA is also considering adding a warning to the labeling of older antipsychotic medications, because limited data suggest that there may be a similar increase in mortality for these drugs.