Zyprexa Warning Issued
The FDA has ordered a new warning to be put on Zyprexa, as well as other antipsychotic drugs like Symbyax, Seroquel, Risperdal, Clozaril, Geodon and Abilify.
The FDA is alerting physicians to a higher death rate when the medicines are prescribed for atypical use of treating dementia in elderly patients. The agency said it has asked the Zyprexa manufacturer, as well as the other affected drugmakers, to add boxed warnings to the labels describing the increased risks and noting the drugs are not approved to treat symptoms of dementia in the elderly.
According to the FDA, the death rate for elderly patients on the medication were 1.6 to 1.7 times greater than those on a placebo, and most of the deaths were either heart related or from infections. Since the agency believes, after reviewing 17 studies of four drugs in the class, that the health risks are a class effect, it has ordered Zyprexa and other antipsychotic drug manufacturers to add the new warning labels.
An Eli Lilly spokeswoman said the Zyprexa label has carried a warning with data on increased mortality risk in elderly dementia patients since May 2004. In addition, the spokeswoman said the company notified physicians of the Zyprexa risk since January 2004.
Tags: abilify, clorazil, geodon, risperdal, seroquel, symbyax, zyprexa
