Careful Consideration Needed When Prescribing Zyprexa or Risperdal for Alzheimer's-related Dementia
Elderly patients with Alzheimer's disease who are prescribed antipsychotic drugs such as Zyprexa and Risperdal have a higher risk of dying than patients who are given a placebo such as sugar pills according to a new meta-analysis of earlier drug-safety studies.
The new study appeared in the October 19, 2005 (Vol. 294 No. 15) edition of the Journal of the American Medical Association ("JAMA"). Lead investigator Lon S. Schneider, of the University of Southern California, said his meta-analysis of 15 trials involved about 5,000 patients. His study found that the risk of death rose from 2 percent to 3 percent for patients taking the antipsychotic drugs in clinical studies that lasted about 12 weeks. Schneider observed that most of the patient deaths came from cardiac problems or respiratory disorders. These findings lend support to the FDA's decision earlier this year to require new warnings on the package inserts, or labels, for Zyprexa and Risperdal.
Significantly, Zyprexa and Risperdal were approved by the FDA for treatment of psychoses in adults. These drugs, however, have not been specifically approved for use among elderly patients with dementia. As such, doctors are engaging in "off-label" prescribing when they have their dementia patients take these antipsychotic drugs, i.e., doctors prescribing Zyprexa or Risperdal for this group are relying on their clinical judgment.
Peter V. Rabins, a professor of psychiatry at Johns Hopkins University School of Medicine, reviewed the new meta-analysis by Schneider and wrote an editorial about it in the same October 2005 edition of JAMA in which the study is published. In an October 19, 2005 article by Washington Post reporter Shankar Vedantam, Dr. Rabins commented:
These medications are only modestly effective and have significant side effects associated with them. The drugs should not be used for trivial problems like difficulty sleeping at night and anxiety. Clinicians first need to really weigh the potential risks and benefits in deciding whether the potential harm from the symptoms is worth the risk.
About 4 million to 5 million Americans are diagnosed with Alzheimer's disease, a degenerative brain disorder. It is estimated that a third of those patients are given antipsychotic drugs.
Samuel E. Gandy is chairman of the medical and scientific advisory council of the Alzheimer's Association, a nonprofit research and advocacy group. He believes the new study by Schneider emphasizes the fact that careful consideration must be used when prescribing Zyprexa or Risperdal for dementia. "It should make physicians cautious when putting patients with dementia or any frail patient on medicines of this sort that are basically major tranquilizers," Gandy said, according the October 19 Washington Post article.
The consensus among experts in the field seemed to be that this new study should help doctors better weigh the risks and benefits of this off-label prescribing practice.
(Posted by: Tom Lamb)