FDA and Experts: Antipsychotics Dangerous to Elderly

A series of studies has been published recently that shows that the use of antipsychotic drugs in vulnerable seniors is not to their benefit and actually hastens their demise.

The April 2007 issue of the Archives of Internal Medicine contains a study that analyzed the use of such drugs in elderly in nursing homes in Ontario, Canada.  Researchers with the Institute for Clinical Evaluative Sciences found that these homes have largely been using the drugs to sedate patients not for any clinical indication that would require the use of antipsychotics (these drugs are not FDA-approved for use in the elderly).  Lead researcher Dr.  Paula Rochon, a geriatrician, stated that “…people are using them for the wrong reasons.  They certainly are not drugs that should be used to deal with sleep problems or people wandering.” 1

Ontario's Minister of Health has stated that there is a bill before the legislature to address this form of “chemical restraint.” 2

In late March, British researchers reported that Alzheimer's patients prescribed antipsychotic drugs as sedatives are dying earlier because of the drugs.  A five-year investigation found that the drugs, when given to Alzheimer's sufferers, caused a significant increase in death rate, with patients on antipsychotics dying an average six months earlier than those given placebo.  Lead researcher Clive Ballard of King's College London said the latest study showed there was no benefit in giving neuroleptics to people with mild Alzheimer's. 3

An October 2006 study in the New England Journal of Medicine found that these drugs were no more effective than placebo for easing agitation and aggression in people with Alzheimer's and that they carried serious side effects, including confusion, sleepiness and Parkinson's disease-like symptoms.  About 4.5 million Americans suffer from the progressive dementia of Alzheimer's disease, and most patients with the advanced disease exhibit agitation or delusions at some point.  About a third of the estimated 2.5 million Medicare beneficiaries in nursing homes in the United States have been given these drugs. 4

These drugs are used not only in nursing homes and long-term care facilities, but also in geriatric psychiatric wards.  That anyone—including psychiatrists—continues to give these drugs to elderly Americans flouts a federal warning: On April 11, 2005 the U.S.  Food and Drug Administration advised physicians not to give elderly patients with dementia antipsychotic drugs.  The drugs named in the warning were Abilify, Zyprexa, Seroquel, Risperdal, Clozaril and Geodon.  All are associated with a higher death rate when given to elderly patients with dementia for behavioral problems.  Manufacturers of these drugs were ordered to add a boxed warning to their labels describing the risk and noting the drugs are not approved for treatment of behavioral symptoms in elderly patients with dementia. 5

It can be seen that these drugs are widely understood to be harmful to senior citizens.  Perhaps you or your firm have been contacted by the bereaved survivors of seniors who were prescribed this class of drug.  If so, you should be aware of this information as it could be something upon which to base a viable cause of action.

1 Lindgren, April, “Antipsychotic drugs over-prescribed in Ontario nursing homes,” CanWest Media Services, 10 Apr 2007

2 “Ont. health minister says new bill addresses anti-psychotic drugs in nursing homes,” Canadian Press, 11 Apr 2007

3 “Dementia patients dying early on sedatives: study,” Reuters, 29 Mar 2007

4 Carey, Benedict, “Alzheimer's Drugs Offer No Help, Study Finds,” New York Times, 16 Oct 2006

5 “Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances,” FDA Public Health Advisory, 11 Apr 2005

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