June 16, 2008

Older Antipsychotics Get Black Box Warning For Dementia

I was just on a conference call with FDA officials wherein the agency announced it was adding a black box warning to first generation--aka, typical--antipsychotics concerning their use in elderly patients with dementia. The label will alert clinicians to "increased deaths in elderly patients with dementia," said Thomas Laughren, head of the FDA's psychopharmacological division.

Previously, there has not been a black box warning on the older drugs such as Thorazine, Haldol and Mellaril, but recent observational studies out of Canada have established there that is a risk of "excess mortality" in elderly patients given these drugs, Laughren said. A somewhat similar black box warning has been in place on atypical antipsychotics relative to their use in the elderly since 2005. Laughren said the FDA does not know what the mechanism is that is causing the deaths and that causes are difficult to identify in patients whose average age is late-80s and who have multiple, ongoing health issues. The deaths are mostly related to cardiac incidents and pneumonia.

The risk of death associated with the older antipsychotics was 4.5 percent in one study versus 2.6 percent in patients on a placebo. Other studies indicate that risk of death in dementia cases is slightly higher with atypical antipsychotics. You can read the FDA's press release here.

I've previously covered issues around antipsychotic use and dementia here.

Posted by Philip Dawdy at June 16, 2008 01:09 PM
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Comments

This is good news, (but the warning needs to be expanded)and it makes me wonder about all of the people I've seen/known who use/used Haldol--what happens to the people who are older and approach a point where, age becomes a factor? go off of it? then what?

I feel the black box warning should be broader--but then of course the FDA only has data for the elderly,(to base a black box warning on these drugs) which is just plain wrong.

Posted by: Stephany at June 16, 2008 02:32 PM

I wonder why the FDA is puzzled as to the reason for people with dementia dying more often on antipsychotics than those on a placebo.

We know this is true for people of all ages - not just for older people or older people with dementia.

We could look at the risk of adverse reactions for antipsychotics - use a little common sense here- such as neuroleptic malignant syndrome, tacycardia, diabetes, troubles with swallowing, eating and breathing, etc. The list goes on---

Go to http://www.ssristories.com/show.php?item=2608 and read about the 12 soldiers out east - young soldiers in their 20's just returned from Iraq - all of whom have died in their sleep from a combo of SSRI, atypical antipsychotic & a benzo given for a diagnosis of PTSD. I have a feeling that the doses are really high or the confusion caused by the drugs is making these soldiers forget when they took their last dose and they are double dosing, etc. BUT the saddest part of all this is that these statistics are coming from the FATHER of one of the young men who died in this manner. Why, pray tell me, are the stats coming from the father of a victim. Don't we have statiticians in the military anymore or are they not allowed to reveal figures.

While we are at it, why does a grandmother, yes a grandmother, have to hunt up and post tragic antidepressant cases - now at 2,384 - for www.SSRIstories.com

Where is the scientific/medical/military/industrial complex and their epidemiologists? What a question!!

Posted by: Rosie C. at June 16, 2008 07:04 PM

Re: the unknown mechanism causing these deaths, the connection between neuroleptics and pneumonia or cardiac complications was flagged decades ago by Dr. Frederick Zugibe, former Medical Examiner of Rockland County. His news was not well received:

http://e-forensicmedicine.net/drugs.htm

...............

"The Medical Examiner's Office opined that based upon autopsy findings and a statistical review, it appeared that a contributing factor in a large percentage of aspiration deaths at the two state psychiatric facilities located in Rockland County was the use of psychotropic and/or sedative drugs. This opinion was met by relentless and inordinate political pressures resulting in a barrage of formal hearings, distortions, character assassination, credibility undermining, harassment, and false accusations. Nevertheless, the Medical Examiner fervently stood by its findings and after nearly a year and a half, the Office was vindicated."

Zugibe's chapter "Sudden Death Related to the Use of Psychotropic Drugs" (in Legal Medicine, edited by Cyril Wecht and published in 1980) goes into details -- including how suppression of the cough reflex, a feature of neuroleptics, can lead to aspiration of food particles, pneumonia and death.

Posted by: Laura Ziegler at June 16, 2008 07:41 PM
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