May 27, 2008

Study: Antipsychotics Killing, Injuring Elderly With Dementia At Shocking Rate

I really don't know what other headline to put on this Archives of Internal Medicine paper that came out yesterday from researchers showing that patients with dementia face a risk of death or other serious event at more than 3 times the rate of other elderly with dementia who don't get an antipsychotic. Given that recent studies (such as CATIE or this British study from January or this Dutch study from March) have found that giving antipsychotics to such patients is less effective than placebo, you've got to wonder what the rationale continues to be for pressing these meds on the elderly. I can kind of understand this in select cases, but as a standard of practice I cannot understand this medical approach. It's not playing out well clinically at all.

Of course, allegations of off-label marketing of second generation antipsychotics for use in the elderly is at the heart of several states' lawsuits against makers of these drugs. Strangely, that bit of context and the CATIE results didn't find their way into this piece in the Washington Post by Health Day News, which I guess is becoming part of the paper's health reporting team, itself the reported victim of a major shakeup coming out of the paper's recent buyouts cum layoffs.

Anyway, the reporter offered this:

"However, the problems underlying the need for such medications, behavioral problems such as aggression and agitation, are very real, and the alternatives to antipsychotics are limited, the researchers added.

"'A misreading of the findings would be we don't need to do something for these nursing home residents,' said study author Dr. Gary J. Kennedy, head of geriatric psychiatry for Montefiore Medical Center in New York City.

"Many experts feel behavioral interventions should be tried first and antipsychotics used as a last resort, 'when the behavior or the psychiatric symptoms are really out of control and causing complete distress not only for the person suffering from Alzheimer's, but for caregivers all around them,' said Maria Carrillo, director of medical and scientific affairs at the Alzheimer's Association in Chicago. 'It's important to work these things out with the physician and, of course, do follow-up very closely together, so you can make sure these antipsychotics are having the effect you want and, if not, discontinue them immediately.'"

The study was broken down into two main groups--those living in the community and those in nursing homes--and three subgroups--those getting no antipsychotics, those getting second generation antipsychotics and those getting first generation antipsychotics. The study was based upon the medical records of about 43,000 patients with dementia between 1997 and 2004.

Dementia patients who lived in the community and got a second generation antipsychotic were 3.2 times more likely to die or be hospitalized than patients who got no antipsychotic. With a first generation antipsychotic the rate jumped to 3.8 times. And the deaths and hospitalizations were occurring within 30 days of getting the drugs. That's just shocking to me.

As for nursing home patients with dementia, the rates of deaths or serious problems were 1.9 times for the newer drugs and 2.4 times for the older ones.

These findings simply amaze me. A reader who shot me an email last night posed an interesting irony:

"I can't help wondering how parents who strongly advocate for their children (including adult children) to take antipsychotics, view second generation anti-psychotics as miracle drugs, use extortion to achieve medication compliance, or insist on injectable anti-psychotics would feel if they realized that they face a future which might involve these very medications."

Anyone care to take a crack at that?

Separately, what with continued scientific evidence of health consequences for elderly patients getting antipsychotics, you've got to wonder what the health consequences are for people diagnosed with schizophrenia and bipolar disorder and why there is not more of a hew and cry on that front. We already know that antipsychotic use shortens the lifespan of people with schizophrenia. I don't know of similar evidence for people with bipolar disorder, but I'd be surprised if the evidence were appreciably different. What's interesting is that dementia patients generally get these drugs at lower doses than schizophrenics and bipolars. All of this also makes you wonder what outcomes will be like for patients who will get Seroquel for depression under its forthcoming FDA approval.

Or am I wondering too much here?

Posted by Philip Dawdy at May 27, 2008 12:05 AM
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Comments

Maybe nursing homes continue to use these drugs because it makes their lives easier. Their patients are easier to manage and they die faster. They make money on turnover.

Posted by: mark at May 27, 2008 12:33 AM

I've always asked why there was a dementia/elderly warning for use for these drugs and wondered what the difference was, whether a person is 25, 55 or 85; the drug would in my opinion affect anyone, and it reminded me of the black box warning for SSRI's having that age 25 cut off---yet ppl over 25 clearly have adverse effects!

So in my opinion the drugs should be treated with a black box warning (the FDA says they only have data on "demented elderly" to do that. ((wow that warning really worked!))

As far as the email comment re: parents with adult age kids? I'm one of those who has an adult age kid who does take an antipsychotic and it scares the hell outta me. Period.

Due to the fact that their IS a black box warning for elderly patients with dementia on the drugs I never can figure out why they are so readily dispensed without it being a crime in nursing homes. It appears the drugs are probably being used as a standard typical medical model of treatment, and used too casually.

Posted by: Stephany at May 27, 2008 04:48 AM

I agree there should be a black box for everyone taking these drugs: Funny how the FDA rushed to place a warning for off label use for those with dementia only, but no one else. As to the morality of this use, a colleague of mine said her family knew of the risk, and basically felt relief when the inevitable happened to their mother. She said, under the circumstances, she bet I would have felt the same way about an elder parent. Strikes me as euthanasia, but with no Dr. Kevorkian arrests.

Posted by: Sorrowful at May 27, 2008 11:33 AM

Well, the study of shortened lifespans among those with schizophrenia mentions such causes as suicide, lack of self-care for people with diabetes, etc. Though there may not be a similar study for those with bipolar disorder, I know of three sterling young men who died from Zyprexa. Two were in their twenties, one in his thirties. Causes of death: profound hyperglycemia; pancreatitis. I wonder why the FDA or Pharma hasn't done a study on this.

Posted by: Sorrowful at May 27, 2008 11:43 AM

I have seen the face of long-term poly-pharmacy in the person of a beloved aunt. She was first treated for depression after the death of her mother. This was in the 60's. The label was manic depression. I am uncertain of the medications used initially, but I know treatment included multiple rounds of ECT. I never remember her behavior being extreme or bizarre. She was intelligent, athletic, caring, generous, deeply religious. She held down responsible positions as office administrator. At some point she was put on lithium. She liked being on lithium for approximately seven years, until she developed resting hand tremors. She asked her psychiatrist if she could go off it, he said yes, and she went off lithium "cold turkey". She was soon found one evening confused and wandering the street near her home in her nightclothes. She was rushed to a nearby hospital. I don't know what drugs were administered on admission (I now can guess) and by the time I visited her she was curled up in the fetal position, having frightening auditory hallucinations, and totally disconnected from reality, not recognizing any of us. Her condition improved, but she never returned to independent life again. She spent the next seven years in a convalescent home on multiple medications. In the course of those years she developed the Parkinson gait (an awkward shuffling walk), the Parkinson mask (a frozen facial expression, unable to smile), she developed hypothyroidism, tardive dyskinesia (for her a strange chewing of the tongue, then required a pureed food diet), neuroleptic shock (requiring hospitalization twice and changes in meds), fell many times, was put in soft restraints many times, became agressive, and had meds forcibly injected or sprinkled in her food. Finally, in February of 2000, four months after Seroquel was added to her drug mix, she lost the ability to swallow (even water had to be thickened). She had to be aspirated several times. The family was asked about a feeding tube. I had seen her suffer so much, I believed the doctors knew what they were doing, I did not think her condition was reversible or that a "cure" was on the horizon. I said "no" to the feeding tube. The cause of death listed on her death certificate was "bipolar, multiple aspirations". I contacted Astra Zeneca and Eli Lilly and told them I suspected there was a link between her inability to swallow and her medications. I told them that the drugs had caused her death. I sent them her medical records and asked them to review them.

I now know about the new black box warnings and I want to add she did not suffer from dementia before these medications.

I share my story with all the psych doctors and nurses I encounter as a cautionary tale. Young patients will age, and the cumulative effect of multiple meds over many years coupled with the effect of aging needs to always be considered.

Until four months ago, I had no idea how much of her suffering was caused by her medications. I am heartbroken and wish I knew then what I know now thanks to this blog and others like it.

When she died she was taking Depakote 1,000 mg 3x a day, Seroquel 100 mg 4x a day, Olanzipane 10 mg 1x a day, Levo-throid 50 mcg 1x a day.

If I had only known.....

Posted by: Alicia at May 27, 2008 03:32 PM

Oh Alicia, I am so sorry.

Posted by: Stephany at May 27, 2008 07:37 PM
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