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Study: Older drugs may put elderly at risk
Seattle Post-Intelligencer ^
| December 1, 2005
| STEPHANIE NANO
Posted on 12/02/2005 1:26:24 AM PST by neverdem
ASSOCIATED PRESS
NEW YORK -- Older anti-psychotic drugs are no safer and might even be worse for the elderly than newer ones that the government warned about earlier this year - both raise the risk of death, a study suggests.
The Food and Drug Administration asked drug makers in April to add warnings to the labels of newer anti-psychotics because studies showed the drugs nearly doubled the risk of death for older patients with dementia.
These drugs are widely used to treat the aggressive behavior, delusions and hallucinations sometimes experienced by those with dementia, including Alzheimer's disease.
Researchers at Harvard's Brigham and Women's Hospital in Boston worried that doctors would just switch elderly patients to older medications like Thorazine and Haldol.
The researchers analyzed prescription and death records for nearly 23,000 older patients who took anti-psychotics. They found that 18 percent of patients on the old drugs died in the first six months, compared with 15 percent on the new drugs.
"If confirmed, our results suggest that conventional anti-psychotic medications should be included in the FDA's public health advisory," the researchers said. Their findings appear in Thursday's New England Journal of Medicine.
Dr. Philip Wang, lead author of the study, said studies to determine the best way to treat behavior problems in the elderly are sorely needed. Doctors now rely heavily on tests done in younger people.
"All we can do is encourage clinicians to be thoughtful - to balance whatever benefits there are with what appears to be risk," Wang said.
The study was funded by two federal health agencies.
William Thies, scientific director of the Alzheimer's Association, said he has not seen any evidence that doctors are switching to the older drugs. One of the concerns with the older drugs, he said, is their more severe side effects, including Parkinson's-like tremors and involuntary movements.
While there may be a slight increase in the risk of dying, "these medications are being used to treat a problem which is not trivial," Thies said.
The newer anti-psychotics, such as Risperdal and Seroquel, came out in the 1990s and now account for 95 percent of the prescriptions for anti-psychotics, according to IMS Health, a pharmaceutical information and consulting company.
The drugs were approved by the FDA for treating mental illnesses such as schizophrenia and manic depression, but doctors are free to use them for other problems.
The study, using information from a Pennsylvania prescription program, looked at 22,890 people over 65 who began taking anti-psychotics between 1994 and 2003. Taking into account age, illnesses and other factors, the researchers calculated that those on the older drugs had a 37 percent higher risk of death. The risk was highest for those on higher doses and during the first 40 days of use.
The causes of death were not disclosed. Heart problems and pneumonia accounted for most of the deaths in the studies cited by the FDA in its warning.
On the Net:
New England Journal: http://www.nejm.org
Alzheimer's Association: http://www.alz.org
TOPICS: Business/Economy; Culture/Society; Extended News; Government; News/Current Events; US: District of Columbia; US: Maryland
KEYWORDS: alzheimersdisease; antipsychoticdrugs; dementia; medicine
Risk of Death in Elderly Users of Conventional vs. Atypical Antipsychotic Medications
Philip S. Wang, M.D., Dr.P.H., Sebastian Schneeweiss, M.D., Jerry Avorn, M.D., Michael A. Fischer, M.D., Helen Mogun, M.S., Daniel H. Solomon, M.D., M.P.H., and M. Alan Brookhart, Ph.D.
ABSTRACT
Background Recently, the Food and Drug Administration (FDA) issued an advisory stating that atypical antipsychotic medications increase mortality among elderly patients. However, the advisory did not apply to conventional antipsychotic medications; the risk of death with these older agents is not known.
Methods We conducted a retrospective cohort study involving 22,890 patients 65 years of age or older who had drug insurance benefits in Pennsylvania and who began receiving a conventional or atypical antipsychotic medication between 1994 and 2003. Analyses of mortality rates and Cox proportional-hazards models were used to compare the risk of death within 180 days, less than 40 days, 40 to 79 days, and 80 to 180 days after the initiation of therapy with an antipsychotic medication. We controlled for potential confounding variables with the use of traditional multivariate Cox models, propensity-score adjustments, and an instrumental-variable analysis.
Results Conventional antipsychotic medications were associated with a significantly higher adjusted risk of death than were atypical antipsychotic medications at all intervals studied (
180 days: relative risk, 1.37; 95 percent confidence interval, 1.27 to 1.49; <40 days: relative risk, 1.56; 95 percent confidence interval, 1.37 to 1.78; 40 to 79 days: relative risk, 1.37; 95 percent confidence interval, 1.19 to 1.59; and 80 to 180 days: relative risk, 1.27; 95 percent confidence interval, 1.14 to 1.41) and in all subgroups defined according to the presence or absence of dementia or nursing home residency. The greatest increases in risk occurred soon after therapy was initiated and with higher dosages of conventional antipsychotic medications. Increased risks associated with conventional as compared with atypical antipsychotic medications persisted in confirmatory analyses performed with the use of propensity-score adjustment and instrumental-variable estimation.
Conclusions If confirmed, these results suggest that conventional antipsychotic medications are at least as likely as atypical agents to increase the risk of death among elderly persons and that conventional drugs should not be used to replace atypical agents discontinued in response to the FDA warning.
Source Information
From the Department of Psychiatry (P.S.W.) and the Division of Pharmacoepidemiology and Pharmacoeconomics (P.S.W., S.S., J.A., M.A.F., H.M., D.H.S., M.A.B.), Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston.
Address reprint requests to Dr. Wang at the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, 1620 Tremont St., Suite 3030, Boston, MA 02120, or at pwang{at}rics.bwh.harvard.edu.
Full Text of this Article
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1
posted on
12/02/2005 1:26:26 AM PST
by
neverdem
To: neverdem
Just seeing the word HALDOL broke my heart. This is a mean, mean drug. Doctors prescribed it to my (now X) husband when he was a youthful 25 yrs. of age and oh the horrid effects it had on him. Diagnosed with paranoid schitzophrenia they didn't see in 1990, another drug to use. Had to prescribe 3 more medications just for the side effects of Haldol. No, the elderly can't take this drug, too many hard side effects, can't believe a doctor would even consider it!!!
2
posted on
12/02/2005 3:32:19 AM PST
by
moviegirl
(there are no problems........only solutions)
To: neverdem
I understand that every single one of them (old and new) has some degree of anticholinergic effect. (Dry mouth, difficulty in urination, increased blood pressure, etc.) If big pharm can ever come up with one that does not, it will probably reign king in short order.
To: moviegirl
HALDOL is an amazing, occasional-use anti-psychotic. It has an almost instant effect on people in the throws of a psychotic outburst. Most anti-psychotic drugs take up to four weeks to have an effect.
HALDOL, like many drugs, can be misused and misprescribed. It should not be used for high dosage, long-term use.
4
posted on
12/02/2005 5:26:45 AM PST
by
TaxRelief
To: neverdem
Ritalin in childhood, Prozac in adulthood, Thorazine in old age. It seems opium is the opium of the people, not religion.
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