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FDA: Antipsychotics Risky for Elderly

FDA: Antipsychotics Risky for Elderly The US Food and Drug Administration (FDA) is warning physicians that using conventional antipsychotic drugs to treat elderly patients with dementia may increase the risk of death in these patients. In 2005, the agency warned of similar risks associated with newer atypical antipsychotic drugs. Antipsychotic medications pose particular health risks to elderly patients with dementia. Under new authority granted to the agency by the Food and Drug Administration Amendments Act of 2007, the agency is requiring manufacturers of conventional antipsychotics (which include prochlorperazine, haloperidol, loxapine, thioridazine, molindone, thiothixene, pimozide, fluphenazine, trifluoperazine, chlorpromazine, and perphenazine) to add a boxed warning to the labels of these drugs notifying physicians that using conventional antipsychotics to treat behavioral problems in elderly patients with dementia is associated with an increased risk of death. Previously, the agency could only request and negotiate for such a change. The agency is also requiring manufacturers of atypical antipsychotics to revise the existing boxed warning on these drugs, which include aripiprazole, clozapine, ziprasidone, paliperidone, risperidone, quetiapine, olanzapine, and a combination drug containing olanzapine and fluoxetine. Antipsychotic drugs are not approved by the FDA for the treatment of patients with dementia. However, these drugs are commonly used off-label to treat dementia-related psychosis in elderly patients. Such usage has increased rapidly in recent years. According to a 2001 report by the Department of Health and Human Services Office of the Inspector General, 16% of all nursing home patients were taking antipsychotic drugs in 1995, and the proportion reached 19.4% by 1999. According to the Centers for Medicare & Medicaid Services, close to a third of all nursing home patients are currently taking the drugs. Conventional antipsychotics have been used to treat elderly patients for decades, said Constantine G. Lyketsos, MD, MHS, chair of the department of psychiatry at Johns Hopkins Bayview Medical Center in Baltimore. Yet until recently, data were lacking on whether the drugs might pose specific risks to this population. When randomized controlled trials of atypical antipsychotics identified an increased risk of mortality, researchers began combing large databases to determine whether conventional antipsychotics posed a similar risk. The latest warning from the FDA stems from 2 observational studies that suggest both conventional and atypical antipsychotics are associated with an increased risk of death in elderly patients (Gill SS et al. Ann Intern Med. 2007;146[11]:775-786 and Schneeweiss S et al. CMAJ. 2007;176[5]:627-632). Thomas Laughren, MD, director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research, explained that despite the potential limitations of such observational studies, the agency felt the data were strong enough to justify the warning. “It is important to recognize that this is not a contraindication,” he said. “Physicians still have the option of using [antipsychotics] to treat this aspect of dementia at their discretion; however, [the drugs] are not approved for this indication and we want clinicians to be aware of the risks.” The 2005 warning on atypical antipsychotics was based on an FDA meta-analysis of 17 placebo-controlled trials of olanzapine, aripiprazole, risperidone, or quetiapine in elderly patients with dementia and behavioral problems. This meta-analysis found that over the course of the 10-week trials, patients taking these medications had a 4.5% risk of dying, while those taking placebo had a 2.6% risk of dying, Laughren said. The two observational studies, which compared patients taking conventional antipsychotics with those taking atypical antipsychotics, found that death rates were comparable, or possibly higher among patients taking conventional antipsychotics. The mechanism by which antipsychotics may increase the risk of death in these patients is unclear, said Laughren. Physicians treating elderly patients with dementia-related psychosis face difficult choices. Antipsychotics have been a mainstay of such treatment, despite demonstrating only modest effects. There is little evidence supporting the effectiveness of other psychotropic medications, though Lyketsos noted that a recent analysis reassuringly found that such drugs as selective serotonin reuptake inhibitors and anticonvulsants are not associated with an elevated mortality risk in this population (Kales HC et al. Am J Psychiatry. 2007; 164[10]:1568-1576). Behavioral interventions may work in some cases, though few facilities know how to implement them, he said. Lyketsos said more research is needed to clarify these issues. “It's a huge problem because we are sort of stuck,” Lyketsos added. “The behavior problems are not going away and they carry their own risks of mortality and morbidity, and we don't know how to treat them safely.” The US Food and Drug Administration (FDA) is warning physicians that using conventional antipsychotic drugs to treat elderly patients with dementia may increase the risk of death in these patients. In 2005, the agency warned of similar risks associated with newer atypical antipsychotic drugs. Under new authority granted to the agency by the Food and Drug Administration Amendments Act of 2007, the agency is requiring manufacturers of conventional antipsychotics (which include prochlorperazine, haloperidol, loxapine, thioridazine, molindone, thiothixene, pimozide, fluphenazine, trifluoperazine, chlorpromazine, and perphenazine) to add a boxed warning to the labels of these drugs notifying physicians that using conventional antipsychotics to treat behavioral problems in elderly patients with dementia is associated with an increased risk of death. Previously, the agency could only request and negotiate for such a change. The agency is also requiring manufacturers of atypical antipsychotics to revise the existing boxed warning on these drugs, which include aripiprazole, clozapine, ziprasidone, paliperidone, risperidone, quetiapine, olanzapine, and a combination drug containing olanzapine and fluoxetine. Antipsychotic drugs are not approved by the FDA for the treatment of patients with dementia. However, these drugs are commonly used off-label to treat dementia-related psychosis in elderly patients. Such usage has increased rapidly in recent years. According to a 2001 report by the Department of Health and Human Services Office of the Inspector General, 16% of all nursing home patients were taking antipsychotic drugs in 1995, and the proportion reached 19.4% by 1999. According to the Centers for Medicare & Medicaid Services, close to a third of all nursing home patients are currently taking the drugs. Conventional antipsychotics have been used to treat elderly patients for decades, said Constantine G. Lyketsos, MD, MHS, chair of the department of psychiatry at Johns Hopkins Bayview Medical Center in Baltimore. Yet until recently, data were lacking on whether the drugs might pose specific risks to this population. When randomized controlled trials of atypical antipsychotics identified an increased risk of mortality, researchers began combing large databases to determine whether conventional antipsychotics posed a similar risk. The latest warning from the FDA stems from 2 observational studies that suggest both conventional and atypical antipsychotics are associated with an increased risk of death in elderly patients (Gill SS et al. Ann Intern Med. 2007;146[11]:775-786 and Schneeweiss S et al. CMAJ. 2007;176[5]:627-632). Thomas Laughren, MD, director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research, explained that despite the potential limitations of such observational studies, the agency felt the data were strong enough to justify the warning. “It is important to recognize that this is not a contraindication,” he said. “Physicians still have the option of using [antipsychotics] to treat this aspect of dementia at their discretion; however, [the drugs] are not approved for this indication and we want clinicians to be aware of the risks.” The 2005 warning on atypical antipsychotics was based on an FDA meta-analysis of 17 placebo-controlled trials of olanzapine, aripiprazole, risperidone, or quetiapine in elderly patients with dementia and behavioral problems. This meta-analysis found that over the course of the 10-week trials, patients taking these medications had a 4.5% risk of dying, while those taking placebo had a 2.6% risk of dying, Laughren said. The two observational studies, which compared patients taking conventional antipsychotics with those taking atypical antipsychotics, found that death rates were comparable, or possibly higher among patients taking conventional antipsychotics. The mechanism by which antipsychotics may increase the risk of death in these patients is unclear, said Laughren. Physicians treating elderly patients with dementia-related psychosis face difficult choices. Antipsychotics have been a mainstay of such treatment, despite demonstrating only modest effects. There is little evidence supporting the effectiveness of other psychotropic medications, though Lyketsos noted that a recent analysis reassuringly found that such drugs as selective serotonin reuptake inhibitors and anticonvulsants are not associated with an elevated mortality risk in this population (Kales HC et al. Am J Psychiatry. 2007; 164[10]:1568-1576). Behavioral interventions may work in some cases, though few facilities know how to implement them, he said. Lyketsos said more research is needed to clarify these issues. “It's a huge problem because we are sort of stuck,” Lyketsos added. “The behavior problems are not going away and they carry their own risks of mortality and morbidity, and we don't know how to treat them safely.” Antipsychotic medications pose particular health risks to elderly patients with dementia. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

FDA: Antipsychotics Risky for Elderly

JAMA , Volume 300 (4) – Jul 23, 2008

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Publisher
American Medical Association
Copyright
Copyright © 2008 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.300.4.379
Publisher site
See Article on Publisher Site

Abstract

The US Food and Drug Administration (FDA) is warning physicians that using conventional antipsychotic drugs to treat elderly patients with dementia may increase the risk of death in these patients. In 2005, the agency warned of similar risks associated with newer atypical antipsychotic drugs. Antipsychotic medications pose particular health risks to elderly patients with dementia. Under new authority granted to the agency by the Food and Drug Administration Amendments Act of 2007, the agency is requiring manufacturers of conventional antipsychotics (which include prochlorperazine, haloperidol, loxapine, thioridazine, molindone, thiothixene, pimozide, fluphenazine, trifluoperazine, chlorpromazine, and perphenazine) to add a boxed warning to the labels of these drugs notifying physicians that using conventional antipsychotics to treat behavioral problems in elderly patients with dementia is associated with an increased risk of death. Previously, the agency could only request and negotiate for such a change. The agency is also requiring manufacturers of atypical antipsychotics to revise the existing boxed warning on these drugs, which include aripiprazole, clozapine, ziprasidone, paliperidone, risperidone, quetiapine, olanzapine, and a combination drug containing olanzapine and fluoxetine. Antipsychotic drugs are not approved by the FDA for the treatment of patients with dementia. However, these drugs are commonly used off-label to treat dementia-related psychosis in elderly patients. Such usage has increased rapidly in recent years. According to a 2001 report by the Department of Health and Human Services Office of the Inspector General, 16% of all nursing home patients were taking antipsychotic drugs in 1995, and the proportion reached 19.4% by 1999. According to the Centers for Medicare & Medicaid Services, close to a third of all nursing home patients are currently taking the drugs. Conventional antipsychotics have been used to treat elderly patients for decades, said Constantine G. Lyketsos, MD, MHS, chair of the department of psychiatry at Johns Hopkins Bayview Medical Center in Baltimore. Yet until recently, data were lacking on whether the drugs might pose specific risks to this population. When randomized controlled trials of atypical antipsychotics identified an increased risk of mortality, researchers began combing large databases to determine whether conventional antipsychotics posed a similar risk. The latest warning from the FDA stems from 2 observational studies that suggest both conventional and atypical antipsychotics are associated with an increased risk of death in elderly patients (Gill SS et al. Ann Intern Med. 2007;146[11]:775-786 and Schneeweiss S et al. CMAJ. 2007;176[5]:627-632). Thomas Laughren, MD, director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research, explained that despite the potential limitations of such observational studies, the agency felt the data were strong enough to justify the warning. “It is important to recognize that this is not a contraindication,” he said. “Physicians still have the option of using [antipsychotics] to treat this aspect of dementia at their discretion; however, [the drugs] are not approved for this indication and we want clinicians to be aware of the risks.” The 2005 warning on atypical antipsychotics was based on an FDA meta-analysis of 17 placebo-controlled trials of olanzapine, aripiprazole, risperidone, or quetiapine in elderly patients with dementia and behavioral problems. This meta-analysis found that over the course of the 10-week trials, patients taking these medications had a 4.5% risk of dying, while those taking placebo had a 2.6% risk of dying, Laughren said. The two observational studies, which compared patients taking conventional antipsychotics with those taking atypical antipsychotics, found that death rates were comparable, or possibly higher among patients taking conventional antipsychotics. The mechanism by which antipsychotics may increase the risk of death in these patients is unclear, said Laughren. Physicians treating elderly patients with dementia-related psychosis face difficult choices. Antipsychotics have been a mainstay of such treatment, despite demonstrating only modest effects. There is little evidence supporting the effectiveness of other psychotropic medications, though Lyketsos noted that a recent analysis reassuringly found that such drugs as selective serotonin reuptake inhibitors and anticonvulsants are not associated with an elevated mortality risk in this population (Kales HC et al. Am J Psychiatry. 2007; 164[10]:1568-1576). Behavioral interventions may work in some cases, though few facilities know how to implement them, he said. Lyketsos said more research is needed to clarify these issues. “It's a huge problem because we are sort of stuck,” Lyketsos added. “The behavior problems are not going away and they carry their own risks of mortality and morbidity, and we don't know how to treat them safely.” The US Food and Drug Administration (FDA) is warning physicians that using conventional antipsychotic drugs to treat elderly patients with dementia may increase the risk of death in these patients. In 2005, the agency warned of similar risks associated with newer atypical antipsychotic drugs. Under new authority granted to the agency by the Food and Drug Administration Amendments Act of 2007, the agency is requiring manufacturers of conventional antipsychotics (which include prochlorperazine, haloperidol, loxapine, thioridazine, molindone, thiothixene, pimozide, fluphenazine, trifluoperazine, chlorpromazine, and perphenazine) to add a boxed warning to the labels of these drugs notifying physicians that using conventional antipsychotics to treat behavioral problems in elderly patients with dementia is associated with an increased risk of death. Previously, the agency could only request and negotiate for such a change. The agency is also requiring manufacturers of atypical antipsychotics to revise the existing boxed warning on these drugs, which include aripiprazole, clozapine, ziprasidone, paliperidone, risperidone, quetiapine, olanzapine, and a combination drug containing olanzapine and fluoxetine. Antipsychotic drugs are not approved by the FDA for the treatment of patients with dementia. However, these drugs are commonly used off-label to treat dementia-related psychosis in elderly patients. Such usage has increased rapidly in recent years. According to a 2001 report by the Department of Health and Human Services Office of the Inspector General, 16% of all nursing home patients were taking antipsychotic drugs in 1995, and the proportion reached 19.4% by 1999. According to the Centers for Medicare & Medicaid Services, close to a third of all nursing home patients are currently taking the drugs. Conventional antipsychotics have been used to treat elderly patients for decades, said Constantine G. Lyketsos, MD, MHS, chair of the department of psychiatry at Johns Hopkins Bayview Medical Center in Baltimore. Yet until recently, data were lacking on whether the drugs might pose specific risks to this population. When randomized controlled trials of atypical antipsychotics identified an increased risk of mortality, researchers began combing large databases to determine whether conventional antipsychotics posed a similar risk. The latest warning from the FDA stems from 2 observational studies that suggest both conventional and atypical antipsychotics are associated with an increased risk of death in elderly patients (Gill SS et al. Ann Intern Med. 2007;146[11]:775-786 and Schneeweiss S et al. CMAJ. 2007;176[5]:627-632). Thomas Laughren, MD, director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research, explained that despite the potential limitations of such observational studies, the agency felt the data were strong enough to justify the warning. “It is important to recognize that this is not a contraindication,” he said. “Physicians still have the option of using [antipsychotics] to treat this aspect of dementia at their discretion; however, [the drugs] are not approved for this indication and we want clinicians to be aware of the risks.” The 2005 warning on atypical antipsychotics was based on an FDA meta-analysis of 17 placebo-controlled trials of olanzapine, aripiprazole, risperidone, or quetiapine in elderly patients with dementia and behavioral problems. This meta-analysis found that over the course of the 10-week trials, patients taking these medications had a 4.5% risk of dying, while those taking placebo had a 2.6% risk of dying, Laughren said. The two observational studies, which compared patients taking conventional antipsychotics with those taking atypical antipsychotics, found that death rates were comparable, or possibly higher among patients taking conventional antipsychotics. The mechanism by which antipsychotics may increase the risk of death in these patients is unclear, said Laughren. Physicians treating elderly patients with dementia-related psychosis face difficult choices. Antipsychotics have been a mainstay of such treatment, despite demonstrating only modest effects. There is little evidence supporting the effectiveness of other psychotropic medications, though Lyketsos noted that a recent analysis reassuringly found that such drugs as selective serotonin reuptake inhibitors and anticonvulsants are not associated with an elevated mortality risk in this population (Kales HC et al. Am J Psychiatry. 2007; 164[10]:1568-1576). Behavioral interventions may work in some cases, though few facilities know how to implement them, he said. Lyketsos said more research is needed to clarify these issues. “It's a huge problem because we are sort of stuck,” Lyketsos added. “The behavior problems are not going away and they carry their own risks of mortality and morbidity, and we don't know how to treat them safely.” Antipsychotic medications pose particular health risks to elderly patients with dementia.

Journal

JAMAAmerican Medical Association

Published: Jul 23, 2008

Keywords: antipsychotic agents,united states food and drug administration,older adult

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