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Alzheimer News 4/19/2005
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FDA issues advisory on atypical antipsychotics

The U.S. Food and Drug Administration (FDA) today issued a public health advisory on the use of a class of drugs called "atypical antipsychotics" to treat agitation, aggression, hallucinations, delusions and other behavioral and psychiatric symptoms of Alzheimer's disease. The purpose of the advisory is to alert health care professionals and consumers that taking these drugs is associated with an increased risk of death for individuals with dementia. This conclusion is based on FDA's analysis of 17 studies, which showed that those taking the drugs had an increased death rate compared with those taking a placebo (inactive treatment).

Alzheimer's Association science advisors familiar with the data say that the number of deaths in the placebo group was about one percent of participants and the number in the group receiving atypical antipsychotic drugs was between one-and-one-half and two percent. The analysis has not yet been published.

Although the deaths were from various causes, many appeared to be heart-related or due to pneumonia or other infections.

FDA is requiring manufacturers of all drugs of this type to add a "black box" warning to their products alerting the public of the increased death risk. The boxed warning must also note that none of these drugs is approved by FDA to treat dementia symptoms. In addition, FDA advises any patients with dementia currently receiving these drugs to have their treatment reviewed by their physician.

Atypical antipsychotic drugs covered by FDA's advisory include:

  • olanzapine (Zyprexa)

  • aripiprazole (Abilify)

  • risperidone (Risperdal)

  • quetiapine (Seroquel)

  • clozapine (Clozaril)

  • ziprasidone (Geodon)

  • olanzapine/fluoxetine (Symbyax)

These drugs are approved by FDA to treat symptoms of schizophrenia and bipolar disorder (manic depression).

Alzheimer's Association science staff and advisors offer the following observations on the FDA action and the use of these drugs to treat behavioral and psychiatric symptoms of dementia.

About the FDA action:

  • The increased risk of death revealed by the analysis is "real but small" and should become part of a complete and thoughtful benefit/risk discussion about use of these drugs involving the physician, the family and the individual with dementia. These drugs are also associated with other potentially serious side effects that should be considered in the risk/benefit discussion.

  • Although none of these drugs has ever been specifically approved to treat behavioral and psychiatric dementia symptoms, mainstream clinical consensus is that there are times when their use for this purpose is an important and appropriate option for physicians to consider.

About behavioral and psychiatric Alzheimer symptoms:

  • Behavioral and psychiatric problems eventually affect many individuals with Alzheimer's. These symptoms are associated with the later stages of the disease and are often a signal of rapid decline. They cause profound distress to individuals with the disease and may put them at risk of injury.

  • These symptoms can also create difficult situations for family caregivers and are often a determining factor in deciding to place the diagnosed individual in residential care.

  • Behavioral symptoms can also have a negative effect on care and quality of life for those living in long-term care facilities.

  • It is important whenever possible to identify correctable factors that may trigger behavioral symptoms, such as urinary tract or other underlying infections, constipation, pain, or environmental discomforts (temperature extremes, insufficient light, loud noise).

  • When the physician, family and individual with dementia or the surrogate medical decision-maker agree that trying a drug treatment is an appropriate next step, atypical antipsychotics are the drugs that have been most extensively studied for this purpose.

  • Most studies have shown that the antipsychotic drugs are modestly effective at treating these symptoms. These drugs may not help all individuals and may help some more than others.

  • An individual taking antipsychotic drugs should be carefully monitored for response to treatment and side effects.

  • These drugs should not be overused and ongoing need for the drug should be carefully evaluated.

  • Research in this area remains ongoing. A large clinical trial funded by the National Institute of Mental Health (NIMH) is comparing the effectiveness of three atypical antipsychotics and one antidepressant in treating behavioral and psychiatric symptoms of dementia. This trial is Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE).

  • Through its own research program, advocacy for greater public funding and collaborative relationships with pharmaceutical companies, the Alzheimer's Association strongly supports the effort to develop safer, more effective treatments for Alzheimer's disease as well as preventive strategies.

For more information, please see:

  • FDA's "Talk Paper" on today's public health advisory

  • FDA's public health advisory

  • FDA's information page on atypical antipsychotic drugs, including information sheets for health professionals and consumers

  • Alzheimer's Association fact sheet on behavioral and psychiatric symptoms of dementia


Alzheimer's Association

Our vision: A world without Alzheimer's disease®.
Formed in 1980, the Alzheimer's Association is the leading voluntary health organization in Alzheimer's care, support and research.