FDA Warns Doctors Antipsychotics Risky for Elderly

Christine Kennard Health Pro
  • The US Food and Drug Administration (FDA) has issued a warning to physicians that conventional antipsychotic medication, used to treat behavioral problems in elderly people suffering from dementia, can increase their risk of death.


    Conventional antipsychotic medications, also known as major tranquillizers, include haloperidol, thioridazine, fluphenazine, thiothixene, pimozide, trifluoperazine and perphenazine. Some of these drugs have been used since the 1960s. They revolutionized psychiatric treatment offered to people with psychotic illnesses who had been previously incarcerated in hospitals for decades.

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    Antipsychotic drugs, although not approved by the FDA for treatment of patients with dementia, are still prescribed and their use has increased substantially in the past 20 years or so. According to the Center for Medicare and Medicaid Services nearly a third of all nursing home residents are prescribed antipsychotic medication.


    The FDA is also exercising its new authority under the Administration Amendments Act 2007, by requiring manufacturers to put a boxed warning on the labels of conventional and atypical antipsychotic drugs stating that their use is associated with increase risk of death in elders.


    The new warning is a result of two observational studies by Gill and his research team and by Schneeweiss et al, that have shown conventional as well as atypical antipsychotic medications carry an increased risk of death in the elderly. The FDA have previously issued a similar warning about the more recent group of medications, known as atypical antipsychotics, which include olanzapine, resperidone, quetiapine and aripiprazole.


    Thomas Langhren, MD, Director of the FDA Division of Psychiatry Products in the Center for Drug Evaluation and Research, has said of the warning that data are important and strong enough to "justify the warning". Langhren says this type of medication can still be used and are not contraindicated in elderly demented people. However, it does mean that clinicians are now aware of the risk factors associated with their use. Why conventional and atypical antipsychotic drugs increase the risk of mortality is unclear.


    The association between increased risk of mortality associated with conventional and atypical antipsychotic medication presents something of an ethical dilemma. In an ideal world the use of medication is associated with affecting a cure. Of course there are many chronic diseases where the most medication can do is help to improve quality of life. In the case of dementia, which is a progressive degenerative disease, a balance always needs to be struck over the needs of the patient against those of the caregiver. In many cases the person with dementia is cared for by someone who is frail and elderly and unable to cope with some of the behavioral problems associated with dementia. In care homes the problems may be just as complex but for different reasons. Care home staff have the needs of other residents to consider so the pressure to recommend medication for more behaviourally disturbed residents is always an issue. Wherever possible it is good to consider alternatives to medication. If prescribed, it then becomes necessary for everyone, caregiver, relative or friend, to carefully monitor the effects and act as advocate for the patient.

Published On: July 30, 2008