Health officials in the U.S. are warning doctors that prescribing certain psychiatric drugs to elderly people suffering from dementia can increase their risk of death.
The drugs concerned are antipsychotic drugs originally approved to treat schizophrenia and bipolar disease, but doctors commonly prescribe them for elderly patients with dementia.
The Food and Drug Administration (FDA) warning is an update of advice issued in 2005 when warnings were added to the drugs about an increased heart attack and pneumonia risk - the drugs called atypical antipsychotics include Zyprexa and Risperdal.
According to the FDA the same risks apply to 11 older drugs known as typical or conventional antipsychotics, including Navane and Moban which were developed in the 1950s and have been replaced by newer drugs which have fewer side effects, such as tremors.
Antipsychotic drugs come under two classes, the older "conventional" antipsychotics and the newer "atypical" antipsychotics.
Both classes of drugs are dopamine receptor antagonists that work by blocking the action of naturally occurring dopamine in the brain and differ mainly in the side effects they produce, with the atypical drugs having a lower incidence of neurological side effects such as involuntary movements or "tics."
Neither class of antipsychotic is approved by the FDA for use in the treatment of dementia-related symptoms, which can include forgetfulness, poor memory, and an inability to recognize familiar objects, sounds, or people.
The FDA says both drug types will now carry boxed warnings, the most serious warning a drug can have, describing their risks to dementia patients.
The FDA have repeatedly urged doctors not to medicate seniors unnecessarily but despite such warnings, health professionals continue to prescribe psychiatric drugs "off-label," or for uses that have not been approved by FDA.
According to recent Medicare data as many as 20% of seniors in nursing homes who are given antipsychotics have not been diagnosed with psychiatric problems.
The FDA regulates the approval and marketing of drugs, but doctors are free to use their discretion when prescribing drugs.
The FDA's decision is based on two recent observational epidemiological studies of 65,000 seniors which the FDA says suggested that both classes of drugs should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.
The FDA says it is not clear why antipsychotics hasten death and scientists also are unable to determine from the data whether one group carries greater dangers than the other, which has prompted the FDA to label both classes of drugs with the warning.
The FDA says there is "no approved drug for the treatment of dementia-related psychosis," and recommends that doctors consider other treatment options.
Experts say much can be done to help change an environment so that elderly patients are more oriented and engaged and many of the behavioural problems displayed by seniors can be improved with simple, daily routines that patients are able to follow.
The manufacturers of both classes of drugs are being asked to change labeling so that all of the drugs carry uniform warning language.
People taking antipsychotic drugs are advised to not abruptly stop taking them and caregivers and patients should talk to health care professionals involved about any concerns.
The medications involved in this action are:
Conventional antipsychotic drugs - Compazine, Haldol, Loxitane, Mellaril, Moban, Navane, Orap, Prolixin, Stelazine, Thorazine and Trilafon.
Atypical antipsychotics are - Abilify, Clozaril, FazaClo, Geodon, Invega, Risperdal, Seroquel, Zyprexa and Symbyax.