The US FDA announced on June 17, 2008 that a “black box” warning should be added on the labels of conventional antipsychotics such as haldol and thorazine, which are sometimes used to pacify dementia patients who become aggressive or disturbed.

I am immensely happy knowing the US FDA’s new warning. Use of conventional antipsychotics for elderly dementia patients has taken away lives of a few patients….I really wish that now there will be an end for such tragic deaths! Giving these antipsychotics, even in reduced doses, to frail elderly patients often in poor health is awful. Isn’t it?

I think prescribing antipsychotics trivially is merely ‘inhumane act’. The key for medics and patients, is knowing that they are dangerous, thinking through options then using them when appropriate with an awareness.

Elderly patients with dementia who are being treated with an older class of antipsychotics appear to be at increased risk of dying. A majority of elderly patients with dementia develop aggression, delusions, and other neuropsychiatric symptoms during their illness course. Antipsychotics are commonly used to treat these behaviors, along with psychosocial and environmental interventions. Although information on the use of the older antipsychotics in nursing homes and elsewhere is spotty, the regulatory agency said that it thinks the older antipsychotics were not as widely used as the newer ones, which include Risperdal, Zyprexa and Seroquel. Thomas Laughren, Director of the FDA’s Division of Psychiatry Products in the Center for Drug Evaluation and Research, said that none of the drugs is currently approved for use among elderly patients with dementia.

FDA officials issued a similar warning for newer antipsychotics (Abilify, Zyprexa) in 2005. Dr. Thomas Laughren said that the older antipsychotics are only now receiving the black box warning because previously there had not been enough data.

Shilpa C Nangali