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New FDA Requirement Puts Warnings On Anti-Psychotic Drugs For Elderly

On Monday, the Food and Drug Administration announced new requirements for warnings on anti-psychotic drugs. The warnings now have to advise they the drugs increase the risk of death in elderly patients suffering from dementia. While ‘atypical’ anti-psychotic drugs have heeded a similar warning since 2005, since requirement is new for ‘conventional’ anti-psychotics like Haldol and Thorazine. In actuality, neither ‘atypical’ nor ‘conventional’ anti-psychotic drugs are approved for use with elderly dementia patients, but are prescribed to them anyway. This is allowed by the FDA, who gives doctors discretion in prescribing for ‘off label’ purposes. Two studies, one in 2005 and one in 2007 concluded that ‘conventional’ anti-psychotics were at least as dangerous as ‘atypicals’ in regard to higher risks of death in elderly patients. This issue may save lives in nursing homes, as ‘conventional’ anti-psychotics are often used to combat agitation or out-of-control behavior, and are likely used often in the nursing home situation, where residents may be chemically restrained. Experts have estimated that as many as one out of every four nursing home residents are taking anti-psychotic drugs. More strikingly, in 2007 an FDA whistle-blower alleged that such medications could be responsible for the deaths of 15,000 nursing home residents every year. Evaluating the new requirement may push to the forefront the issue of whether anti-psychotics are really needed in most nursing home patients who take them, or if they are simply being used to chemically restrain residents in understaffed homes. This change in requirements could lead to wrongful death lawsuits being filed on behalf of nursing home residents who die after being given the anti-psychotic medications.

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