Antipsychotic Medication, Seniors, and Children

"Up to a third of all elderly patients in nursing homes are treated with antipsychotic drugs," U.S. doctors reported two days ago in the British Medical Journal, in an article receiving widespread attention, yet "questions about the comparative safety of individual antipsychotic drugs" remain.

"Some antipsychotic medication may increase the risk of death in patients with dementia more than others," BBC News reported, summarizing the conclusions of the article, which studied the effects of six different kinds of antipsychotic medication on a large (75,445-person) cross-section of elderly patients in nursing homes. The article concluded: "The data suggest that the risk of mortality with these drugs is generally increased with higher doses and seems to be highest for haloperidol [Haldol] and least for quetiapine [Seroquel]."

Due to the results, the researchers—at Harvard Med, Rutgers School of Pharmacy, Columbia, and the Institute for Health, Health Care Policy and Aging Research, Rutgers—determined that the drugs should not be used "in the absence of clear need."

The study is certain to renew widespread concern about the number of seniors prescribed antipsychotic medication. It is also likely to intensify questions about the number of teens, children, and even infants prescribed the same medication off-label for juvenile bipolar disorder.

In March 2009, Florida's St. Petersburg Times reported that in 2007 23 infants less than one-year-old were prescribed antipsychotics off-label, in an attempted "early intervention" against bipolar disorder. The newspaper's title for the story, "Approval Process Lowers the Number of Kids on Atypical Prescriptions," was meant to reassure readers that the numbers were falling: Only 5 one-year-olds were prescribed the drugs the following year, the paper reports. Similarly, "only" 107 three-year-olds, 268 four-year-olds, and 437 five-year-olds on Medicaid in Florida were given the powerful antipsychotics in 2008.

Yet in 2009, BBC News reports, a study commissioned by the UK Department of Health found that "180,000 people with dementia" had been prescribed antipsychotic medication in the UK and that "the drugs [had] resulted in 1,800 additional deaths." The report concluded that there was "an unacceptable level of risk and harm associated with" the drugs, especially among seniors with dementia.

The authors of the recent BMJ article, "Differential Risk of Death in Older Residents in Nursing Homes Prescribed Specific Antipsychotic Drugs," stress that the Food and Drug Administration "issued an advisory warning in 2005 that atypical antipsychotics were associated with a 60-70% increased risk of death compared with placebo in randomized controlled trials among older patients with dementia, and black box warnings were added to the labels of all atypical drugs."

Yet "in the absence of proven effective and safe alternative pharmacological treatments," they add, "it is likely that antipsychotic drugs will continue to be used widely, despite the fact that they have not been approved for this indication, their use cannot be justified as evidence based, and there are clear data confirming their associated risk."

The risks of antipsychotics are "well-established," Rebecca Wood, chief executive of Alzheimer's Research UK, confirmed to BBC News, yet progress on reducing their use "has been frustratingly slow."

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