The so-called black box warning was issued by the Food and Drug Administration in 2005 after studies found elderly people on newer antipsychotics such as Janssen’s Risperdal and AstraZeneca’s Seroquel died sooner than those who didn’t take the drugs.

“The black box warning is really the strongest warning that FDA has short of pulling the drug off the market,” said Dr. Helen C. Kales, a psychiatrist at the University of Michigan in Ann Arbor, who worked on the study. “It looks like the warning did have its intended effect.”

Some doctors use antipsychotics to control difficult behaviors in old people with dementia, although they haven’t been specifically approved for the purpose.

More than one in ten Americans over 70 have dementia, and often that causes problems like frequent agitation, aggression, paranoia, and delusions.

“A lot of time and money are spent dealing with these things,” Kales said.

Based on data in the national Veterans Affairs registries from more than 250,000 veterans, she and colleagues found the overall use of new and old antipsychotics in elderly patients with dementia dropped from nearly 18 percent in 1999 to 12 percent in 2007.

While doctors used the older drugs less and less over the entire period, the newer ones became increasingly popular until 2003, when early warnings began to circulate among healthcare providers.

Then in 2005, use of newer antipsychotics suddenly began dropping, too.

“We began to be aware that there was no free lunch,” Kales told Reuters Health, noting that doctors had hoped initially that the newer medications — also known as “atypical antipsychotic drugs” –would have fewer side effects than the older ones.

As it turned out, they replaced one set of side effects — such as movement disorders — with others, such as pronounced weight gain and diabetes.

Kales said antipsychotics might still have a place in treating some psychotic elderly patients, but they should be used cautiously.

For instance, simple things such as switching a male for a female caregiver might ease symptoms in some patients, whereas antidepressants may help others.

Kales also said she now discusses the risks and benefits of using antipsychotics with the family before putting a patient on the drug.

“The take-home message for me is we need to continue to look for better treatments, perhaps by studying behavioral interventions,” Kales said. “There is still a group of patients out there who really need help.”

SOURCE: http://bit.ly/iiwWKH Archives of General Psychiatry, online February 7, 2011.

Technorati Tags: Antipsychotics, Dementia, Risperdal, Seroquel

Their study, published in the May issue of the journal Archives of Neurology, included 49 people who’d been diagnosed with very mild Alzheimer’s disease. Samples of cerebrospinal fluid taken from the patients were tested for several biomarkers associated with Alzheimer’s, including alpha-beta peptide 1-42 (Aβ42), tau, and phosphorylated tau 181 (ptau 181).

The patients had at least one follow-up assessment an average of 3.5 years later and the researchers found that the “rate of dementia progression was significantly more rapid in individuals with lower baseline cerebrospinal fluid Aβ42 levels, higher tau or ptau 181 levels or high tau:Aβ42 ratios.”

Finding effective treatments for Alzheimer’s will likely depend on early identification of patients, noted study author Dr. Barbara J. Snider and colleagues at Washington University School of Medicine in St. Louis.

“Because there is a growing emphasis on enrolling individuals with less cognitive impairment into clinical trials of [possible] anti-Alzheimer’s disease agents, methods are needed that will identify individuals with very mild dementia of the Alzheimer’s type who are more likely to exhibit measurable cognitive decline during the study,” the researchers wrote.

“Although the number of participants in this study was relatively small, the results suggest that cerebrospinal fluid biomarkers might be useful as entry criteria for clinical trials of disease-modifying therapies for mild cognitive impairment and very mild dementia of the Alzheimer type,” they noted.

The study findings may “have important implications for reducing the number of participants needed to show an effect in clinical trials for very mild dementia of the Alzheimer type and mild cognitive impairment and, ultimately, to assist in making treatment decisions as more invasive and potentially harmful disease-modifying treatments for Alzheimer’s disease become available,” the authors concluded.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about dementia.

Technorati Tags: Alzheimers, anti alzheimer, Dementia