NEW YORK (Reuters Health) - An official warning about newer antipsychotics in demented elderly people appears to have deterred some doctors from prescribing the drugs, a new U.S. study shows.
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: bit.ly/iiwWKH Archives of General Psychiatry, online February 7, 2011.