Atypical antipsychotics have also been studied for treating
Tourette syndrome and
"Off-label use isn't necessarily bad," Atkins said. "To say it's not an approved indication doesn't mean there's no evidence."
But after reviewing 84 published studies on atypical
antipsychotics, the authors of the new study concluded there can be
problems. Not only is quality evidence lacking to support off-label
use of the drugs, there is evidence of severe side effects,
including weight gain, tremors and
"These drugs have a lot of side effects," Licinio confirmed. "They also tend to be very expensive."
Although some patients can benefit from the off-label use, many can be treated with a different drug without the side effects, he added.
The drugs are also used widely in children for off-label purposes, said Dr. Cheryl Corcoran, assistant professor of psychiatry at Columbia University and a researcher in schizophrenia at the New York State Psychiatric Institute in New York City.
"There are very few clinical trials in children, but there's
enough information from other sources to show that these
medications can be very problematic for children, with side effects
such as weight gain, insulin resistance and changes in
Licinio added there are few studies that looked at the drugs in "real-world" settings, which often means in combination with other drugs. "It's not only that people are getting anti-psychotics, they are being added to what they are already taking," he said. "They are being added, and they have not been tested in combinations, and I think it's a problem."
The study authors called for more head-to-head trials of the drugs.
"The clearest finding was that the quality of evidence for the most common uses was not very clear-cut, which doesn't prove the case that these aren't appropriate to consider in individual patients. But it does say that given the amount of use they're getting, we need some better research to try to clarify how to identify the right patients to get these drugs," Atkins said.
But Corcoran and others called for a different approach.
"Our sense is not more head-to-head trials but the need to develop other kinds of treatments for disorders other than psychosis, drugs that are safer, more appropriate, using rationale drug design," she said.
More information
View the full report at AHRQ.
