FiercePharma
By Tracy Staton
September 27, 2011

Off-label use of powerful antipsychotic drugs has come in for plenty of debate in recent years. The expensive, newer-generation “atypicals” have been used to treat dementia, depression, anxiety, post-traumatic stress disorder, dementia, attention-deficit hyperactivity disorder…the list goes on. And all this while the Justice Department was investigating Big Pharma for off-label promotion of the drugs.

An updated analysis now finds that antipsychotic drugs’ utility in off-label uses is minimal, but the risks are significant, Medscape reports. Several illnesses didn’t respond at all to antipsychotic therapy, the data showed, including eating disorders and addiction problems. The evidence for treatment of personality disorders was a toss-up. Meanwhile, side effects were sometimes severe, including weight gain, metabolic problems, fatigue, urinary tract symptoms and even an increased risk of death, the researchers said.

A few off-label uses won support from the new data. Anxiety patients got moderate benefit from AstraZeneca’s ($AZN) Seroquel, and OCD sufferers were helped by treatment with Johnson & Johnson’s ($JNJ) Risperdal. Elderly patients with dementia saw a small benefit with antipsychotic use.

“We need to use this information and be wary of prescribing when it isn’t warranted,” said Dr. Alicia Ruelaz Maher, lead author of the JAMA-published study. “I think the biggest takeaway is that instead of just prescribing blindly, we now have evidence to guide us.” And, as Maher told Reuters, “Each individual patient needs to be considered as opposed to, ‘This is good for this condition.'”

http://www.fiercepharma.com/story/jama-spotty-results-label-antipsychotic-use/2011-09-28