Antipsychotics Offer Modest Benefits for Non-Approved Conditions
Study Examines Risks and Benefits of Drugs Used for Conditions Not Specifically Approved by FDA
Sept. 27, 2011 -- A new research review shows that powerful drugs approved to treat schizophrenia, bipolar disorder, and depression may have modest benefits when they are prescribed for certain other mental and behavioral problems.
The study is published in the Journal of the American Medical Association.
Researchers combed the medical literature to summarize benefits and risks of so-called "off-label" uses of atypical antipsychotics such as Abilify, Risperdal, Seroquel, and Zyprexa.
Off-label refers to drugs prescribed for conditions for which they were not approved by the FDA to treat. It is legal to use a medication for these off-label reasons as long as the drug has been FDA-approved for at least one condition.
In patients with dementia, for example, doctors sometimes use atypical antipsychotics to treat symptoms of agitation and aggression. More controversially, the drugs have been prescribed to treat attention deficit hyperactivity disorder in kids.
The growing use of off-label drugs has come under scrutiny from federal regulators in recent years.
Drugmakers have long defended the practice of off-label prescribing. They say it offers doctors important flexibility in making treatment decisions for individual patients.
"Patient safety is a core priority for AstraZeneca and we believe that Seroquel and Seroquel XR are safe and effective medications when used as recommended in the prescribing information," says Stephanie Andrzejewski, director of brand corporate affairs.
"Further, we trust doctors to use their medical judgment to determine when it is appropriate to prescribe medications," she says.
"Bristol-Myers Squibb and Otsuka Pharmaceutical support the use of Abilify (aripiprazole) for its approved indications, when used in accordance with the prescribing information," says Sonia Choi, director of public affairs for those companies.
Eli Lilly, the maker of Zyprexa, says in a statement emailed to WebMD: "Lilly is committed to the highest ethical standards and to promoting
our medications only for approved uses."
The statement notes that "a substantial body of evidence supports Zyprexa's overall safety and efficacy profile for the indications for which it is currently approved. Because patients may respond differently to different medications, it's necessary for physicians to evaluate and discuss risks versus
benefits openly with patients and their families to understand what the best treatment options might be for each individual."
Measuring Benefits and Harms
Information from 162 studies was included in the review.
Researchers say there's some evidence that certain atypical antipsychotics may offer modest amounts of help for dementia, generalized anxiety disorder, posttraumatic stress disorder (PTSD), and obsessive-compulsive disorder (OCD).
The drugs do not appear to benefit eating disorders or substance abuse.
"We didn't see dramatic benefits," says researcher Alicia Ruelaz Maher, MD, a psychiatrist and researcher at RAND, a nonprofit research organization. She is also a clinical associate professor at the University of California, Los Angeles.