January 7, 2011

Newer Antipsychotics Are Overprescribed

Researchers from the Stanford University School of Medicine and the University of Chicago have found that many people currently using a specific type of antipsychotic medication are doing so for a condition that the drug has not yet been proven effective in treating.

According to their findings, published online Friday in the journal Pharmacoepidemiology and Drug Safety, atypical antipsychotic medications were originally approved by the Food and Drug Administration (FDA) in 1989 for treating schizophrenia.

Now, however, they are also being used to treat other conditions, including autism, bipolar disorder, delirium, dementia, depression, personality disorders, and other psychoses. Some of those uses have been approved by the FDA, the researchers said, but some have not.

In a telephone interview with Julie Steenhuysen of Reuters, Dr. Caleb Alexander of the University of Chicago said that these drugs could cause weight gain, diabetes and heart disease.

"What we see is wide adoption for the use of these medications far beyond the evidence base to support it," Alexander added. "We're talking millions of prescriptions a year for antipsychotics in settings where there is uncertain evidence to support them."

In fact, between 1995 and 2008, the total prescriptions for these next-generation antipsychotics, which include such medications as quetiapine (Seroquel), aripoprazole (Abilify), olanzapine (Zyprexa) and risperidone (Risperdal), nearly tripled--from 6.2 million to 16.7 million--researchers from Stanford University said in a press release.

Of those prescriptions, 9 million of them were for conditions that lacked official FDA approval, and more than half (54%) were for conditions where the evidence was uncertain that the drugs would be any help whatsoever.

"Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits," Dr. Randall Stafford, senior author of the study and an associate professor of medicine at the Stanford Prevention Research Center, said in a statement. "These are commonly used and very expensive drugs."

Commonly used, expensive, and dangerous as well - in addition to the health risks previously mentioned by Dr. Alexander, in 2005, the FDA issued a "black box" warning for these new generation antipsychotics, warning that they could actually increase the risk of death for some users, including dementia patients.

"Most people think, 'If my doctor prescribed this, the FDA must have evaluated whether this drug was safe and effective for this use.' That's not true," Stafford added, noting that prescribing medication for purposes other than those approved by the FDA is legal, but potentially riskier for patients.


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