New antipsychotic drugs costly, lack evidence for effectiveness

Kathleen Blanchard's picture
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New antipsychotic drugs may not be useful, despite their widespread use.

The use of drugs to treat conditions like depression, dementia, autism bipolar disorder, schizophrenia and other personality disorders has steadily risen, but researchers says second generation antipsychotics cost millions, may not even help patients, and have serious side effects that should be considered, including weight gain, diabetes and heart disease.

Stanford University School of Medicine and University of Chicago researchers suggest most of their use comes from marketing and not medical evidence that the medications work.

Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, who is senior author of the study says, "Physicians want to prescribe and use the latest therapies — and even when those latest therapies doesn't necessarily offer a big advantage, there's still a tendency to think that the newest drugs must be better." In the case of antipsychotics, the scientist found 54 percent of the drugs prescribed lacked definite evidence that they're effective.

They also found the cost of antipsychotic medications was $6 billion for off-label use and $5.4 billion in spending accounted for drug use with uncertain evidence. Prescriptions for the medications that lack FDA approval spike from 4.4 million in 1995 to 9 million in 1998.

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From the study, the Stanford scientists found antipsychotic drug use rose from 6.2 million in 1995 to 16.7 million, and the use of first generation prescriptions dropped from 5.2 million to 1 million.

The researchers analyzed data about the medications used over the study period, comparing information about the effectiveness of the antipsychotics widely from the drug compendium, Drugdex.

One of the problems identified with widespread use of new generation antipsychotics is the number of lawsuits that currently exist under the federal False Claims Act. Cost is another major concern, as the medications accounted for more than $10 billion in U.S. prescription drug costs in 2008 from pharmacy retailers, surpassing any other class of drugs including statins that are used to lower cholesterol.

Dr. Stafford says antipsychotic drugs have safety issues and "physicians should prescribe them only when they are sure patients will get substantial benefits."

He says patients may be unaware they're getting an antipsychotic prescription that is not even approved by the FDA. He cites the example of quetiapine, marketed under the brand name, Seroquel that is approved for schizophrenia treatment, yet commonly prescribed for anxiety and depression. The findings show there is no good evidence to support the escalating use of new, second-generation antipsychotic drugs.

Phamacoedpidemiology & Drug Safety: DOI: 10.1002/pds.2082

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