Newer antipsychotic drugs often prescribed for non-FDA approved uses

Researchers on a new study published in Pharmacoepidemiology & Drug Safety journal have concluded that new generation (a.k.a. “atypical") antipsychotic medications are overprescribed in the U.S., and lack evidence that the drugs actually help many conditions for which they are prescribed.

For the study, researchers at the Stanford University School of Medicine and University of Chicago used data from the IMS Health National Disease and Therapeutic Index. They collected data on the number of treatment visits using atypical antipsychotics, and also determined the number of uses that did not fit with the U.S. Food and Drug Administration guidelines for antipsychotic use.

This new generation of antipsychotic drugs initially hit the U.S. market in 1989, and were mainly used to treat schizophrenia, a use approved by the FDA. Today, researchers say that the drugs are more often used for conditions such as autism, bipolar disorder, delirium, dementia, depression and personality disorders, as well as for other psychoses. Some of these uses have been approved by the FDA, but many have not.

Researchers determined that use of antipsychotics increased from 6.2 million treatment visits in 1995 to 16.7 million visits in 2006. Then, there was a decline indicated, with treatment visits numbering 14.3 million by 2008. However, overall antipsychotic use that did not fit U.S. Food and Drug Administration guidelines increased from 4.4 million treatment visits in 1995 to 9.0 million in 2008.

These findings are important because these drugs can have serious side effects, researchers indicated, such as weight gain, diabetes, and heart disease. Additionally, the drugs are extremely costly. Researchers indicated that the estimated cost of atypical antipsychotic drugs in 2008 was more than $10 billion, the largest for any single drug class, and almost five percent of all drug spending. These drugs include quetiapine, aripoprazole (brand name, Abilify), olanzapine (Zyprexa) and risperidone (Risperdal).

“Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits,” said Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, and senior author of the study.

Prescribing drugs for reasons other than recommended FDA use, called “off-label” use, is not uncommon, nor is it illegal, Stafford indicated. At times, it can even be helpful, especially if a patient has not responded well to traditional treatments. Still, in 2005, the FDA issued a “black box” warning for new-generation antipsychotics, because of an increased risk of death for 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,” said Stafford. In fact, of the $10+ billion spent on antipsychotic medication in 2008, approximately $6 billion was for off-label use. And, patients may be surprised to learn that their doctor may not even realize that the prescription he writes is not an FDA-approved use. “In many cases, physicians don’t realize they’re prescribing off-label,” Stafford said.

Stafford suggested that marketing is the main reason for the increase in antipsychotic prescriptions, whether their use is justified or not. “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,” he said.

Yet, researchers indicated that “all major companies selling new-generation antipsychotics have either recently settled cases for hundreds of millions of dollars or are currently under investigation for skewing results or using questionable marketing tactics.” In fact, they said that this new generation of antipsychotic drugs is currently “the single largest target of litigation filed under the federal False Claims Act."

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