Atypical Antipsychotics Overprescribed by U.S. Doctors: Study

More than half of all prescriptions for newer, atypical antipsychotics, such as Seroquel, Zyprexa and Risperdal, are given without evidence that the powerful drugs will actually help the patient, according to new research.

A study conducted by the Stanford Prevention Research Center, which was recently published in the medical journal Pharmacoepidemiology and Drug Safety, indicates that Americans are spending billions of dollars on prescriptions for atypical antipsychotics for uses that have not been approved by the FDA, or established as safe and effective.

The lead researcher, Dr. Randall Stafford, said that the drugs should only be prescribed when doctors are sure that patients will derive substantial benefits that outweigh the potential side effects, which could include heart disease, weight gain and the risk of diabetes.

After gathering data through a survey of about 1,800 physicians, the researchers found that the prescription of antipsychotics almost tripled from 6.2 million in 1995 to 16.7 million in 2008. They also found that prescriptions of antipsychotics for uses that were not approved by the FDA went from 4.4 million prescriptions in 1995 to 9 million in 2008.

Known as off-label prescriptions, those unapproved uses generated about $6 billion for drug companies, and the researchers say $5.4 billion of that was for prescriptions that were given by doctors who lacked solid evidence that the drugs would actually help their 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 said. “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.”

Atypical antipsychotics generate more than $12 billion in sales every year, with Seroquel (quetiapine fumarate) leading the pack with nearly $4.45 billion in sales last year. A number of drug companies have gotten into legal trouble over their aggressive promotion of the drugs for a variety of uses unapproved by the FDA.

In 2009, Pfizer agreed to pay the largest criminal fine in U.S. history, $1.195 billion, to resolve claims that it illegally promoted the atypical antipsychotic Geodon, along with a number of other drugs.

In October 2010, a Louisiana jury issued a $257.7 million verdict against Johnson & Johnson for giving doctors misleading information about the risks and benefits of Risperdal. The company also faces a whistleblower lawsuit backed by the federal government that accuses it of paying kickbacks to Omnicare, a nursing home pharmacy supplier, to push the drug onto elderly patients.

In August, AstraZeneca announced that it had agreed to pay $198 million to settle 17,500 personal injury lawsuits filed by plaintiffs who allege that they suffered diabetes from side effects of Seroquel. Earlier that summer, the company told investors that it had paid about $711 million in total fighting the Seroquel lawsuits.