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You are here: Home / NEWS . . . . . . . . / Pharmaceutical Companies / FDA regulation, and off label use of atypical antipsychotic drugs

FDA regulation, and off label use of atypical antipsychotic drugs

April 8, 2011 By Norma Leave a Comment

By Jan Henderson, PhD

Abilify, Seroquel, Zyprexa, Risperal – these are among the atypical antipsychotics for which Americans paid $10 billion in 2008. $6 billion of that was for off-label use.

The FDA only approves drugs when their safety and efficacy have been tested for specific conditions. For example, an antipsychotic might be approved for the treatment of schizophrenia. When it’s prescribed for anxiety or depression, that’s an off-label use.

After heavily marketing off-label use, the makers of Zyprexa, Seroquel, and Abilify were fined a total of $2.3 billion for their defiance of FDA regulations. For the pharmaceutical industry these days, that’s just part of the cost of doing business.

This new generation of atypical antipsychotics is much more expensive than earlier drugs, which are now available as generics. According to a new study, they are not only more expensive. They are neither safer nor more effective than their predecessors, as initially assumed. Here’s what WebMD had to say:

“Atypical agents were once thought to be safer and possibly more effective,” says study researcher G. Caleb Alexander, MD, an assistant professor in the department of medicine at the University of Chicago Hospitals. “And what we’ve learned over time is that they are not safer, and in the settings where there’s the best scientific evidence, they are no more effective.” …

“Since there were all these new drugs, and it costs 700 to 800 million to bring a drug to market, drug companies needed to make that money back,” says Jeffrey Lieberman, MD, chairman of the department of psychiatry at Columbia University, who was not involved in the study. “These drugs were marketed aggressively.”

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Filed Under: Pharmaceutical Companies, United States Tagged With: anti-psychotic drugs, off-label use, off-market advertising

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