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Study: Newer Antipsychotic Drugs Are Overused

Researchers Say Many Doctors Prescribe Drugs Despite Lack of Evidence of Effectiveness

Atypical Antipsychotics Become a Target of Lawsuits

In many cases, government regulators felt that pharmaceutical companies promoting these drugs broke the law by encouraging doctors to prescribe them “off-label.” Off-label drugs are those prescribed by doctors for purposes not approved by the FDA.

According to a report released in December 2010 by the consumer watchdog Public Citizen, some of the largest drug company settlements with the federal government in the last two decades were for the unlawful promotion of atypical antipsychotic drugs.

In 2010, for example, the drug company AstraZeneca paid $520 million to settle allegations by the federal government that it engaged in unlawful promotion of its drug Seroquel, which is the top-selling atypical antipsychotic.

AstraZeneca Responds

AstraZeneca offered the following written response to the findings of the new study:

“AstraZeneca believes that Seroquel is a safe and effective medication when used as recommended in the prescribing information and offers clinicians, patients and their loved ones an important treatment option.

Doctors need a range of options as they seek an appropriate treatment for individual patients, because they recognize a one-size-fits-all approach to treating all people with mental illnesses like bipolar disorder and schizophrenia is not possible.Doctors consider the needs of individual patients and the array of treatments that are available, including prescription medicines. Doctors are trained to carefully make these choices.

The company has worked diligently with the FDA to ensure that the safety profile of Seroquel is reflected appropriately in the prescribing information so that health care professionals can weigh the risk and benefit of Seroquel when making treatment decisions.

It is AstraZeneca’s policy to promote our medicines and to conduct interactions with healthcare professionals in compliance with the laws and regulations that govern the healthcare community in the United States. We train AstraZeneca employees to follow our compliance policies.”

Putting the Brakes on Inappropriate Use

Experts feel the overuse of these medications will need to be addressed on several fronts.

“There are several strategies that can be used to achieve more rational use of these and other psychotropic medicines, including patient and physician education, FDA empowerment, and denial of payments by public and private payers for uses that lack sufficient scientific evidence,” Alexander says.

Lieberman said more comparative effectiveness studies would help doctors better understand when drugs in the atypical antipsychotic class were superior to each other or to older drugs, and that would better inform prescribing practices.

“It’s a bit like going to the supermarket and trying to buy laundry detergent: This one has enzymes; this one has brighteners.” he says. “But we don’t really know how the drugs compare to each other.”

Many felt that the solution should not include preventing doctors from being able to prescribe drugs off-label.

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