FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs

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The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of “conventional” antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

In 2005, the FDA announced similar labeling changes for “atypical” antipsychotic drugs. At that time, Boxed Warnings, the FDA’s strongest, were added. The Boxed Warning will now be added to an older class of drugs known as “conventional” antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

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New And Improved Drugs? No Thanks, Pharma Cos Are Being Told

Antipsychotic, Big Pharma, Bipolar, FDA, Invega, News, Risperdal, Schizophrenia, Seroquel No Comments

New York psychiatrist Jeffrey Lieberman has heard Johnson & Johnson’s (JNJ) sales pitch for the new anti-schizophrenia drug Invega, but he’s not too impressed.

Problem is, Invega isn’t much different than one of J&J’s best-selling drugs, the antipsychotic Risperdal. In late June, Risperdal is scheduled to lose its U.S. patent protection, clearing the way for competing generic copies that are cheaper than Invega, which could further diminish Invega sales, already characterized as a disappointment by J&J.

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