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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Psychiatrist denied license

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BY THE ENQUIRER

A judge has denied a request by a Clifton child psychiatrist to keep his license while he appeals its revocation by the State Medical Board of Ohio.

The board permanently revoked the license of Leo D’Souza, 66, after concluding he had sexual contact with patients, failed to conform to minimal standards of care and violated principles of medical ethics.

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Psychiatrists admitted to large-scale plagiarism

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Prof. Rajendra (Raj) Persaud a British consultant psychiatrist and broadcaster has admitted to large-scale plagiarism. He is being investigated by the General Medical Council for misconduct.

Now aged 45, he was once described by The Spectator as “the most eminent psychiatrist of the age.”

His career is in ruins now as the GMC began its hearings Monday. The GMC hearing in Manchester said his actions were “inappropriate” and “misleading.” The fitness to practice panel hearing has yet to decide whether his behaviour was dishonest or liable to bring the profession into disrepute.

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