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FDA requests warnings on antipsychotic drugs

The FDA has issued a requirement for manufacturers of older class, "conventional" antipsychotic drugs to include safety warnings
The FDA has issued a requirement for manufacturers of older class, "conventional" antipsychotic drugs to include safety warnings in prescribing information or labelling.

In 2005, similar labelling restrictions were imposed on the newer, "atypical" antipsychotic drugs. Both classes of drugs will now carry boxed warnings (the FDA's strongest) that clinical studies show an increased risk of death when used to treat dementia in elderly patients.

In the US, it is common for doctors to prescribe drugs to treat an illness other than the indication for which it was approved by the FDA.  Both older, "conventional," and newer, "atypical" antipsychotic drugs that are licensed for the treatment of symptoms associated with schizophrenia, are frequently prescribed to treat dementia-related symptoms.

"It is important that health care professionals and consumers have the most up-to-date drug safety information," said Dr Thomas Laughren, director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research. "The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia."

Letters issued under the Food and Drug Administration Amendments Act of 2007 (FDAAA) have been sent to manufacturers of these drugs. Drugs companies will have 30 days to submit wording for new labelling to the FDA or to present an argument against why the changes are necessary.

17th June 2008


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