FDA Calls for Boxed Warnings on Conventional Antipsychotics

by Rajshri on  June 17, 2008 at 2:46 PM Drug News   - G J E 4
 FDA Calls for Boxed Warnings on Conventional Antipsychotics
The U.S. Food and Drug Administration has called for boxed warnings to be added on the label of "conventional" antipsychotic drugs. The FDA has said that these warnings would detail reports of increased risk of death if the drugs are used off-label to treat behavioral problems in older people with dementia.

The warnings say that if these drugs are used for dementia-related psychosis in in elderly patients they may cause death.

"It is important that health care professionals and consumers have the most up-to-date drug safety information," said Thomas Laughren, M.D., 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."

Drugs that will need to carry these warnings include Compazine (prochlorperazine), Haldol (haloperidol), Loxitane (loxapine), Mellaril (thioridazine), Moban (molindrone), Navane (thithixene), Orap (pimozide), Prolixin (fluphenazine), Stelazine (trifluoperazine), Thorazine (chlorpromazine), and Trilafon (perphenazine).

"People taking antipsychotic drugs should not abruptly stop taking them. Caregivers and patients should talk to the patient's health care professionals about any concerns," FDA advised. Currently these medicines are only approved for the treatment of schizophrenia.

Source: Medindia

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