Safety Alerts & Recalls

What does this mean?

Antipsychotic drugs are commonly divided into two groups, the older "conventional" antipsychotics and the newer "atypical" antipsychotics. Both classes are primarily approved by the FDA for the treatment of schizophrenia, and are sometimes used "off label" for the treatment of behavioral problems in older people with dementia. Today's alert adds the same black box warning to "conventional" antipsychotics as was added to "atypical" antipsychotics in 2005.

If you are using, or caring for someone that uses trifluoperazine for treatment of dementia related behavioral problems, today's alert is simply a reminder that you and your doctor should periodically review the benefits versus risks of this medication.

New Boxed Warning on Older Class of Antipsychotic Drugs

Today's alert relates to a potential increased risk of death when "conventional" antipsychotics are used in older people with dementia.

The U.S. Food and Drug Administration announced that it will now require manufacturers of "conventional" antipsychotic drugs, (such as trifluoperazine) 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.

For More Information: more information here

Source: FDA
Publication Date: 2008-06-17
Last Updated: 2009-12-06

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