FDA Requests Warning on Older Class of Antipsychotic Drugs

Jeff Rasansky

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The U.S. Food and Drug Administration has just released a requirement for manufacturers of the older class of antipsychotic drugs to make changes to their labeling. According to the FDA, these manufacturers need to warn consumers about the increased risk of death associated with using these drugs to treat behavioral problems in the elderly.

The FDA has a warning called a “boxed warning” which is the strongest form of warning currently being used. In 2005, a similar labeling change was required for “atypical” antipsychotic drugs.

Antipsychotic drugs are categorized into two forms: the older antipsychotics and the newer “atypical” variety. Both kinds of drugs block the action of dopamine in the brain. It is generally accepted that the older antipsychotics are associated with a higher incidence of side effects.

Neither class of drugs is officially approved by the FDA for use in the treatment of dementia. The drugs are FDA-approved primarily for treating the symptoms of schizophrenia. However, physicians sometimes prescribe the antipsychotics for conditions other than those it is officially approved for. This “off-label” use is up to the discretion of the prescribing physician.

It is worth noting that people taking antipsychotic drugs should not stop taking them outright. Caregivers and patients should talk to the appropriate health care professionals with any concerns. See the official FDA release for a list of atypical and typical antipsychotics.