Federal regulators are warning that some older antipsychotic drugs – including Haldol, Compazine, Mellaril and Thorazine – pose a risk of deaths when they are given to elderly patients suffering from dementia.  The Food & Drug Administration (FDA) has asked the manufacturers of these antipsychotic drugs to add a black box warning – the agency’s strongest safety notice – about this danger to their labels.

The new black box warning will involve older drugs known as “conventional” antipsychotics.  Antipsychotic drugs commonly are categorized into two classes, the older “conventional” antipsychotics and the newer “atypical” antipsychotics. Both classes of drugs are dopamine receptor antagonists that work by blocking the action of naturally occurring dopamine in the brain. They differ primarily in their side effects, with the atypical drugs having a lower incidence of neurological side effects such as involuntary movements or “tics.”  The conventional antipsychotics subject to the new black box warning include:  

• Compazine (prochlorperazine)
• Haldol (haloperidol)
• Loxitane (loxapine)
• Mellaril (thioridazine)
• Moban (molindrone)
• Navane (thithixene)
• Orap (pimozide)
• Prolixin (fluphenazine)
• Stelazine (trifluoperazine)
• Thorazine (chlorpromazine)
• Tilafon (perphenazine)

The FDA decided that the new black box warning was needed after two observational epidemiological studies were published that examined the risk of death in elderly patients with dementia who were treated with conventional antipsychotic drugs. The investigators compared the risk for death with use of an atypical antipsychotic versus either no antipsychotic or the use of a conventional antipsychotic.  The agency concluded that these studies, along with the earlier evidence for atypical antipsychotic drugs, suggest that both classes of drugs should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.

Conventional and atypical  antipsychotic drugs were approved to treat the symptoms of schizophrenia.  They are not FDA -approved for use in the treatment of dementia-related symptoms, which can include forgetfulness, poor memory, and an inability to recognize familiar objects, sounds, or people. However, physicians are free to use approved drugs in any way they see fit – a practice known as off-label use.

The new black box warning for conventional antipsychotic medications indicate that they are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis. In 2005, the FDA announced similar labeling changes for atypical antipsychotic drugs. The agency has now asked the makers of both classes of antipsychotic  drugs to change labeling so that all of the drugs carry uniform warning language.

This entry was posted on Tuesday, June 17th, 2008 at 5:34 am and is filed under Legal News, Pharmaceuticals.