FDA wants warnings put on antipsychotic drugs

Apr 11 2005

The Food and Drug Administration (FDA) has issued a public health advisory to health care providers, patients, and caregivers to alert them to new safety information about the use of certain unapproved or off label drugs which come under the category of “atypical antipsychotic drugs.”

The drugs were approved for the treatment of schizophrenia and mania, but recent clinical studies of these drugs used to treat behavioural disorders in elderly patients with dementia has shown a higher death rate associated with their use compared to patients receiving a placebo (sugar pill). This latest advice applies to antipsychotic drugs Abilify (aripiparozole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril (clozapine), Geodon (ziprasidone) and Symbyax, which is approved for treatment of depressive episodes associated with bipolar disorder.

The FDA wants the manufacturers of all of these kinds of drugs to add a boxed warning to their drug labelling describing this risk and add that these drugs are not approved for the treatment of behavioural symptoms in elderly patients with dementia. Such patients should have their treatment reviewed by their health care providers.

Seventeen placebo-controlled studies of four drugs in this class found that the rate of death for those elderly patients with dementia was about 1.6 to 1.7 times that of placebo. Although the causes of death were varied, most seemed to be either heart-related (such as heart failure or sudden death) or from infections (pneumonia).

These drugs fall into three classes based on their chemical structure and because the increase in mortality was seen with medications in all three chemical classes, the agency has concluded that the effect is probably related to the common pharmacologic effects of all atypical antipsychotic medications, including those that have not been studied in the dementia population.

The FDA is considering adding a warning to the labelling of older antipsychotic medications because limited data also suggest a similar increase in mortality for these drugs. The review of the data on these older drugs, however, is still on-going.