Risperdal Black Box Warning

Risperdal (risperidone) is an “atypical” antipsychotic approved to treat schizophrenia and bipolar disorder in adults and children and autism in children. In addition to other side effects, the medication has been shown to pose a serious risk to elderly patients with dementia which prompted the FDA to require a “black box warning” on the prescribing information for Risperdal.

Quick Summary
Risperdal Use in the Elderly

Risperdal is approved to treat schizophrenia, bipolar disorder, and behavioral symptoms associated with autism and is used in both children and adults. It has been used “off-label” for other conditions including agitation in Alzheimer’s patients and elderly dementia patients and criticized when used as a “pharmaceutical restraint”.

Patients with dementia who are given Risperdal may be more likely to die from cardiac failure, pneumonia and cerebrovascular events (stroke), possibly because they are unable to report medical symptoms.

Risperdal Black Box Warning

Risperdal has been associated with increased risk of death in elderly dementia patients. Patients over the age of 65, who also have dementia may be 1.6 to 1.7 times more likely to die while taking Risperdal.

Janssen warned Canadian doctors about Risperdal risks in the elderly in 2002 but did not issue a similar warning to U.S. physicians until the following year. In 2005, based in results from 17 different studies, the FDA required a black box warning regarding use in elderly dementia patients be included in prescribing information.

In addition to increased death risk, the warning states that the drug is not approved to use in elderly patients with dementia-related psychosis.

Risperdal Black Box Warning

Risperdal (risperidone) is an “atypical” antipsychotic approved to treat schizophrenia and bipolar disorder in adults and children and autism in children. It was approved by the food and Drug Administration (FDA) in 1993 and is manufactured by Janssen, a division of Johnson & Johnson, the largest pharmaceutical and medical products company in the world.

In addition to the approved uses, Risperdal has been used for “off-label” indications which were not approved by the FDA. One of the common unapproved uses for Risperdal has been the treatment of behavioral disorders such as psychotic episodes, aggression, and agitation in patients with dementia which may increase the risk of death.

In addition to the many side effects of Risperdal, the medication has been shown to pose a serious risk to elderly patients with dementia. These health risks prompted the FDA to require a “black box warning” on the prescribing information for Risperdal.

Black Box Warning on Risperdal

A black-box warning or boxed statement is the most severe warning that a medication can receive from the FDA. It is placed at the top of prescribing information in a box with a thick black border so that health care professionals will see the warning before prescribing the medication. 

The black box warning on prescribing information for Risperdal was required by the FDA to be added to medication labelling in September of 2006. A clear statement regarding the dangers of administering Risperdal to elderly patients in the black box indicates that the medication poses an increased risk of death.

Risperdal Use in the Elderly

Risperdal’s black box warning was prompted by a review of 17 placebo-controlled studies with 5,106 elderly patients on antipsychotics over a period of about 10 weeks. Study results showed that elderly patients who took Risperdal had a risk of death that was 1.7 times higher than those who took placebo. The specific causes of death varied from patient to patient but were primarily related to cardiovascular causes such as heart failure or heart attack and infections such as pneumonia.

Though the exact cause of increased risk is unknown, some experts have suggested that it may be caused by an inability of elderly patients with dementia to communicate or report difficulty breathing or other symptoms which may indicate complications.

The black box warning on Risperdal outlines the increased risk of mortality (death) in elderly patients with dementia and states that Risperdal is not approved to treat these patients. Risperdal’s black box warning appears as:

Risperdal Off-label Use

Medications may be used for off-label reasons when a physician feels that the drug may be beneficial, however pharmaceutical companies are prohibited from marketing medications for unapproved indications or off-label use.

Despite the FDA black box warning, lack of approval, and the clear risks, Risperdal continues to be used as off-label treatment for elderly patients with dementia. Risperdal is known to have a calming effect on agitation, psychotic episodes, and violent behavior.

Janssen, the subsidiary of Johnson & Johnson was ordered to pay $181 million in fines to 26 states and the District of Columbia as a penalty settlement for illegal marketing of Risperdal including promoting the medication for elderly patients with dementia. The companies have also paid $billions in other fines and settlements for fraud, illegal marketing and medical injuries and is still facing thousands of lawsuits.