Risperdal Black Box Warning

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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 2007, sales of Risperdal topped $4.5 billion per year.  After the drug became available generically, Risperdal sales continue to exceed $1.5 million per year.  A similar drug, Invega (paloperidone), also manufactured by Johnson & Johnson has sales of approximately $1.8 billion per year.

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

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.

A black-box warning is the most severe warning that a medication can receive.  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.  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.

Black Box Warning on Risperdal

The black box warning on prescribing information for Risperdal was required by the FDA to be added to by September of 2006.

The 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.

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 black box 1risperdal black box 2

Risperdal and Use in the Elderly

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.

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.

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.

Other Risperdal Warnings

In addition to the increased risk of death in the elderly, Risperdal has additional warnings associated with risk of side effects which can be severe and debilitating or life-changing.

Extrapyramidal Side Effects

Risperdal has a number of side effects which cause movement disorders, some of which may be permanent or even life threatening.

Tardive Dyskinesia is the development of abnormal facial, shoulder and limb movements which the patient cannot control.  Once tardive dyskinesia develops, it generally requires treatment with a medication to manage the side effects and will usually not go away after the medication has been discontinued.  Tardive dyskinesia is more common in the elderly, particularly in women.

Neuroleptic Malignant Syndrome is a potentially fatal reaction to antipsychotics such as Risperdal.  It causes muscle rigidity, high uncontrollable fever, irregular blood pressure, and irregular heart rhythm.  It is considered a medical emergency and is often fatal.

Other Movement Disorders and side effects associate with Risperdal have a negative impact on a patient’s quality of life and may pose additional risks such as:

  • Sedation, Fatigue, Blurry vision and Dizziness leading to increased fall risk
  • Increased saliva production, Difficulty swallowing (dysphagia) and Stiffened tongue (torticollis) leading to increased risk of aspiration pneumonia and difficulty breathing
  • Anxiety, Restlessness and Tremor

In addition to the warnings and side effects, Risperdal may interact with other medications and cause harm.  Patients should report all of their medication use and any side effects to their health care provider.

View Sources

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