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Risperdal Black-Box Warning

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Risperdal carries a black-box warning to indicate the increased risk of death in elderly patients with dementia-related psychosis. This drug should not be taken by these patients.

Risperdal is an FDA-approved prescription medication for the treatment of schizophrenia, bipolar disorder and autism spectrum disorders. The drug, also known as risperidone, is an atypical antipsychotic medication that is also routinely prescribed for many other conditions. These secondary uses, known as off-label uses, mean the drug was not approved by the FDA for those conditions.

Among the more common off-label uses of Risperdal is treatment of psychosis, aggression, agitation and behavioral disorders in dementia patients. Serious health risks associated with use in elderly dementia patients prompted the FDA to require Janssen Pharmaceuticals to add a black-box warning to Risperdal labeling.

The use of Risperdal by dementia patients led the FDA to require drugmaker Janssen-Cilag, a subsidiary of Johnson & Johnson, to market the drug with a black box warning – the strictest warning possible. A black-box warning is warning information that appears on the label of a prescription medication to alert patients, caregivers and health care providers of important safety concerns associated with that medication. It is called a black-box warning because its text is surrounded by a black border.

Black-box warnings are the strictest warning that can be carried by a drug, and their appearance on drug packaging indicates that the FDA has determined that use of the drug can lead to serious side effects or death.

Risperdal’s Black-Box Warning

Risperdal’s black-box warning, issued in 2005, reads as follows:

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
RISPERDAL is not approved for use in patients with dementia-related psychosis.

According to the FDA, this warning is based on clinical evidence gathered from 17 placebo-controlled trials that enrolled 5,106 elderly individuals who suffered dementia-related behavioral disorders. Data from those trials, collected over a period of 10 weeks, showed a 4.5 percent rate of death in patients treated with Risperdal and other atypical antipsychotic drugs, compared with a 2.6 percent risk in patients taking a placebo. While causes of those deaths varied, the majority were cardiovascular deaths, heart failure or sudden death, or infectious conditions, mostly pneumonia.

If you or your loved one experienced breast enlargement after taking Risperdal or Invega, you may have legal options.

Dementia Patients at Risk

If you have a loved one who is suffering from dementia, knowing the risks and side effects of Risperdal is essential. That’s because, despite the increased risk of death noted in Risperdal’s black-box warning and its reminder that Risperdal is not approved for the purpose, this drug is still used to treat dementia-related symptoms in elderly patients.

Meanwhile, other serious risks have been associated with the use of this drug in older adults, who are more sensitive to its side effects, particularly older adults with dementia. These include:

  • Increased risk of cerebrovascular adverse events, such as stroke, mini-stroke and aneurysm.
  • Neuroleptic malignant syndrome, a life-threatening neurological disorder that can be caused by Risperdal and other atypical antipsychotic drugs.
  • Tardive dyskinesia or parkinsonism, which are syndromes that cause involuntary repetitive body movements and/or tremors.
  • Metabolic changes, including hyperglycemia, diabetes, dyslipidemia and weight gain, which can increase cardiovascular and cerebrovascular risk.
  • Increased risk of falls and fractures
  • Dysphagia, or difficulty swallowing, which can lead to aspiration pneumonia, a common problem in dementia patients.

Given the dangers that Risperdal and other atypical antipsychotic drugs pose to dementia patients and older adults in general, their widespread, off-label use in these populations is certainly a matter of concern for these patients and their families, many of whom have filed lawsuits over Risperdal injuries or deaths.

However, according to state and federal authorities, that concern was not shared by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. In August 2012, the company reached a $181 million consumer fraud settlement with 36 states and the District of Columbia over allegations that it promoted Risperdal for unapproved uses, including dementia in elderly patients, even after the black-box warning was issued. Prosecutors also accused the company of minimizing or concealing the risks of Risperdal use.