The risk of risperdal and stroke in patients with dementia-related psychosis is serious enough to warrant a black box label. Risperdal has not be shown to be a safe or effective treatment of patients with dementia-related psychosis.

In a letter to healthcare providers dated April 2003, Janssen Pharmaceuticals, the maker of risperidone, described adverse event reports that prompted the label revision: "Cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities, were reported in patients in trials of risperidone in elderly patients with dementia-related psychosis." The controversial aspect of this Risperdal stroke announcement was the fact that Johnson & Johnson had already issued a Canadian Risperdal stroke letter in October 2002. The Canadian Risperdal stroke warnings cited 37 reports of Risperdal stroke or Risperdal stroke-like events, including 16 deaths. Physicians in the United States were not warned until another 5 months had passed.

In addition, a significantly higher incidence of cerebrovascular adverse events was seen in patients treated with Risperdal compared with those treated with placebo. This label update was based on data from a study of 1,230 patients with dementia in four placebo-controlled trials conducted in elderly patients with dementia. Janssen emphasized in the letter that Risperdal is not indicated for the treatment of dementia.

The implications that Risperdal stroke occurrences are more likely to occur should result in a higher accountability for prescribing Risperdal.

Many patients are concerned that Johnson and Johnson is not promptly warning the FDA and/or their physicians of serious events such as Risperdal strokes over concerns that safety warnings will hurt sales.

The result of a Risperdal stroke can affect the entire body. Depending on the severity of the Risperdal stroke paralysis, cognitive effects, emotional problems, speech difficulties, loss of mobility, in addition to other adverse effects could be suffered. If you or a loved one has taken Risperdal and have suffered a Risperdal stroke or any other Risperdal side effect, then please contact our attorneys who can assist you with asserting your legal rights and seeking recovery for the injuries you have suffered.

For more information: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm152291.htm

Labels: Black box label, Canada, dementia, Risperdal, Stoke, stroke