Antipsychotic drug linked to dangerous side effects

Antipsychotic drug linked to dangerous side effects – Brief Article

On April 16, 2003, Janssen Pharmaceutica, Inc., announced that its antipsychotic drug Risperdal (risperidone) might cause stroke or transient ischemic attack (a temporary reduction of blood flow to the head), among other adverse cerebrovascular effects. The warnings were added to the package insert for the drug after the effects were reported in older patients who were taking Risperdal[R] for dementia.

The Food and Drug Administration (FDA) has not approved the drug for treatment of dementia; its only approved use is for the treatment of schizophrenia. Such “off-label” uses can cause unexpected adverse effects in patients who would otherwise not be expected to take the drug.

The company’s warning about Risperdal[R] came after a controlled clinical trial involving more than 1,200 patients with Alzheimer’s disease or vascular dementia. Cerebrovascular events were reported in 4 percent of the patients. On October 11, 2002, a warning was sent to Canadian health care professionals about the adverse of effects of Risperdal[R], six months before Americans were warned. The Canadian authorities stated that, worldwide, 37 cases of cerebrovascular effects had been associated with the use of the medication.

The FDA estimates that only from 1 to 10 percent of adverse effects are reported because of (1) the voluntary nature of the reporting system and (2) the lack of laws and regulations regarding the documenting of serious adverse effects.

(Source: Worst Pills, Best Pills News, June 2003.)

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