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Off Label Risperdal Use in Nursing Homes Still Rampant

The Wall Street Journal reports that off-label antipsychotic use in nursing homes is a major concern, as the U.S. government has lobbied health care providers to curtail non-approved use of these drugs in senior patients based on a heightened risk of injury and death. The U.S. Centers for Medicare and Medicaid Services (CMS) is slated to reveal its latest figures, which show a 9 percent drop in antipsychotic use among assisted living facilities over the past two years.

The CMS had anticipated a 15 percent decrease in use of drugs like Risperdal, Abilify and Seroquel as chemical restraints, but some speculate that understaffed nursing homes rely on these antipsychotic medications as an easy fix for unruly or agitated patients, despite an FDA warning regarding Risperdal side effects on the elderly.

Black box warning about Risperdal side effects on the elderly

Manufactured by Ortho-McNeil-Janssen and Johnson & Johnson, Risperdal (generic: risperdone) is a potent antipsychotic approved for the treatment of bipolar disorders, schizophrenia and symptoms associated with autism. However, the dopamine antagonist has been widely relied upon as a sedative for elderly patients who suffer the effects of dementia. This off-label use has had deadly consequences, as Risperdal has been linked to more than 30 deaths in senior patients who were undergoing treatment for dementia. Such adverse Risperdal side effects like stroke and heart attack were known as early as 2005, when the FDA issued a warning concerning increased mortality rates in elderly patients with dementia-related psychosis.

The black box Risperdal warning – the agency’s most stringent – states that the antipsychotic significantly increases the rate of deaths in elderly patients with dementia, and that it is not indicated for such usage. Most Risperdal-related deaths were attributed to heart failure, but some were infectious (pneumonia) in nature.

Last year, Johnson & Johnson paid $181 million in Risperdal settlements based on charges that it marketed its medication to nursing homes across the country for off-label uses, even though Risperdone was not FDA-approved to treat dementia symptoms in the elderly. The massive consumer fraud settlement represents a small fraction of the controversy surrounding J&J’s deceptive marketing efforts, which have been subject of investigations and a lawsuit filed by the Department of Justice (DOJ).

Off-label Risperdal prescriptions are widespread

In its report on atypical antipsychotic abuse in American nursing homes, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) published a report stating that more than half (51 percent) of medication prescriptions such as Risperdone and Seroquel during the first half of 2007 were given to dementia patients despite documented risks for the elderly.  The report showed that out of the country’s 2.1 million elderly (age 65 or older) nursing home residents, 14 percent were given an atypical antipsychotic at least once. Even more alarming – an estimated 83 percent of those medications were administered for non-approved or off-label uses.

In addition to risks for senior patients with dementia, Risperdal has been blamed on other side effects including gynecomastia in pubescent males, sexual dysfunction, tardive dyskinesia, and Neuroleptic malignant syndrome (NMS) – a potentially fatal neurological disorder.