The City Attorney for Los Angeles has launched a new investigation, following broadcast of a CNN report detailing the rising use of Nuedexta among elderly nursing home patients, especially in Southern California.
According to the cable network, Mark Feuer is seeking information and tips from the public to determine if California-based Avanir Pharmaceuticals broke any laws in aggressively marketing Nuedexta to treat elderly people with Alzheimer’s disease or dementia.
“Those to whom this medication is being administered are as vulnerable as anyone can be. They rely on other people to make decisions for them,” Feuer told CNN. “If there is a possibility they are being administered a medication not because it is in their best interest, but because it is in the financial interest of, say, the drug manufacturer, then it is important for us to intervene.”
Feuer said he is interested in potential patient privacy violations, kickbacks paid to doctors and off-label marketing.
Nuedexta is only approved to treat pseudobulbar affect (PBA), a rare condition marked by inappropriate outbursts that occurs secondary to other neurological illnesses or injuries, such as multiple sclerosis.
Avanir’s own estimates indicate that PBA occurs in just 1% of Americans. Though the company contends that up to 39% of dementia patients suffer from the disorder, experts interviewed by CNN disputed that figure, placing the rate at less than 5%.
Nuedexta has not been systematically tested in the elderly and it has not been shown to be safe and effective in treating other types of emotional lability that can commonly occur with Alzheimer’s disease and dementia.
The number of Nuedexta pills manufactured by Avanir grew 400% between 2012 and 2016. More than half of those pills were distributed to long-term care facilities.
The CNN report uncovered more than 80 instances in 19 states where nursing homes were cited for inappropriate use of Nuedexta. A significant number of these cases – 40% – were found in Southern California.
Among other things, inspectors uncovered instances of doctors inappropriately diagnosing nursing home residents with PBA to justify using Nuedexta in patients who merely suffered from dementia-related confusion, agitation and unruly behavior.
Some of the doctors had been paid tens of thousands of dollars by Avanir to promote the drug.
“There is little to no medical literature to support the drug’s use in nursing home residents [with dementia] — the population apparently being targeted,” Kathryn Locatell, M.D., a physician who assists the California Department of Justice in nursing home abuse cases, told CNN.
While physicians are permitted to prescribe medications for any purpose they deem appropriate, it is unlawful for drug makers to promote their products for off-label indications that have not been approved by the U.S. Food & Drug Administration.