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City Attorney Opens Investigation Into Potential Unethical Use of Nuedexta

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On October 19, 2017, “KTLA” news announced that Los Angeles City Attorney Mike Feuer had opened an investigation into Avanir Pharmaceuticals—headquartered in California—and their marketing of their drug “Nuedexta” to nursing homes.

Nuedexta is an FDA-approved drug which treats a rare neurological condition called pseudobulbar affect or PBA. People with this condition may experience sudden and uncontrollable laughing or crying.

Yet it appears that some nursing homes are using the drug to subdue patients with dementia or Alzheimer’s disease, even though the drug may not be safe for such patients.

Did Avanir Market Nuedexta to Nursing Homes for Chemical Restraint?

When a nursing home or other care or medical facility uses medications to “control” residents, it is considered a form of abuse called “chemical restraint.” Since Congress enacted mandates as part of the Omnibus Budget Reconciliation act of 1987, nursing home residents have the legal right to “be free” from physical and chemical restraints not required to treat their medical symptoms.

According to a report from the Office of the Inspector General, Congress imposed this requirement “because of concerns about widespread use of physical and chemical restraints in nursing homes.” Examples of physical restraints include hand mitts and restrictive chairs, while examples of chemical restraints include psychoactive drugs that control mood and behavior.

Now there is concern that Avanir may have contributed to this type of abuse by aggressively marketing their drug to nursing homes. CNN reported in October that after reviewing nursing home inspection reports, they identified more than 80 cases in 19 states since 2013 where “inspectors cited nursing homes for inappropriate monitoring and use of Nuedexta—often because residents hadn’t exhibited any symptoms of PBA.”

They added that many of the cases were in Southern California, where Avanir is based “and where former employees said there has been aggressive marketing.”

Nuedexta May Be Dangerous in Elderly Patients

CNN presented more examples of possible misuse of Nuedexta, including one nursing home that placed 46 out of 162 patients on the drug after a psychiatrist at the facility—who was a paid speaker for Avanir—conducted a presentation about Nuedexta to the employees.

Since 2012, prescriptions of Nuedexta have risen by about 400 percent, with more than half going to long-term care facilities. Yet in the information that accompanies the drug, Avanir states that it has not been extensively studied in this population. In the one study they did do in patients with Alzheimer’s, those taking the drug were twice as likely to suffer from falls.

Attorney Mike Feuer stated that his office is seeking tips from the public to help determine whether Avanir broke state or federal lawsuits in their marketing tactics. Though doctors can prescribe drugs as they see fit for various conditions—in a process called “off-label” prescribing—manufacturers are allowed to advertise them only for FDA-approved illnesses and disorders.

CNN revealed that Avanir paid doctors tens of thousands of dollars to help promote the drug. The question is whether they were promoting it for off-label purposes. Avanir said in an emailed statement that PBA can be “misunderstood” by patients and their families, and that the condition often occurs in people with neurological conditions like Alzheimer’s disease and other dementias, as well as those with multiple sclerosis or ALS or “Lou Gehrig’s” disease.

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