The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

When the FDA approves drugs for the market, they approve them to treat one or more specific conditions.  The drug manufacturers can legally advertise the drugs only for those approved conditions. Doctors, however, may prescribe those drugs to treat other conditions, in a practice referred to as “off-label” use.

That’s what a number of doctors are doing with Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), which is FDA-approved to treat pseudobulbar affect, or PBA. PBA is a condition that can occur in people with neurological conditions, and causes sudden uncontrollable and inappropriate laughing or crying.

Recent reports, however, show that doctors may be prescribing Nuedexta for another reason—to treat nursing home residents with dementia and Alzheimer’s disease—often in return for payments from the company. According to an October 2017 CNN report, the drug may be unnecessary in this population, and perhaps even unsafe.

Are Nursing Home Doctors Over-Prescribing Nuedexta?

According to CNN, more than half of all Nuedexta pills have gone to long-term care facilities since 2012, with the number of pills distributed jumping by 400 percent between 2012 and 2016. Its manufacturer, Avanir, has paid out nearly $14 million to doctors and other healthcare professionals for consulting and promotional speaking fees related to the drug.

A CNN analysis also showed that almost half of Nuedexta claims filed with Medicare in 2015 “came from doctors who had received money or other perks from the company (ranging from a few dollars’ worth of food or drink to hundreds of thousands of dollars in direct payments).” It is legal for companies to pay a doctor to promote a drug to colleagues, but it’s illegal to pay them kickbacks for prescribing the drug.

The concern is that prescribing Nuedexta may be unsafe for many nursing home residents. Avanir conducted one study on patients with Alzheimer’s disease, and found that those on Nuedexta were twice as likely to fall as those taking a placebo. Falls in the elderly population are extremely dangerous, and in some cases deadly.

Are Nursing Home Doctors Using Nuedexta to Make Patients Easier to Manage?

Regulators have found that doctors may be diagnosing nursing home patients with PBA when they may not have it, simply so they can prescribe them the drug.

According to the CNN report, there is evidence that the drug is being used in patients who are unruly or difficult to manage. CNN found several cases where Nuedexta was prescribed simply to calm patients. In a Southern California facility, for example, inspectors found a resident was diagnosed with PBA simply so staff members could control the resident’s outbursts.

Doctors that prescribe the medication off-label say that it helps patients and that PBA can be present even without the typical symptoms. Yet the FDA has received about 1,000 adverse event reports related to the drug, in which patients suffered from side effects like rashes, dizziness, and falls leading to coma and death.

Avanir Under Investigation for Potential Unlawful Marketing

There is evidence, including internal company communications that suggests Avanir is aggressively targeting nursing homes and other similar facilities in their marketing campaigns. After reports of Nuedexta misuse in California, Los Angeles City Attorney Mike Feuer launched an investigation into Avanir’s marketing campaigns, to see if the company has broken any laws.

“If there is a possibility they [the nursing home residents] 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,” he told KTLA News.

Meanwhile, CNN has identified more than 80 cases in 19 states “where inspectors cited nursing homes for inappropriate monitoring and use of Nuedexta—often because residents hadn’t exhibited any symptoms of PBA.”

Comments are closed.

Of Interest