Nuedexta Chemical Restraint Problems Lead To Investigation By L.A. City Attorney

Avanir Pharmaceuticals is now under investigation by the Los Angeles City Attorney, following reports that it has marketed the drug Nuedexta for nursing home residents, where it is widely being used as a form of chemical restraint. 

The investigation was launched in the wake of a CNN report about Nuedexta, which is approved to treat a rare condition that causes uncontrolled emotional outbursts. However, use of Nuedexta as a chemical restraint in nursing homes appears to account for most prescriptions, where it is given to dementia patients or residents that are difficult to manage. Such use of chemical restraints is considered by many to be a form of nursing home abuse.

CNN published a follow-up story on October 19, confirming that L.A. City Attorney Mike Feuer has begun an investigation into Avanir’s practices, and is seeking any information from the public on whether the Otsuka Pharmaceuticals subsidiary broke the law with its marketing practices. Feuer will be looking into whether the company participated in kickback schemes, off-label marketing or patient privacy violations.

Since it became popular in nursing homes, Nuedexta has been linked to reports of skin reactions, dizziness, comas and death which have been filed with the FDA as adverse event reports, raising questions about the drug’s safety.

According to CNN, use of the drug jumped 400% nationwide between 2012 and 2016, when there were about 14 million prescriptions and $300 million in sales for a drug originally viewed as a “niche” treatment.

One nursing home in Los Angeles was found to have prescribed Nuedexta to one out of every four of its residents after a psychiatrist paid by Avanir came and gave a talk at the facility. At least one Ohio doctor is being investigated for receiving alleged kickbacks for prescribing Nuedexta as often as possible.

Avanir has paid out almost $14 million to health care professionals for consulting fees regarding Nuedexta, and that does not include $4.6 million in dining and travel expenses it paid out to doctors and speakers at its events, CNN reported.

Shortly after CNN’s original article, Avanir released a statement defending itself and stressing the importance of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), which was approved by the FDA in 2010 to treat pseudobulbar affect (PBA); a condition that can cause uncontrollable laughing or crying.

“We are committed to providing information on PBA and NUEDEXTA in ways that are consistent with the law and the values and expectations of the doctors and patients we serve,” the company’s statement reads. “Our promotional materials are subject to internal review and submission to FDA and Avanir’s Comprehensive Compliance Program, Code of Business Conduct and Ethics, and compliance policies reflect our commitment to an ethical culture.”

For years, concerns over chemical restraint practices have focused on antipsychotics, such as Risperdal, Zyprexa, Seroquel and others, which may pose serious risks when prescribed for “chemical restraint”.

In many cases, patients receiving these medications in nursing homes suffer from dementia, and studies have shown that antipsychotics not only provide no treatment benefits for dementia patients, but could increase their chance of dying.

The FDA has previously warned against the use of antipsychotics with dementia patients, indicating that the medications provide no benefits and may increase the risk of death. Given what is known about the potential side effects of antipsychotics, use of the medications is often considered a form of elderly abuse when the purpose is to sedate the individual, rather than treat.

In September 2014, the National Partnership to Improve Dementia Care announced that it has set a goal of reducing the use of antipsychotics in long-term care facilities. However, currently about 25% of elderly dementia patients in nursing homes throughout the U.S. are still treated with antipsychotics, even though they may not need the drugs.