Though Nuedexta has never been proven safe or effective in treating the agitation that often accompanies Alzheimer’s disease or dementia, a recent CNN investigation suggests that the drug is increasingly used in nursing homes for this off-label purpose. Filing a Nuedexta lawsuit may be an option for patients who suffered serious side effects following unapproved treatment with the medication.
The drug injury lawyers at Bernstein Liebhard LLP are investigating side effects and complications that may be associated with the off-label use of Nuedexta. If someone you love suffered harm following treatment with Nuedexta, please contact our Firm today at (888) 994-5118.
Neudexta was approved to treat pseudobulbar affect (PBA) secondary to certain neurological injuries and illnesses, such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). People who suffer from PBA experience epsisodes of uncontrollable/inappropriate laughing and/or crying.
Neudexta has not been shown to be safe or effective for treating agitation or other types of emotional outbursts that can commonly occur in Alzheimer’s disease and dementia patients.
Avanir Pharmaceuticals received FDA approval to market Neudexta in 2010. Though the company’s own estimates suggest that PBA occurs in just 1% of Americans, sales of Nuedexta reached almost $300 million in 2016, with more than 14 million pills dispensed.
An investigative report broadcast by CNN in October 2017 suggested that Nuedexta’s rapidly increasing sales may have been driven by an aggressive marketing campaign that targeted elderly nursing home patients with Alzheimer’s disease and dementia.
Doctors are free to use FDA-approved drugs for any purpose they deem necessary, even for indications that haven’t been approved by the agency. However, drug makers are legally prohibited from marketing prescription medications for off-label use.
Among other things, a CNN noted that an Avanir website touts a company-funded study suggesting PBA afflicted 40% of dementia. However, experts interviewed by the network disputed that claim, maintaining that the condition occurred in fewer than 5% of patients.
Nevertheless, internal company emails reviewed by CNN indicated that Avanir’s sales reps faced intense pressure to push Nuedexta and were encouraged to directly target dementia and Alzheimer’s patients — a practice that would only be legal if these patients also had PBA.
For example, an email authored by a former Avanir regional manage bluntly urged sales reps to focus “99.9 percent” of their time on nursing home patients, and warned that devoting time to other conditions more commonly associated with PBA amounted to “diluting your chances”.
Emails from other Avanir managers indicate that the federal government’s crackdown on the use of antipsychotics in elderly nursing home patients was viewed as an opportunity for Nuedexta. Internal company documents also directed Avanir’s sales force to specifically target facilities that historically used high levels of antipsychotic drugs.
CNN also identified more than 80 cases in 19 states since 2013 where nursing homes were cited for inappropriate monitoring and use of Nuedexta, often because the patients hadn’t presented with any symptoms of PBA.
Between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services. Another $4.6 million was spent on travel and dining costs, both for speakers and for doctors being targeted by sale reps.
More than half of the Nuedexta reimbursement claims filed with Medicare in 2015 were initiated by doctors who had received money or other perks from Avanir, according to CNN.
Doctors weren’t the only Nuedexta advocates being paid by Avanir. According to CNN, at least one company-paid pharmacist appeared to suggest during a 2012 presentation that doctors could expand the use of Nuedexta when prescribing.
“I’m definitely pushing this a little bit, perhaps considered off label … but maybe it’s effective on some of the other behaviors too that we find challenging,” the pharmacist said during her Avanir-sponsored presentation. “There are certain nursing home chains, specifically in Southern California, that are saying, ‘Hey, if you have somebody with dementia that has a behavior issue, try them on Nuedexta before you put them on a psychotropic (medication.)’ It’s a little aggressive, I’ll say that. But CMS isn’t making it easy for us to use antipsychotics anymore.”
As CNN pointed out, Nuedexta has never been extensively studied in elderly patients. However, one Avanir-funded study involvinging 194 subjects with Alzheimer’s disease found that those on Nuedexta experienced falls at more than twice the rate as those on a placebo.
When the FDA was reviewing Nuedexta for approval, two key doctors on the agency’s advisory committee raised concerns about its use in Alzheimer’s disease patients, and strongly recommended that the drug only be approved for treating PBA in patients with MS or ALS. Both doctors pointed out that evidence supporting the drug’s use for other conditions was “weak,” and argued that it was unclear that PBA even existed in Alzheimer’s patients.
Despite these concerns, the FDA went on to approve Nuedexta for patients who suffer PBA due to neurological conditions like dementia.
Since 2011, Nuedexta has been listed as a suspect drug in more 1,000 adverse event reports logged with the FDA. The incidents range from rashes, dizziness and falls to comas and deaths.
Bernstein Liebhard LLP is offering free legal reviews to individuals concerned that off-label treatment with Nuedexta may have harmed an elderly loved one. To arrange for your free Nuedexta lawsuit evaluation, please call (888) 994-5118.
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