Drugmaker Under Investigation for Going Off-label with Anti-psychotic Drug

A recent report by CNN revealed the lengths to which one California drug maker may be going to push sales of Nuedexta, a little red pill developed to treat certain behavioral problems but has been increasingly used in nursing homes to control residents. The story by CNN was so compelling that the City Attorney for Los Angeles even opened an investigation into the drug maker’s targeting of nursing home residents.


The Food and Drug Administration (FDA) approved Nuedexta to treat a disorder marked by sudden and uncontrollable laughing or crying, known as pseudobulbar affect (PBA). According to maker Avanir Pharmaceuticals’ own data, less than 1 percent of American’s suffer from the condition and is most commonly associated with patients suffering from multiple sclerosis (MS) or ALS (Lou Gehrig’s disease).


Unfortunately, Avanir appears to paying doctors to push the medication onto nursing home workers as a way to control the behavior of unruly residents, something the drug is not approved for nor studied enough to warrant such applications. CNN reports suggest some doctors even took in tens of thousands of dollars in exchange for speaking engagements and other talks on the benefits of using the drug for “off label” applications.


One possible danger of prescribing Nuedexta to patients with neurological disorders may include the increased risk of fall. The drug maker’s own data in one study on 194 alzheimer’s patients suggests patients on Nuedexta fell at a rate twice as high as those on placebo. Simply put, the drug shows little or no benefit so far to helping dementia patients manage their symptoms in a safe manner.


CNN identified dozens of cases where nursing homes across the country appeared to have improperly prescribed Nuedexta for behavior issues unrelated to treating PBA. At one nursing home alone, one-quarter of the residents were on Nuedexta. If true, the reports show a disturbing trend among nursing homes across the country looking to “manage” residents rather than provide the proper care necessary to live a comfortable and dignified life.


CNN reports that since approval, the FDA lists Nuedexta as a possible cause in over 100 hospitalizations and over 50 deaths. Like many signs of nursing home abuse, recognizing the signs of overmedication can be difficult but there are some side effects of PBA family members should look out for. Those side effects include rashes, dizziness, and bruises from falls.

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