Late last week, CNN reported on the possible inappropriate prescribing of the drug Nuedexta in nursing homes in their article, “The little red pill being pushed on the elderly.”
Nuedexta is indicated for the treatment of pseudobulbar affect (PBA), a disorder estimated to affect less than 1% of all Americans.
DailyMed provides the following information on this condition in the “Indications and Usage” section for Nuedexta:
PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.
Despite the rarity of this condition, Nuedexta is being prescribed to the elderly–particularly those in long-term care facilities–at an alarmingly high rate. This is partially due to the fact that the drug has been frequently prescribed “off-label” as a means to control agitated or aggressive elderly patients with dementia.
The possibility of nefarious motives behind these frequent (and ever increasing) prescriptions was raised in CNN’s article, and in some cases, proven. Unsurprisingly, most, if not all, of these motives were rooted in the pharmaceutical company’s desire to increase their profits.
Another distressing issue with the large number of Nuedexta prescriptions is the lack of extensive study concerning its effects in elderly patients. Only one such study has been conducted, and the results showed an increased risk of falling among patients with Alzheimer’s who were taking the drug, specifically twice that of those taking a placebo.
In addition, the recently-released FDA Adverse Events Reporting System (FAERS) Public Dashboard shows almost 300 reports concerning adverse effects classified as “serious,” meaning they resulted in either hospitalization or death.
Here is a list of some of the adverse events reported in patients using Nuedexta so far:
- Cerebrovascular events
However, it is important to note that these adverse event reports do not necessarily mean that Nuedexta has been determined to be the cause of the reported harm.
If you or a loved one are taking Nuedexta and have experienced an adverse side effect that you believe was caused by the drug, please tell us about it in the “Comments” section, below.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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