A new “little red pill” with possible negative side effects is gaining steam in long-term care facilities that treat dementia patients, a CNN investigation has found.
The pill, Nuedexta, is approved by the Food and Drug Administration (FDA) to treat a disorder referred to as Pseudobulbar affect (PBA), which is known to cause fits of laughter or crying. Just 1% of the U.S. population has PBA, and it’s rare among people living with dementia, experts told CNN.
Long-term care providers such as skilled nursing facilities (SNFs) are increasingly turning to Nuedexta to treat dementia patients, especially as they seek to reduce anti-psychotic medication use to comply with federal guidelines, according to CNN. More than half of all Nuedexta pills have gone to long-term care facilities since 2012, and last year, Nuedexta’s sales hit nearly $300 million.
From the CNN investigation:
“Nuedexta is being increasingly prescribed in nursing homes even though drugmaker Avanir Pharmaceuticals acknowledges in prescribing information that the drug has not been extensively studied in elderly patients — prompting critics to liken its use to an uncontrolled experiment. The one study the company conducted solely on patients with Alzheimer’s (a type of dementia) had 194 subjects and found that those on Nuedexta experienced falls at more than twice the rate as those on a placebo.”
Paid advocates for the drug told CNN that PBA can manifest itself in other ways than crying or laughing, and Avanir said the disorder can afflict up to 40% of people with dementia.
But nursing home inspectors questioned the use of Nuedexta in “dozens of cases across the country since 2013,” CNN found.
The reason for that questioning might have something to do with the drug’s side effects. When Nuedexta hit the market in 2011, doctors, nurses and family members of patients began reporting to the FDA symptoms such as rashes, dizziness, falls, comas and even death.
Though these symptoms may have nothing to do with that drug, prescribing yet another pill to an already medicated Alzheimer’s or dementia patient could cause unintended problems, Lon Schneider, director of the University of Southern California’s Alzheimer’s Disease Center, told CNN.
Written by Tim Regan