A little red pill called Nuedexta is a prescription drug manufactured by Avanir Pharmaceuticals that’s been approved by the U.S. Food & Drug Administration (FDA) to treat a medical condition called PseudoBulbar Affect (PBA). It’s currently only available under the brand name Nuedexta and there are no generic equivalents.
One of the big questions since Nuedexta blasted onto the scene in 2012 is whether it’s being overprescribed to elderly people who don’t need it—and for whom it can actually be dangerous.
What is PseudoBulbar Affect?
The FDA approved Nuedexta to treat PBA.
PBA causes people with certain neurologic conditions (like Alzheimer’s disease, dementia, Parkinson’s disease, or stroke) or a brain injury to have uncontrollable incidents of exaggerated crying or laughing. And the laughing or crying doesn’t necessarily match the person’s emotional state at that moment. In other words, these emotional episodes can come on out of the blue.
Is Nuedexta used to treat anything else?
Even though the FDA has only approved Nuedexta to treat PDA, some physicians use it to treat other conditions. Because Nuedexta hasn’t been approved by the FDA for these treatments, they’re called off-label uses.
Off-label uses for Nuedexta include treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s Disease), depression, agitation in Alzheimer's disease, and irritability in autism.
What are the side effects and risks?
Like any prescription medication, there are risks of side effects with Nuedexta, and some of them are serious risks. One of the most commonly reported serious side effects is falls caused by dizziness.
This potentially dangerous medication is most commonly prescribed for elderly patients suffering from dementia who live in nursing homes or other long-term care facilities.
In my practice, I’ve heard several health care providers admit that they over-use drugs, like Nuedexta, to help quiet down, control, and manage patients who might otherwise be unruly or more difficult to deal with. On top of that, an investigation by CNN concluded that Avanir, the drug manufacturer, aggressively targeted elderly nursing home residents that may not even need the drug or for whom it may be unsafe.
Off-label use of Nuedexta may be unsafe for elderly patients diagnosed with Alzheimer’s or dementia because it causes a loss of coordination on top of the deficits that are already present with these underlying diseases. This means that doctors overprescribing this medication are doing so more for their own convenience and that of nursing home staff, while placing the patients are a dramatically increased risk of a fall. When a senior falls, it can cause broken bones, broken hips, head trauma, and even brain bleeds. These problems can be life-changing.
If you or a loved one has been seriously injured by medication mismanagement or poor nursing home care, then contact a top-rated experienced Houston, Texas medical malpractice lawyer for help in evaluating your potential case.