Nuedexta, comprised of dextromethorphan and quinidine, is a prescription medication most commonly used to treat involuntary laughing or crying outbursts associated with conditions like multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS/Lou Gehrig’s disease). Pseudobulbar affect (PBA) is the medical term for these outbursts. While Nuedexta is approved by the U.S. Food and Drug Administration (FDA) to treat PBA, new evidence suggests inappropriate prescribing may be the cause of hundreds of adverse event complaints, including Nuedexta falls.
Affecting less than one percent of all Americans, PBA is primarily associated with conditions like ALS or MS. Medical experts and researchers have stated that PBA is “extremely rare” in patients with dementia. Still, doctors have had the discretion to prescribe Nuedexta to elderly patients regardless of the associated risks.
How Nuedexta Works
Nuedexta treats PBA by targeting specific parts of the brain. According to the Nuedexta website, exactly how the drug works is not know. Dextromethorphan is an ingredient commonly found in over-the- counter and prescription cough medication, and is known to signal the cough reflexes in the brain. Quinidine is known to affect the heart beat, and is most commonly used to treat individuals with certain heart rhythm disorders.
Nuedexta was approved by the FDA in 2011. Since 2012, over half of all Nuedexta pills manufactured have gone to long-term care facilities. The number of pills manufactured has also increased 400 percent in just four years.
Questions over the safety and efficacy of Nuedexta date back to the FDA approval process when two committee members warned that evidence suggesting Nuedexta was effective in treating disorders outside PBA was “weak”. Despite the risks and warnings, the FDA approved the drug, and was promptly met with an outpouring of complaints about adverse side effects.
Currently, the list of possible side effects of taking Nuedexta is lengthy, including:
- Nuedexta falls
- Gas, diarrhea, or vomiting
- Easy bruising or bleeding
- Headache accompanied by chest pain, dizziness, or fainting
- Fluttering, fast, or pounding heartbeats
- Flu-like symptoms
- Liver problems (upper stomach pain, fatigue, loss of appetite, jaundice, etc.)
- High serotonin levels (hallucinations, fever, agitation, loss of coordination, fainting, etc.)
It is noted that older adults are more likely to suffer from side effects like confusion, constipation, and dry mouth. Nuedexta has been FDA approved to treat patients with PBA, including elderly patients also suffering from psychiatric conditions like dementia, even though research is extremely limited about whether it is really safe or effective.
Another warning related to Nuedexta is the fact that it is contraindicated with many medications commonly prescribed, including antibiotics, MAOI inhibitors, antidepressants, blood pressure and heart medication, antifungal medications, and certain medications used to treat cancer. The Director of the University of Southern California’s California Alzheimer’s Disease Center warns that there are potentially dangerous interactions between Nuedexta and many of the medications commonly prescribed to elderly patients.
Nuedexta Complaints and Lawsuits
With so much controversy, and a flood of adverse event reports, researchers have initiated numerous studies to address the safety and efficacy of Nuedexta. CNN also launched an investigation aimed at raising awareness of the dangers of Nuedexta and the unethical way in which the drug has been managed by the manufacturer and some doctors. According to the CNN analysis, almost half of Nuedexta claims filed with Medicare were filed by doctors who had been compensated by Avanir, either via payments or meals.
As for the safety and efficacy in the elderly population, one recent study focused on 194 patients with Alzheimer’s and found that patients taking Nuedexta suffered from falls at greater than twice the rate of those taking a placebo. Perhaps not surprisingly, since 2011, hundreds of complaints have been filed with the FDA, with many reporting dizziness, confusion, and Nuedexta falls.
As questions of safety and effectiveness linger, so do questions about the ethics of using Nuedexta in patients with dementia. For many years, medications operating like chemical restraints (antipsychotics) have been frowned up or even banned from use. Now, there are questions about whether Nuedexta is being inappropriately prescribed as an alternative to such medications, especially among patients suffering from outbursts or unruly behavior.
So far, Nuedexta has been linked to 113 hospitalizations, 51 deaths, 102 adverse sedation and sleepiness events, and 101 adverse dizziness, confusion, or fall reports. Looking ahead, there is a great need for more clinical trials and studies to determine exactly what the risks and benefits of Nuedexta are among patients with dementia. Nuedexta has only been FDA approved in patients with PBA regardless of any comorbid conditions.
Further research is also needed to determine if healthcare providers are inappropriately diagnosing PBA and prescribing Nuedexta for other reasons as research suggests may be the case.
For more information about medications linked to medical malpractice or nursing home abuse, contact MedMalFirm.com today.