In October 2017, CNN concluded an investigation into the use of drug Nuedexta in nursing homes. On the heels of numerous reports, here is a compilation of some of the most commonly asked questions about Nuedexta in nursing homes.
What is Nuedexta Used For?
Nuedexta is a drug manufactured by Avanir Pharmaceuticals containing dextromethorphan and quinidine. It is approved by the U.S. Food and Drug Administration (FDA) to treat uncontrollable crying or laughing outbursts, known as pseudobulbar affect (PBA). PBA is most commonly associated with disorders like multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS/Lou Gehrig’s disease).
Consider the following facts and figures about PBA and Nuedexta in nursing homes:
- Pseudobulbar affect (PBA) affects less than one percent of the population.
- Since 2012, Nuedexta sales have increased 400 percent.
- PBA affects less than 5 percent of individuals with dementia.
- More than 50 percent of all Nuedexta pills manufactured are distributed to patients in nursing homes, which accounts for approximately 14 million pills.
- Nuedexta has not been extensively tested or studied for use in elderly patients or those with dementia.
Why is Nuedexta Prescribed in Nursing Homes?
The answer to this question is, no doubt, shrouded in one of the many possibilities that ongoing investigations and research are highlighting. There are several schools of thought on why Nuedexta is so commonly prescribed in nursing homes, such as:
- Nuedexta may be viewed as a safer alternative to controversial chemical restraints and sedatives. Nuedexta may be prescribed as a means of helping long-term care facilities manage difficult behaviors among patients with Alzheimer’s or dementia. Some state regulators have found that Nuedexta was being inappropriately prescribed to nursing home patients, with PBA being diagnosed as a justification for using medication to treat difficult, confused, or unruly behavior.
- There are many people who believe that financial factors have led doctors to overprescribe or inappropriately prescribe Nuedexta to elderly patients. The CNN investigation discovered multiple accounts of doctors receiving financial “perks” or compensation in exchange for their support or endorsement of Nuedexta. Many of those doctors have since been discovered to have numerous (even hundreds) of patients taking Nuedexta.
- There is also concern that Avanir Pharmaceuticals may view long-term care facilities as “easy targets” for their marketing. Since 2012, sales of Nuedexta have sky-rocketed almost 400 percent, with sales reaching $300 million in 2016. Aggressive marketing tactics focused on elderly patients and those with Alzheimer’s and dementia are considered factors.
Is Nuedexta Suitable for Elderly Patients?
With so many elderly patients prescribed Nuedexta, on the surface it would seem that it is certainly appropriate for use in said patients. Unfortunately, that is not the case with Nuedexta in nursing homes. Nuedexta has only been FDA approved to treat patients with PBA. It has not been approved, or extensively tested, for use in patients without PBA, regardless of underlying conditions such as Alzheimer’s or dementia.
Studies that have been conducted on patients with Alzheimer’s indicated that Nuedexta users experienced falls at greater than twice the rate of their placebo-taking counterparts. With elderly patients, and especially those with Alzheimer’s or dementia, already being predisposed to falls and injuries, medications that double the risk certainly cause concern among advocates, caregivers, and family members.
The applicability and effectiveness of Nuedexta for nursing home residents is also a concern to many attorneys. At Brown, Christie & Green, our passion is protecting nursing home residents. If you have questions about Nuedexta and whether your loved one has been inappropriately prescribed this or any other medication, contact us today.
Is Nuedexta Dangerous?
Unfortunately, there is no clear answer to this question, but increasing research suggests the answer is “yes!”. Studies have shown that Nuedexta increases fall risk, but similar research is extremely limited. When Nuedexta was approved by the FDA, clinical trials leading up to approval only included patients with MS or ALS. PBA can occur with MS, ALS, or other neurological conditions (including stroke or dementia), but it is not FDA approved for all of these conditions.
Dr. Eric Widera, who specializes in geriatrics and is a professor at the University of California San Francisco (UCSF) noted that an increased fall risk among patients with Alzheimer’s is a life-threatening problem. Since Nuedexta was approved and entered the market, thousands of complaints were filed with the FDA citing dizziness, falls, rashes, coma, and even death. Nuedexta was cited as a “suspect” in at least 1,000 of those complaints.
In addition to the fall risk, Nuedexta is also contraindicated with many medications, with reactions potentially causing serious side effects for patients. In fact, interactions may occur with Nuedexta and over-the-counter (OTC) medications, vitamins or supplements, or other prescription medications. Some of the medications that are known to adversely react with Nuedexta include:
- Antibiotics: Erythromycin, Clarithromycin, Azithromycin, Pentamidine
- Antifungal: Fluconazole, Ketoconazole
- Cancer Medications: Vandetanib, arsenic trioxide
- Anti-Depression/Mental Illness Medication: Pimozide, Citalopram, Nefazodone, Ziprasidone
- Heart/Blood Pressure Medication: Sotalol, Disopyramide, Diltiazem, Verapamil
Drug interactions are another serious concern among elderly patients. Elderly individuals often require a variety of regular medications. Nuedexta may interfere with many of these medications making it very dangerous.
Learning More and Protecting Your Loved Ones
There is no doubt that Nuedexta is not right for everyone. Ongoing research and investigations will help provide clearer answers to the issues we have addressed in this post. In the meantime, ensure that your love one’s legal rights are protected by contacting Brown, Christie & Green. We can help you explore your concerns about Nuedexta in nursing homes and find answers to your individual situation and ensure that your loved one gets the protection and justice that he or she deserves. Fill out our online form to get started.