A new pill with old ingredients is being pushed to nursing homes and their patients, despite documented reports of side effects ranging from dizziness and falls to death. The medication is Nuedexta from Avanir Pharmaceuticals, Inc. Nursing homes often call it “The Little Red Pill.” Some doctors appear to be illegally profiting from Nuedexta, and tax dollars are frequently paying for it.
What is Nuedexta?
Nuedexta combines two old, well-known drugs: dextromethorphan and quinidine. If you’ve ever taken over-the-counter cough syrup, you’ve likely taken dextromethorphan, a cough suppressant. Quinidine is less commonly taken; doctors prescribe it to treat certain types of heart arrhythmias (irregular beats) and, in some cases, malaria. When you combine the two, the result is a drug that is effective in combating pseudobulbar affect (PBA), characterized by uncontrollable crying or laughing. Persons diagnosed with multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, can suffer from PBA, which is found in less than one percent of the U.S. population.
Why Use Nuedexta?
Because Nuedexta has a psychotropic effect, nursing homes find it useful to control certain behaviors of those with Alzheimer’s disease or other dementia disorders. Patients with dementia often need additional hours of nursing care. Previously, the solution was either to hire more staff or choose not to provide sufficient care for the patient. When a drug is used, patients are quieter and the cost to the nursing home is much smaller, because Medicare Part D picks up some of the costs. Drugs cost less than extra staff.
An Avanir website claims PBA is a problem for 40 percent of dementia patients. But doctors who specialize in treating the elderly and dementia researchers say that PBA is actually quite rare in dementia patients, affecting at most 5 percent of them.
The clinical trials required for FDA approval were done only with MS or ALS sufferers, and not those with Alzheimer’s disease or other dementia disorders. In fact, the drug has not been well-studied for use in the elderly. Avanir conducted only one double-blind study, with 194 Alzheimer’s patients, and discovered that those taking Nuedexta suffered from falls at greater than twice the rate of those taking the placebo.
Voluntary reports sent to the FDA by caregivers have indicated that Nuedexta potentially causes a number of side effects and actual harm to the patient. The reports have listed the following events:
- 51 deaths
- 113 hospitalizations
- 102 cases of sedation and sleepiness
- 101 cases of dizziness, confusion, and falls.
One report to the FDA told the story of an 86-year-old Alzheimer’s patient’s rapid decline and subsequent death after taking Nuedexta. In the words of the nurse-practitioner who filed the report, “The patient seemed to be doing fine until she was placed on Nuedexta.”
Big Bucks for Big Pharma
Before Nuedexta, compounding pharmacists often combined dextromethorphan and quinidine to create a medicine for those with PBA, at the cost of less than a dollar a pill. Nuedexta, on the other hand, goes for over $12 a pill—and it is administered twice a day. Over half of all Nuedexta pills sold since 2012 have ended up in all types of long-term care facilities; sales from 2012 to 2016 spiked almost 400 percent.
Avanir allegedly instructed its sales force to target doctors aggressively in order to sell the drug. At times, the persuasion spilled over into illegal activity, such as compensating doctors with travel, meals, and payments for promoting and prescribing the drugs. Such compensations are known as kickbacks, and they are illegal under Medicare rules. One doctor in Ohio who received payments is being investigated for allegedly fraudulently diagnosing patients with PBA and receiving kickbacks for prescribing the drug.
The Latest Clinical Trial
As of mid-July, 2017, a clinical trial for the drug is ongoing in Phoenix (“Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer’s Disease”). We hope that the conclusions drawn by this study will shed new light on Nuedexta and its possible harm to those with dementia.
Seeking Truth, Securing Justice for Seniors
When someone you love has been hurt, it can feel like nothing will ever be right or fair again. When this happens, the South Carolina nursing home injury lawyers at the Louthian Law Firm can review your legal options and work with you to determine the most appropriate next step. While a lawsuit cannot restore someone’s health, a South Carolina nursing home injury claim can help recover the large sums spent on a neglectful or abusive nursing home, as well as medical bills created by that abuse or neglect. You may also be able to hold the abusers accountable for the pain and suffering they caused.
If a senior family member has had an adverse reaction to Nuedexta or to another drug, we also have valuable information for you regarding medical malpractice. We can review your legal options to determine the most appropriate next step. You should speak with an experienced attorney like the ones at the Louthian Law Firm as soon as possible. For a free consultation, call us today at 803-454-1200.