Compensation Possible for Elderly Patients Harmed by Nuedexta

Before a medication is prescribed to a patient, two important questions should be asked:

• Has it been carefully investigated and found to be safe and effective for the purpose and the patient group for which it is being used?
• Is it medically appropriate and necessary?

These questions are part of a controversy currently making news headlines about the drug Nuedexta.

Nuedexta’s Use

Nuedexta is a prescription drug used to treat a fairly rare disorder known as pseudobulbar affect (PBA).  This condition causes individuals to have uncontrollable and inappropriate fits of laughing and/or crying.  Patients with this malady usually have an underlying neurological disease such as multiple sclerosis or amyotrophic lateral sclerosis (ALS/Lou Gehrig’s disease).  It is estimated that approximately 2 million people in the United States suffer from PBA.

In recent years, Nuedexta has been marketed for other medical purposes in addition to PBA.  An investigative report by CNN found that the drug is now most often used in nursing homes as a sedating agent for elderly patients.  The majority of these patients do not have a diagnosis that would necessitate use of Nuedexta.

Since 2012, more than half of Nuedexta prescriptions have been dispensed to elderly care facilities.  This use has raised many questions about the safety of the drug for the purpose of sedation, and numerous claims  have been made concerning serious side effects, including death.

Side Effects

As with most prescription medications, Nuedexta is accompanied by a long list of both common and serious side effects.  Some of these side effects can be especially hazardous for the elderly population.  Common side effects of Nuedexta are as follows:

• Diarrhea
• Dizziness
• Cough
• Vomiting
• Weakness
• Swelling of Feet and Ankles
• Urinary Tract Infection
• Flu-like Symptoms
• Muscle Spasms

Serious side effects of Nuedexta are as follows:

• Allergic Reactions
• Severe Dizziness or Fainting
• Fast or Pounding Heart Beat
• Easy Bruising or Bleeding
• Pain or Burning When Urinating – Dark Urine
• Signs of Infection (fever, chills, sore throat)
• Yellowing Eyes or Skin
• Clay-Colored Stools
• Joint or Muscle Pain
• Chest Pain
• Agitation or Hallucinations

Aggressive Marketing for Use with Elderly Patients

Nuedexta’s manufacturer and marketer, Avanir Pharmaceuticals (a subsidiary of Otsuka Pharmaceutical Co.), admits in its prescribing information that the drug has not been extensively studied in elderly patients.  Despite this, the company is accused of heavily marketing the drug for use with seniors who are agitated due to cognitive disorders like dementia or Alzheimer’s disease.

A recent investigation into these aggressive sales tactics claims that Avanir hired physicians who had previously been disciplined by state medical boards to market Nuedexta.  The company is said to have paid out millions of dollars in its efforts to sell the drug, and these efforts paid off with positive results – a 400% increase in sales in 4 years resulting in $300 million of sales in 2016. However, Avanir Pharmaceuticals is currently under investigation for possible unethical and illegal practices.  In the midst of this probe, the firm has planned to lay off approximately 11% of its workforce by the end of January 2018.

Adverse Events

From 2011 to 2017, more than 1,000 adverse events have been reported to the U.S. Food & Drug Administration (FDA).  Of these 1,000 reports, 298 were considered serious, including 73 death cases.

In patients age 65 and above, 170 total cases were reported, with 62 of those considered serious events including 28 death cases.  The top five adverse drug reactions in this age group were:

• General disorders and administration site conditions
• Nervous system disorders
• Injury, poisoning and procedural complications
• Psychiatric disorders
• Gastrointestinal disorders

The risk of falls is another serious consideration when medicating elderly patients.  CNN reports that in a study conducted by Avanir, patients suffering from Alzheimer’s disease who took Nuedexta experienced falls at twice the rate as those who were given a placebo.

Your Legal Options

If you or a member of your family have suffered a severe reaction to Nuedexta, or if a member of your family has died as a result of complications from the drug, you may be able to take legal action.