Report: Regulators Issue Warning Related to Nuedexta Investigation

Attorneys are looking into reports related to the aggressive promotion and marketing of prescription medication Nuedexta. According to an investigation by CNN, pharmaceutical sales representatives affiliated with the drug’s manufacturer, as well as some doctors, reportedly targeted nursing home residents in order to unnecessarily and inappropriately prescribe the medication. In many cases, the drug was prescribed to frail and elderly nursing home residents with dementia or as an excuse to curb unmanageable behavior. Affected patients and their families may be able to pursue a claim and recover compensation with the help of a dangerous drug attorney.

If you or a loved one have been adversely affected by a potentially dangerous drug, contact Attorney Group to learn about your options. We offer free, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.

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What is Nuedexta?

Nuedexta is a prescription medication used to treat pseudobulbar affect (PBA), a condition characterized by an involuntary and uncontrollable reaction of laughter or crying in response to a situation.

PBA may occur in addition to conditions affecting the brain, such as stroke, amyotrophic lateral sclerosis (ALS), and multiple sclerosis. According to the drug’s prescribing information, PBA episodes are usually unrelated to the underlying emotional state of the patient and are “distinct from other types of emotional lability that may occur in patients with neurological disease or injury.”

Nuedexta is a combination of dextromethorphan hydrobromide (commonly used as a cough suppressant) and quinidine sulfate (an ingredient used to increase the effectiveness of dextromethorphan). Nuedexta is manufactured by Avanir Pharmaceuticals, a California-based division of Japanese pharmaceutical company Otsuka Pharmaceutical.

CNN Nuedexta Investigation

Although Nuedexta is approved only for the treatment of PBA, reports indicate that Avanir Pharmaceuticals may have been attempting to cleverly promote materials, leading some doctors to prescribe the medication for other behavioral conditions under the guise of a PBA diagnosis. According to a CNN investigation into Avanir Pharmaceuticals, the drug maker had been “aggressively targeting frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe.”

In 2012, BlueCross BlueShield of Arizona reportedly complained to the U.S. Food and Drug Administration (FDA) about the pharmaceutical company’s marketing and advertising in nursing homes. In their letter to the FDA, the insurance company stated that they “believe that the manufacturer appears to be marketing Nuedexta far beyond the scope of the clinical evidence.”

The investigation also revealed additional complaints filed to the FDA reportedly expressed concern regarding the possible “off label promotion of Nuedexta for diagnosis other than PBA,” specifically targeting nursing home residents with dementia with behavioral issues. While prescribing a medication for unapproved or off-label uses is not illegal, promoting a drug for off-label purposes is.

In some nursing homes, sales representatives were reportedly using promotional materials to draw attention to symptoms associated with PBA in hopes that health care professionals would locate residents who might have been experiencing or demonstrating such symptoms.

Regulators Issue Memo Asking Insurance Providers to Monitor Nuedexta Prescriptions

Avanir Pharmaceuticals claimed that many patients with dementia suffer from PBA, however; diagnosing a patient with a condition in order to secure Medicare coverage may be considered fraud, and according to the CNN report, “regulators are concerned that Medicare may be paying for the drug for unapproved and potentially fraudulent uses.”

As a result, the Centers for Medicare & Medicaid Services (CMS) issued a memo in March 2018 requesting that Medicare insurance providers monitor Nuedexta drug prescriptions, noting that insurers are required to make sure that the drug is only being prescribed for appropriate uses and treatments.

Nuedexta Side Effects

Common side effects of Nuedexta may include:

  • Diarrhea
  • Gas
  • Stomach pain
  • Muscle spasm
  • Dizziness
  • Weakness
  • Cough
  • Swelling of the hands or feet and ankles
  • Drowsiness
  • Vomiting
  • Urinary tract infection
  • Flu-like symptoms
  • Abnormal liver tests

Nuedexta may also cause other serious side effects such as easy bruising or bleeding, dark urine, signs of infection, yellowing eyes or skin, or lupus-like symptoms.

How a Nuedexta Lawsuit Attorney Can Help

Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

People injured by Nuedexta or other similar drugs may be eligible to recover money for:

  • Medical Expenses
  • Lost Wages
  • Pain and Suffering

The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.