Neudexta: A Cautionary Tale

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Last week CNN published an investigative report that concluded that Avanir Pharmaceuticals was paying physicians to prescribe its drug, Neudexta, to Alzheimer’s patients under the pretext that these patients have a rare disease. CNN’s research revealed a 400% increase in the sale of Neudexta in the past four years, and more than half of the sales were traced to physicians and pharmaceutical representatives who had received meals or payments from Avanir.

 

What is Neudexta?

The FDA has approved Neudexta solely for the treatment of PBA, pseudobulbar affect, which causes uncontrollable laughing or crying. It is a very rare condition affecting an estimated 1% of the population. It is associated most commonly with ALS (Lou Gerhig’s Disease) and multiple sclerosis. Common side effects from this drug include dizziness, gastrointestinal problems and drowsiness.

 

Does Neudexta’s Use Include Treatment of Alzheimer’s Symptoms?

The FDA has only approved Neudexta for those diagnosed with PBA. Avanir promotes its drug by identifying Alzheimer’s patients with documented behavioral issues and finding physicians to diagnose the behaviors as PBA. There are no studies that indicate that PBA is associated with Alzheimer’s, and there have been no independent clinical trials to determine either the efficacy or safety of this drug for those with Alzheimer’s.

 

The Link to Anti-Psychotic Drugs

Neudexta seems to have a sedating effect on patients, which some nursing homes would find attractive. Facilities used to administer anti-psychotic drugs to control patients. However, patient advocates successfully challenged the indiscriminate use of these drugs, and now Medicare tracks how many residents receive these medications in each nursing home. High utilization will lower a nursing home’s rating on Nursing Home Compare, the CMS consumer site for nursing home evaluations.

Neudexta is not classified as an anti-psychotic drug. Nursing homes can administer the drug without being penalized in its CMS ratings. ? CNN found that Avanir targeted nursing homes that had a profile of high anti-psychotic use. It appears that CNN has uncovered patterns of behavior that deserve a much closer look.

 

Take Aways for Families

Medications are powerful and should be recognized for the potential they have to both cure and cause dangerous side effects. Know the medications your family member is taking, and why it has been prescribed.

There are no medications that prevent or cure Alzheimer’s disease.

There are only a few drugs that have been approved for Alzheimer’s and they slow the progression of the disease for short periods. They too have side effects.  Ask your physician how these approved medications should be used.

Many experts in the field of Alzheimer’s consider agitated or aggressive behavior to be the patient’s attempt to communicate an unmet need. Work with the nursing home staff to help them understand what your family member may want or need. It is likely to be more effective than any drug.

 

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