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Off-Label Use of Nuedexta Can Increase Fall Risk for Dementia and Alzheimer’s Patients

If you have a parent or loved one in a nursing home, it’s always smart to stay on top of the medications being prescribed and inquire about their safety and intended benefit for your loved one. For those afflicted with dementia or Alzheimer’s in a nursing home, it may be especially wise to be vigilant about the pills being given to them. For years, we’ve heard reports of nursing home staff using unnecessary tranquilizing drugs to make shifts more tolerable for staff. Now, reports have surfaced that Nuedexta, a drug intended to control a rare disorder called pseudobulbar affect (PBA), is being frequently misused to ‘treat’ patients with dementia and Alzheimer’s. PBA is a condition that causes the sufferer to laugh or cry uncontrollably and is most often seen in those diagnosed with Lou Gehrig’s Disease (ALS) and multiple sclerosis (MS). According to Nuedexta’s maker, Avanir Pharmaceuticals, PBA only affects 1% of the population, a number which has remained steady since the drug first went on the market, despite sales of the pills increasing 400% since 2012. Not so ironically, over half of the drug’s sales are to nursing homes and the payments and kickbacks to physicians treating these patients are soaring.

Off-Label Use Associated with Higher Fall Risk
The problem with using Nuedexta on a patient who is not suffering from PBA is that the drug can have unknown side effects. During the FDA approval process for the drug, several doctors said that there was weak evidence to show that the drug had any benefit to patients suffering from Alzheimer’s or dementia and strongly urged the association to label the drug only for use in MS or ALS patients with PBA. The FDA declined, only to be flooded with over 1,000 adverse incident reports that cite Nuedexta as a suspicious drug related to various side effects, comas, and deaths in patients with dementia and Alzheimer’s. Geriatric experts have told CNN that the drug’s own labeling says that the drug was not rigorously tested for use in elderly patients.

An Avanir-funded study found that Alzheimer’s patients given Nuedexta were twice as likely to fall as compared to patients given a placebo. The company was questioned by Mass Tort Nexus about the safety of the drug for those without a PBA diagnosis and stated that PBA was misunderstood and that it actually affects 40% of dementia patients, something that medical experts in the field of geriatrics say is absolutely untrue. A diagnosis of PBA should be made by a qualified physician and based on symptoms identified through various clinical questions. It it not diagnosable by blood test or other brain or body imaging, although a physician may order an EEG to rule out a form of epilepsy that has symptoms similar to PBA.

Find out If A Physician Has Received Incentives from Drugmakers
Curious if your parent or loved one’s physician has received money, meals, or other incentives from a pharmaceutical company? The Centers for Medicare and Medicaid Services operates a directory that catalogs the dollar amount of all payments and incentives received. Please remember that most prescription drugs are life saving, incredible forms of treatment. Just because a physician has a relationship with a drug company is not inherently a bad thing. The problem arises when greed overtakes ethical behavior and physicians prescribe medications off-label without regard to the individual and the potential negative outcome of using drugs for whom they are not intended. Combine poor decision making by physicians with a reportedly aggressive Avanir sales force and you have the perfect scenario for a suddenly popular drug at the expense of patient safety.

To find out if your doctor or a loved one’s doctor has a relationship with a drugmaker, click here. If the number seems abnormally high compared to the national mean or the mean for their specialty, it might be time to ask questions if a drug made by that pharmaceutical company is being prescribed to you or a loved one and you suspect it may be unnecessary or harmful.