What if you found out that your elderly loved one was given a prescription drug not because they medically needed it, but instead to control “unruly” behavior? Are nursing homes drugging our elderly in order to suppress and control residents with dementia? Several recent reports may indicate that the prescription drug Neudexta is being used for such purpose.
Neudexta, produced by Avanir Pharmaceuticals, is FDA approved to treat a condition known as pseudobulbar affect (PBA). PBA causes sudden bouts of uncontrollable laughing or crying and is most often associated with multiple sclerosis or Lou Gehrig’s disease. It is extremely rare for PBA to accompany dementia, though the FDA has approved Neudexta for use in these rare instances. PBA affects less than one percent of the population, but somehow sales of Neudexta have quadrupled in the last four years.
According to data obtained from QuintilesIMS, which tracks pharmaceutical sales, more than half of all Neudexta prescriptions have been written to residents in long-term care facilities, although the drug has had limited testing on elderly patients. Indeed, in this document filed with the FDA, the drugmaker stated, “Of the total number of patients with PBA in clinical studies of NUEDEXTA, 14 percent were 65 years old and over, while 2 percent were 75 and over. Clinical study of NUEDEXTA did not include sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients.”
The number of Neudexta pills prescribed rose to roughly 14 million in 2016, which was an increase of 400% when compared to four years prior. Through a CNN investigation, it was uncovered that an Avanir Pharmaceuticals paid speaker, who was also a psychiatrist in a Los Angeles nursing home, had prescribed Neudexta to over a quarter of his nursing home residents.
Why is a medication for a rare condition being prescribed more often? The CNN investigation found that state regulators discovered nursing home doctors are using the medication to try and suppress the confusion and unruly behavior sometimes associated with dementia. Managing a patient with dementia can be difficult and time-consuming, and doctors have been using Neudexta to subdue the patients and have more control over them. A California nursing home worker admitted to inspectors that Neudexta was prescribed for a patient that did not have PBA, but rather to control “mood disturbances” and yelling of a patient.
Many doctors who are mis-prescribing Neudexta for this purpose are facing professional complaints. One such doctor is Robert Tilley. Tilley was summoned by the Oregon Medical Board to answer questions about prescribing Neudexta to dementia patients who did not have PBA. In addition to this disciplinary action, Tilley was already banned by the state from treating inmates and had four recent malpractice suits settled. However, even after all of these professional discretions, Tilley was a paid spokesperson for Avanir Pharmaceuticals, to promote Neudexta. This leads us to our next answer as to why this drug is being prescribed so often.
In addition to controlling patients with dementia, another reason for the high rate of Neudexta prescriptions is that doctors sometimes get a financial kickback for prescribing this medication. Avanir Pharmaceuticals, and its parent company Otsuka, paid medical professionals almost $14 million between 2013 and 2016 to promote Neudexta. While this activity is not illegal, it can seem unscrupulous to some. According to CNN’s report, “Nearly half the Nuedexta claims filed with Medicare came from doctors who had received payments or meals from the drugmaker.”
Side effects of Neudexta include dizziness, weakness, easy bruising or bleeding, flu-like symptoms, headaches, hallucinations, and liver problems. One recent study found that Alzheimer’s patients who took Nuedexta experienced falls at more than twice the rate of patients who took a placebo. Numerous reports have been filed with the FDA and state regulatory agencies complaining about the dangers of Nuedexta. Side effects of prescription medication should be taken seriously and weighed against the benefits of such medication, through candid and thoughtful conversations with medical professionals. One should not be subjected to harmful side effects as a by-product of constructive chemical restraints.
While some doctors claim Nuedexta has been prescribed with good results, many experts are questioning its use and effectiveness among the nursing home population. It is good practice to look at each medication prescribed to your elderly loved one and make sure that a reputable doctor prescribed it for a legitimate medical condition. If you have concerns that Nuedexta has been erroneously prescribed to your loved one, speak with their doctor or contact the FDA to file a complaint.