When a person suffers a traumatic brain injury or develops certain neurological conditions, it can lead to other secondary conditions that impact behavior and mental functions. These secondary conditions only serve to exacerbate the original trauma or condition.
Pharmaceutical companies are continuously formulating new drugs aimed at treating these conditions. But do they always have a patient’s best interest at heart? Or does profit trump patient well-being?
In the case of the prescription drug Nuedexta and its manufacturer Avanir Pharmaceuticals, it may be profit that is motivating the number of prescriptions being doled out to patients. The evidence for this may not lie in the millions of dollars in sales the company is raking in each year from its first-in-its-class drug, but the number of suspicious prescriptions and illegal kickbacks uncovered by a CNN investigation in 2017.
Nuedexta is the only drug of its kind approved by the U.S. Food and Drug Administration to treat pseudobulbar affect (PBA). PBA is a rare condition that causes people to have sudden and frequent episodes of uncontrollable laughing or crying. It can occur after a traumatic brain injury or because of neurologic conditions such as multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). PBA can cause anxiety or embarrassment, especially if it happens in public.
The FDA approved Nuedexta in 2010, and since then it has brought in millions of dollars in annual sales for its manufacturer, Avanir Pharmaceuticals. Many patients with Nuedexta prescriptions include elderly dementia patients living in nursing homes. A CNN investigation into Avanir found the company was involved in potentially fraudulent practices, pushing doctors to use fake PBA diagnoses to secure Medicare funding1.
CNN found Avanir was “aggressively targeting elderly nursing home residents for whom the drug may be unnecessary or unsafe.” The investigation also found that some healthcare professionals were inappropriately prescribing Nuedexta to dementia patients using a false PBA diagnosis when in reality the drug was being prescribed to control “unruly behaviors.”
While some dementia patients may suffer from PBA, federal regulators are now concerned that Medicare is paying for Nuedexta prescriptions for unapproved and possibly fraudulent uses. Diagnosing a patient with a condition like PBA in order to secure Medicare coverage is fraud.
Now, the government is looking into whether or not Avanir engaged in fraudulent activities, and is warning insurance companies to be on the lookout for suspicious Nuedexta prescriptions2.
In addition to potential fraud that could be costing the federal government millions of dollars in the form of Medicare Part D prescription funding, Nuedexta carries the risk of potentially dangerous side effects. Meaning possibly thousands of people could be falsely diagnosed with PBA and prescribed a drug that may be not only unnecessary but also unsafe.
Nuedexta has never been approved to treat agitation or other behaviors associated with Alzheimer’s disease and dementia. In fact, the Nuedexta label now includes language explicitly stating the drug is not proven safe or effective to treat agitation in these patients.
“NUEDEXTA has not been shown to be safe or effective in other types of emotional lability that can commonly occur, for example, in Alzheimer’s disease and other dementias.”
In spite of this, Avanir Pharmaceuticals actively pushed for sales of Nuedexta to one of the country’s most vulnerable populations: the elderly. Lawsuits against Avanir are now being filed by patients and their family members to hold Avanir accountable for its potentially fraudulent practices and the harm caused by unnecessary or unsafe prescriptions of Nuedexta.
Nuedexta is a combination drug made up of dextromethorphan and quinidine, which act on different receptors in the brain to treat PBA. Nuedexta is approved to treat PBA in patients with ALS and MS; however, it is not shown to be safe or effective in people with Alzheimer’s disease or dementia.
Nuedexta hit the market in 2011 after granted approval from the FDA in 2010. At the time, Nuedexta was the first and only drug approved to treat PBA. Keith Katkin, then-president and chief executive officer of Avanir, said the FDA’s approval marked “an important milestone for people living with PBA, an under-recognized and debilitating neurologic condition.”
Nearly eight years after the drug’s approval, the government is keeping watch on Nuedexta prescriptions to ensure it is appropriately given to patients. Nuedexta’s dangerous side effects can potentially occur when given to patients who do not suffer from PBA. These sever side effects are why patients affected by Nuedexta are beginning to file lawsuits against its manufacturer. The manufacturer of Nuedexta, Avanir, is accused of paying kickbacks to doctors who prescribe Nuedexta to patients for off-label uses. While prescribing a drug for off-label uses is not illegal, paying kickbacks to doctors is. Aggressively marketing a drug for purposes that are not approved by the FDA is also unlawful.
Nuedexta is not an antipsychotic. Categorized as a “Central Nervous System, Other” by the agency that classifies prescription drugs for Medicare reimbursement purposes, Nuedexta works by acting on different receptors in the brain, though the exact mechanism of action is unclear.
Antipsychotics work by altering the effects of certain chemicals in the brain and are primarily used to manage psychosis, especially in schizophrenia and bipolar disorder. Nuedexta, on the other hand, is approved only to treat PBA.
Nuedexta, like all medications, comes with the risk of certain side effects. The most common side effects of Nuedexta (but are not limited to):
Other common side effects include (but are not limited to):
Other adverse effects may also occur when taking Nuedexta. These include worsening of the condition myasthenia gravis, which can occur because of the effects of quinidine, one of the components of Nuedexta. Myasthenia gravis is a condition marked by rapid muscle fatigue, causing droopy eyelids and a droopy mouth.
Hypersensitivities to quinidine in Nuedexta can also occur, which could be fatal if left untreated. Look for signs of an allergic reaction, which can include:
These symptoms could mean the body is having a negative reaction to the drug, as allergic reactions are possible.
Nuedexta may also interfere with certain other medications and contradict with quinidine (since Nuedexta already contains quinidine) and the class of antidepressants known as MAOIs.
For a complete list of side effects and possible drug interactions, check the Nuedexta label or call your doctor.
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