Journalists have discovered that a drug developed to treat symptoms most commonly associated with multiple sclerosis and amyotrophic lateral sclerosis is being used as a dementia treatment by nursing homes in New Mexico and around the country. The U.S. Food and Drug Administration approved Nuedexta in 2010 to treat pseudobulbar affect, but the drug has not been approved to treat dementia-related agitation. PBA is characterized by uncontrolled laughter or crying, and it is very uncommon in dementia cases.
Reporters from CNN claim to have uncovered documents that reveal Nuedexta was marketed aggressively to doctors and nursing homes for the off-label treatment of dementia-related agitation. These efforts appear to have been successful because sales of the drug reached $300 million in 2016. According to CNN, about half of the Nuedexta pills prescribed in the United States in 2016 were given to nursing home residents or long-term care facility patients.
Nursing homes may be administering Nuedexta to residents suffering from dementia to avoid using harsher antipsychotic drugs. Antipsychotics can trigger serious adverse reactions, and their misuse has led to claims of abuse and nursing home negligence lawsuits. The FDA has not approved any drug to treat dementia-related agitation, which is why all treatment for the condition is off-label. The pharmaceutical company that makes Nuedexta has studied the drug as a possible treatment for agitation associated with dementia, but that research has been discontinued.
Treatment options are needed
Doctors are prescribing Nuedexta for dementia-related agitation because there are no approved treatments. Nuedexta has not proven to be an effective treatment for agitation, but the combination of quinidine and a common cough suppressant has been linked with increased fall risks. It is worrying that this drug is being used in places where falls are sometimes deadly.