McKnight’s had an article about FDA concerns over the use of Nuedexta as a chemical restraint. Nuedexta is the only drug approved to treat uncontrolled laughing and crying due to pseudobulbar affect. However, some nursing homes are using it for residents without pseudobulbar affect. It’s a rare condition yet the U.S. government is cautioning private insurers to look for suspicious off-label use there because officials fear the drug is being misused to control behavior.
A CNN investigation published in October found Nuedexta’s maker had been “aggressively targeting frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe.” CNN unearthed what seems to be a concentrated effort to keep the increasingly controversial drug in nursing home’s formularies. The station obtained complaints sent to the Food and Drug Administration from insurers and nursing home physicians who questioned the maker’s marketing and advertising tactics.
In a follow-up article published Monday, the news organization said the Centers for Medicare & Medicaid Services issued a March memo asking Medicare Part D providers to monitor prescriptions for appropriate use.
The CMS memo told plan sponsors that Nuedexta is only approved to treat pseudobulbar affect, and that they are legally required to ensure the drug is only covered for medically-accepted prescriptions. Neudexta’s maker, Avanir Pharmaceuticals, has said that dementia patients may suffer from PBA. No medical research supports that contention. Since the drug launched in 2011, CNN reports Avanir has generated millions of dollars in annual sales in nursing homes.