Potentially severe adverse reactions including death warrant reconsideration of Nuplazid.  The drug continues to be heavily promoted to the public on television commercials and to the profession in journal advertisements.  Unfortunately Nuplazid offers few benefits compared to the major risk of complications.  Marketed as a breakthrough therapy to combat the hallucinations and delusions associated with Parkinson’s Disease, it barely surpassed the merits of an inactive placebo.  Except the placebo was neither associated with death nor did it cost anywhere near the staggering $30,000 a year commanded by Nuplazid.

 

During Nuplazid’s short time on the market, the Food and Drug Association Adverse Events Reporting System or FARES received more than 5700 reports of problems associated with the drug.  This included more than 1800 serious reactions and 712 deaths.  Although FARES cannot definitively assign cause and effect linkage, the situation appears extremely worrisome.

 

Nuplazid fits into the category of atypical antipsychotic medicines widely used to treat schizophrenia and bipolar disorder.  However the company behind Nuplazid narrowly focused on issues related to Parkinson’s Disease.  Acadia Pharmaceuticals not only sponsored and funded research on Nuplazid but also contributed to the writing of the solitary article the FDA relied upon to authorize sales in the United States.

 

Even in this brief study lasting only 6 weeks Nuplazid demonstrated almost a 300% greater incidence of serious side effects compared to an inactive placebo.  This created sufficient alarm that an FDA reviewer expressed caution regarding the merits of approving the drug.  Inexplicably the FDA acquiesced and authorized sales of Nuplazid.  Since its mid-2016 debut the drug has been associated with multiple cases of the severe movement disorder known as Tardive Dyskinesia as well as a series of other worrisome events.

 

Recently toxicity related to Nuplazid gained national media attention with CNN highlighting a variety of harms associated with the drug.  A member of the U.S. House of Representatives commented she remained unaware of any reason the drug still remained on the market.  The Commissioner of the FDA now believes a more thorough vetting of Nuplazid seems necessary and appropriate.

 

In spite of this, advertisements continue apace well financed by this inexplicably expensive $30,000 drug paid for in large measure by tax payer funded Medicare and Medicaid dollars removed from the public treasury.  And to add further insult, company sponsored trials continue with the goal of expanding Nuplazid’s authorization for treatment of an expanded portfolio of additional diseases.

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