“Breakthrough Therapy” Parkinson’s Drug Raising Safety Concerns

Approximately one million Americans are living with Parkinson’s disease, a neurodegenerative disorder that can cause tremors, balance issues, hallucinations and delusions, among other symptoms, making it the 14th cause of death in the United States.

But in April 2016, there was hope for relief from at least some of the symptoms, a new drug approved to help with the hallucinations and delusions associated with Parkinson’s. The drug, Nuplazid, had undergone a six-week trial with two hundred patients before it was approved by the F.D.A. by a vote of 12-2 in favor. Those who voted against the approval expressed reservations with the short trial period and uncertainty of the drugs effectiveness.

Since then, more than 1,800 ‘adverse event’ reports have been filed with the F.D.A., and at least 500 people have died while taking the “breakthrough therapy” drug (which is manufactured by Acadia Pharmaceuticals.)

Dr. Diana Zuckerman, president of the National Center for Health Research, weighs the cost-benefit analysis to shed light on the efficacy of this new drug.

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