FDA is re-examining the safety of a breakthrough Parkinson’s disease drug after reports of hundreds of deaths.
Pimavanserin (Nuplazid, Acadia Pharmaceuticals), the only drug approved to treat hallucinations and delusions associated with Parkinson's disease psychosis, is suspected in hundreds of deaths voluntarily reported by caregivers, doctors and other medical professionals since it hit the market, CNN reported.
"What does it take for a drug like this to be taken off the market?" asked US Rep. Rosa DeLauro, former chair of the congressional subcommittee responsible for funding and overseeing FDA, at a recent Congressional hearing, CNN reported. "How many more adverse events do we have to have reported? How many people, quite frankly, have to die?” DeLauro asked FDA Commissioner Scott Gottlieb, MD, at the hearing.
However, FDA had already begun conducting a new review of the drug because of "potential signals of serious risk/new safety information" in part by using adverse event data, CNN reported. However, the agency is not suggesting physicians stop prescribing the drug while a safety evaluation is taking place.
Death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson's disease who suffered from numerous medical conditions, according to FDA.
However, the high number of death reports deserved a closer look to determine whether they were related to the drug, sooner, medical experts and physicians told CNN. “They also recommended further testing of Nuplazid, worrying that the drug had been approved too quickly, based on too little evidence that it was safe or effective,” CNN said.
Nuplazid's review was expedited by FDA because it had been designated a breakthrough therapy.