The Food and Drug Administration (FDA) is re-examining a new Parkinson’s drug after reports of serious side effects and numerous deaths. Nuplazid, a drug approved in 2016, has been cited as a “suspect” medication in hundreds of deaths voluntarily reported by caregivers, doctors and other medical professionals. The agency said the review had started several weeks ago.
The agency said the FDA’s new evaluation of Nuplazid was based on a number of factors but did not say what those factors were. The drug was approved to treat delusions and hallucinations associated with Parkinson’s disease psychosis. Nuplazid is the only drug on the market that’s approved for this type of treatment.
Nuplazid was approved as a “breakthrough therapy,” a designation created by Congress in 2012 to speed up the FDA’s approval process. About 200 drugs have been granted this designation since its creation. Physicians, researchers and other medical experts are now recommending further testing of Nuplazid amid worries that the drug had been approved too quickly. During the first 10 months Nuplazid was on the market, 244 deaths were reported to the FDA in which Nuplazid was a “suspect” medication.
In 2017, there were 600 reported deaths associated with Nuplazid. The death reports citing the have mostly involved elderly patients with advanced-stage Parkinson’s disease who suffered from numerous medical conditions. It is possible that these patients were also taking other medications that could increase the risk of death. An adverse event report does not mean that a suspected medication has been ruled the cause of the harm suffered by the victim.
During a House hearing last week, Rep. Rosa DeLauro (D-Conn.) asked FDA Commissioner Scott Gottlieb what it would take to get the drug off of the market. DeLauro is a member and former chair of the congressional subcommittee responsible for funding and overseeing the FDA.
The exchange grew tense as DeLauro said, “How many more adverse events do we have to have reported, and how many people quite frankly have to die? Why does the industry always take precedence over public health and safety?” Gottlieb declined to comment specifically about Nuplazid’s risks, but said he would “go back and take another look” at the drug.