The Food and Drug Administration (FDA) is re-examining the safety of a new drug after reports that it has potentially caused serious side effects and numerous deaths.
The agency confirmed to The Hill it is “conducting an evaluation of available information” about Nuplazid, a drug approved in 2016 to treat delusions and hallucinations associated with Parkinson’s disease psychosis.
CNN first reported that the agency was reviewing the drug that has been cited as a "suspect" medication in hundreds of deaths.
During a House hearing about FDA’s budget last week, Rep. Rosa DeLauroRosa DeLauroProposals to reform supports for parents face chopping block On The Money — Democrats eye tough choices as deadline looms Under pressure, Democrats cut back spending MORE (D-Conn.) pressed FDA Commissioner Scott Gottlieb to answer why the drug was still on the market, even though there were 600 reported deaths associated with the drug in 2017.
“I don’t know why it should stay on the market, especially when the FDA has not determined it to be safe. You tell me, what does it take for a drug like this to be taken off the market?” DeLauro asked.
“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?” DeLauro added.
Gottlieb said he would “go back and take another look” at Nuplazid but would not comment specifically about its risks.
Nuplazid is the only drug on the market that’s approved to treat psychosis associated with Parkinson’s.
It was approved on an expedited basis as a “breakthrough therapy,” which means it is intended to treat a serious or life-threatening disease or condition better than any other drug or treatment already on the market.
Congress created this designation in 2012 in an effort to speed up the FDA's approval process. About 200 drugs have been granted this designation since its creation.
The FDA told The Hill in an email that generally, the potential signal of a serious risk/new safety information does not mean that the agency has determined that the drug has a new risk. It would not comment specifically about Nuplazid.
The FDA tracks “adverse events” of drugs reported by manufacturers, consumers and health care professionals. The fact that an adverse event was reported doesn’t necessarily mean that the drug was the cause of it, but the FDA can use the reports to monitor potential issues and take appropriate action.