WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Wednesday it was reviewing Acadia Pharmaceuticals’ Parkinson’s medication, the only approved drug used to treat hallucinations and delusions associated with the disease.
CNN first reported that FDA was re-examining the safety of Acadia’s Nuplazid, which was approved by the agency even though there were concerns that not enough was known about the drug’s risks. CNN also reported earlier this month that the FDA received a spike in “adverse events reports” among those using the drug, including death, but those reports do not necessarily prove that the drug caused the event.
“The FDA is conducting an evaluation of available information about Nuplazid,” an FDA spokeswoman said. “This review has been going on for several weeks. We have nothing more to share at this time.”
Acadia’s shares fell more than 20 percent in afternoon trading.
Reporting By Yasmeen Abutaleb; editing by Diane Craft