Safety of Parkinson's Drug Nuplazid (pimavanserin) Being Reviewed by FDA
The safety of the Parkinson's disease drug Nuplazid is being reviewed by the U.S. Food and Drug Administration.
The drug has been cited as a "suspect" medication in hundreds of deaths reported by health care providers, CNN reported.
Nuplazid, the only drug approved to treat hallucinations and delusions in Parkinson's disease patients, was approved by the FDA despite concerns that not enough was known about its risks.
At a congressional budget hearing last week, FDA Commissioner Scott Gottlieb said he would "take another look" at Nuplazid. The FDA this week told CNN that a review of the drug was launched several weeks ago.
The agency said the decision to review the drug was based on a number of factors, but would not specify those factors. Doctors should not stop prescribing the drug or take patients of it while the safety review is conducted, the FDA said.
Death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson's disease who had many medical conditions and often took other medications that can increase the risk of death, according to the FDA.
However, some medical experts say the high number of death reports citing Nuplazid warrant further examination to determine what role the drug may have played, and expressed concern that the drug was approved too quickly, with too little evidence that it was safe or effective, CNN reported.
Posted: April 2018
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