The Federal Drug Administration issued a cautionary note on Thursday concerning a new daily pill from Pfizer to help boost heart-rate control for people with age-related and other cardiovascular risk factors. The pill, called Nuplazid, is meant to help patients stay at a healthy heart rate throughout the day, the statement said.
The agency posted a list of potential side effects, including depression, suicidal ideation, suicidal attempts, seizures, and dizziness. That is similar to the list for the company’s Xtandi, another product that is used to treat prostate cancer.
The FDA was charged in May with making the decision to approve Nuplazid, which has been sold in Europe since 2016. It is the first drug to be approved in the United States to treat Parkinson’s disease psychosis, a cognitive disorder that leads patients to lose control of their movements and voices.
The FDA announced on Monday that it would grant another three-month review to the marketing application submitted by the company.
On Thursday, Pfizer said that Nuplazid had gained “favorable” reviews from medical societies and it was generally received by the medical community as “highly effective.”
“We are looking forward to a positive outcome in June,” said Dr. J. Leonard Herl, a cardiologist at the Mayo Clinic in Rochester, Minn., in the statement. “We are encouraged by the potential benefits of Nuplazid, especially for patients with Parkinson’s disease psychosis.”