[ad_1]
Medical experts told CNN at the time that the high number of "adverse event reports" merited further investigation to determine if they were drug-related. They also recommended additional tests for Nuplazid, fearing that the drug was approved too quickly, based on too little evidence that it was safe or effective.
The initial review of Nuplazid was accelerated by the FDA as it had been designated as "revolutionary therapy," which meant a "substantial improvement" in patients with serious or life-threatening conditions compared to treatments already on the market .
After CNN released its Nuplazid investigation, family members contacted journalists who said they thought the drug had contributed to the decline or death of their loved one. Others said that Nuplazid had helped control hallucinations with little apparent side effects.
The FDA noted that death reports citing Nuplazid typically involved elderly patients with advanced Parkinson's who were suffering from many medical conditions and often took other drugs that could increase the risk of developing Parkinson's. death.
On Thursday, the FDA said it has completed the review of these deaths and other adverse events reported to the agency.
Acadia Pharmaceuticals, which manufactures Nuplazid, did not immediately respond to a request for comment.
Dr. Paul Andreason, the physician who led Nuplazid's initial medical review by the FDA, had warned at the time of Nuplazid's approval that patients taking the drug during the company's clinical trials would take the placebo. But the FDA felt the potential benefits outweighed the risks, agreeing with an advisory committee that cited the lack of safe alternatives and calls from family members who claimed the drug was helping or could help their loved ones.
In its statement this week, the FDA noted that, like other antipsychotics, the drug already contained the agency's most severe "black box" regarding increased risk of death for the treatment of elderly patients with dementia .
The agency also said that its review had found "potentially concerning modes of prescription", such as the use of Nuplazid with other antipsychotic drugs or with drugs that could cause heart problems. He urged healthcare providers to familiarize themselves with the warnings and precautions associated with Nuplazid when prescribing it to patients.
Do you have any information to share about Nuplazid or other drugs targeting the elderly? Send us an email: [email protected].
Source link
