FDA concludes examination of Parkinson's drug
Nuplazid, which hit the market in 2016, is the only medication approved to treat hallucinations and delusions associated with a debilitating condition known as Parkinson's disease psychosis. It has been cited as a "suspect" medication in hundreds of deaths voluntarily reported to the agency, as highlighted in a CNN report earlier this year.
Medical experts told CNN at the time that the high number of so-called "adverse event reports" deserved a closer look to determine whether they were related to the drug. They also recommended further testing of Nuplazid, worrying that the drug had been approved too quickly, based on too little evidence that it was safe or effective.
Nuplazid's initial review was expedited by the FDA because it had been designated a "breakthrough therapy," meaning it demonstrated "substantial improvement" in patients with serious or life-threatening diseases compared to treatments already on the market.
After CNN published its investigation on Nuplazid, reporters were contacted by family members who said they believed the drug contributed to their loved one's decline or death. Others said Nuplazid helped tame hallucinations with few apparent side effects.
The FDA has noted that the death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson's disease who suffered from numerous medical conditions and often take other medications that can increase the risk of death.
On Thursday, the FDA said it had completed a review of these deaths and other adverse events that had been reported to the agency.
"Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of Nuplazid for Parkinson's disease psychosis," it stated.
Acadia Pharmaceuticals, the company that manufactures Nuplazid, welcomed the FDA findings. "Nothing is more important to Acadia than the wellbeing of the patients who use Nuplazid," Steve Davis, the company's president and chief executive officer, said in a statement. "We are very pleased with the FDA's clear statement reaffirming Nuplazid's positive benefit-risk profile."
Dr. Paul Andreason, the physician who led the FDA's initial medical review of Nuplazid, had warned at the time of Nuplazid's approval that patients taking the drug during the company's clinical trials experienced serious outcomes, including death, at more than double the rate of those taking the placebo. But the FDA ruled that the potential benefits outweighed the risks, agreeing with an advisory committee that cited a lack of safe alternatives and the pleas from family members who claimed the drug was already helping or could help their loved ones.
In its statement this week, the FDA noted that like other antipsychotics, the drug already has the agency's most severe "black box" warning about the increased risk of death for the treatment of elderly dementia patients.
The agency also said its review had found "potentially concerning prescribing patterns," such as the use of Nuplazid with other antipsychotic drugs or with medications that can cause heart issues. It urged health care providers to familiarize themselves with the warnings and precautions associated with Nuplazid when prescribing it to patients.
The FDA said it would continue to monitor reports of adverse events and encouraged patients and doctors to report any suspected side effects to the agency.
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This story has been updated with a statement from Acadia Pharmaceuticals.
Ground beef producer issues recall due to deadly E. coli outbreak
Eighteen people have become sick with E. coli illness linked to this meat. One of them died.
The recalled meat, which may be contaminated with E. coli, is from the chuck portion of the carcass and was produced June 21. The USDA inspection mark on the package says "EST. 86R" inside. The products have been distributed nationwide.
According to the US Centers for Disease Control and Prevention, illnesses have been reported in four states: Colorado, Florida, Massachusetts and Tennessee. The sick individuals began experiencing symptoms between July 5 and 25.
Symptoms of E. coli begin between one and 10 days after consuming contaminated food or drink, but most people become sick three to four days after exposure, the CDC says.
Symptoms can include diarrhea that is sometimes bloody, vomiting and fever. Most people recover after five to seven days. Some individuals, about 5 to 10%, develop a type of kidney failure called hemolytic uremic syndrome.
A recall of ground meat products from the same Colorado-based company was announced in August for ground meat products sold at Publix locations. At the time, the company reported E. coli illnesses but no deaths.
The USDA's Food Safety and Inspection Service "is concerned that some product may be frozen and in consumers' freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase," said the recall announcement issued Wednesday.
The agency reminded consumers to use a meat thermometer to assure an internal temperature of at least 160 degrees Fahrenheit, which is necessary to kill bacteria that can cause illness.