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Coal ash likely entering North Carolina river, environmentalists say

Coal ash likely entering North Carolina river, environmentalists say

(CNN) - Coal ash is likely entering the Cape Fear River in Wilmington, North Carolina, environmentalists said Friday. Rising water in the area, due to heavy rain and storm surge from Hurricane Floren ... Continue Reading
Rate of Americans living with Alzheimer's expected to double by 2060

Rate of Americans living with Alzheimer's expected to double by 2060

(CNN) - As the aging population of the United States grows, a new study from the US Centers for Disease Control and Prevention says that from 2014 to 2060, there will be a 178% increase in the number ... Continue Reading
These tweets show why people don't report sexual assaults

These tweets show why people don't report sexual assaults

(CNN) - There's no standard way survivors talk about sexual assault. It isn't always a police phone call and a rape kit; sometimes it's years of silence. Sometimes it trickles out, little by little, ... Continue Reading
1 in 20 deaths globally are a result of alcohol use

1 in 20 deaths globally are a result of alcohol use

(CNN) - Over three million people died from alcohol consumption in 2016, equating to 1 in 20 deaths globally, according to a new report by the World Health Organization.More than 75% of these deat ... Continue Reading
Deaths on college and high school football fields are a rare -- but reliable -- tragedy

Deaths on college and high school football fields are a rare -- but reliable -- tragedy

(CNN) - This fall, more than a million kids, teens and young men will line up on the hash marks for another season of football. Millions more will watch, either as rabid fans or, increasingly, as con ... Continue Reading
World's oldest known animal identified after decades-long mystery

World's oldest known animal identified after decades-long mystery

LONDON (CNN) - The oldest known animal in the geological record has been identified, in a discovery that scientists are calling "the Holy Grail of palaeontology."Fat molecules discovered on the fos ... Continue Reading
Memories that last: What sexual assault survivors remember and why

Memories that last: What sexual assault survivors remember and why

(CNN) - Being pushed into a room, thrown onto a bed and groped: Those are the kinds of details that get embedded in a sexual assault survivor's memory. Peripheral information, like what day it was ... Continue Reading
Keeping your brain fit, by a USA Memory Champion

Keeping your brain fit, by a USA Memory Champion

(CNN) - How exactly does one keep their brain and memory strong and healthy? This was one of the driving questions I had when I began the quest to improve my memory and become a four-time USA Memory ... Continue Reading
Ongoing outbreak of rare eye infection found among contact lens wearers

Ongoing outbreak of rare eye infection found among contact lens wearers

(CNN) - An ongoing outbreak of a rare eye infection has been discovered in contact lens wearers in the UK, a new study reveals.Researchers at University College London found that rates of Acantham ... Continue Reading
A judge sided with transgender workers in a Wisconsin health insurance fight

A judge sided with transgender workers in a Wisconsin health insurance fight

(CNN) - A Wisconsin federal judge ruled in favor of two transgender women who challenged the state's insurance ban on coverage for gender-affirming care.US District Judge William Conley said in hi ... Continue Reading
FDA concludes examination of Parkinson's drug

FDA concludes examination of Parkinson's drug

(CNN) - The Food and Drug Administration announced Thursday it had not identified any "new or unexpected safety findings" related to a drug used to treat psychosis in Parkinson's patients, though it did find potentially troubling prescribing practices.

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.

Do you have information to share about Nuplazid or other drugs targeting the elderly? Email us: watchdog@cnn.com.

This story has been updated with a statement from Acadia Pharmaceuticals.

This is why people hesitate to report sexual misconduct

This is why people hesitate to report sexual misconduct

(CNN) - The news has been filled with stories of prominent men accused of sexual misconduct -- many of the alleged misdeeds going back decades. The circumstances are different in each case, but we ... Continue Reading
Why female shooters are rare

Why female shooters are rare

(CNN) - Data shows that women are rarely behind active shootings, making Thursday's massacre at a drugstore distribution center unusual. Authorities say a 26-year-old woman shot three people and w ... Continue Reading
 Globally, losing the fight against cancer and other chronic diseases

Globally, losing the fight against cancer and other chronic diseases

(CNN) - More than half of all UN countries will fail to honor their commitment to reduce premature deaths from cancer, cardiovascular disease, chronic respiratory disease and diabetes by 2030, a new ... Continue Reading
Ground beef producer issues recall due to deadly E. coli outbreak

Ground beef producer issues recall due to deadly E. coli outbreak

(CNN) - Cargill Meat Solutions issued a recall of 132,606 pounds of ground meat due to a deadly E. coli outbreak, the US Department of Agriculture said Wednesday.

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.

Celebrated food researcher to step down after research is questioned

Celebrated food researcher to step down after research is questioned

(CNN) - Cornell University professor Brian Wansink may have helped shape our country's relationship with food, but concerns about his research came to a head on Wednesday when leading medical journal ... Continue Reading
Puppies to blame for drug-resistant infection in 118 people

Puppies to blame for drug-resistant infection in 118 people

(CNN) - From January 2017 through February 2018, puppies sold at six pet store companies led to infections in 118 people in 18 states, the US Centers for Disease Control and Prevention reported Thurs ... Continue Reading
Just one in 10 English people will be smokers by 2023, study says

Just one in 10 English people will be smokers by 2023, study says

LONDON (CNN) - Just one in 10 English people will smoke cigarettes in five years and Britain could be a smoke-free society by 2030, according to Public Health England (PHE).The forecasts were made ... Continue Reading
DNA tests on elephant tusks expose 'three major export cartels operating in Africa'

DNA tests on elephant tusks expose 'three major export cartels operating in Africa'

(CNN) - A DNA sampling technique on elephant tusks has helped expose three of Africa's ivory trafficking rings, a new study says. Scientists matched information from DNA samples of elephant tusks ... Continue Reading
Parents, stop feeling so guilty about TV time

Parents, stop feeling so guilty about TV time

(CNN) - I've never met a parent at ease with the fact that their children watch television. This includes many, many lovely, curious and conscientious parents who allow their equally lovely, curious ... Continue Reading

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