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The Food and Drug Administration says it is re-examining the safety of a medication that was approved despite concerns that not enough was known about the drug's risks.In response to questioning at a budget hearing last week, FDA Commissioner Scott Gottlieb told members of Congress that he would "take another look" at Nuplazid, which is the only drug approved to treat hallucinations and delusions associated with Parkinson's disease psychosis.The medication has been cited as a so-called "suspect" medication in hundreds of deaths voluntarily reported by caregivers, doctors and other medical professionals since it hit the market, as highlighted in a recent CNN report.The FDA told CNN this week that the agency had already begun conducting a new evaluation of the medication when Gottlieb was questioned about it at the hearing. The agency said the review had started several weeks ago."What does it take for a drug like this to be taken off the market?" asked US Rep. Rosa DeLauro, a member and former chair of the congressional subcommittee responsible for funding and overseeing the FDA.DeLauro pressed Gottlieb for answers on his agency's response to the safety concerns surrounding Nuplazid."How many more adverse events do we have to have reported? How many people, quite frankly, have to die? Why does the industry always take precedence over public health and safety?"Tracked by the FDA, the adverse event reports cited by DeLauro do not mean that a suspected medication has been ruled the cause of harm and are typically not the result of official investigations. But the FDA uses the information to monitor potential issues with a drug and can take action as needed: updating a medication's label, for instance, or restricting its use. In rare cases, the agency can even pull a drug off the market.When asked by CNN about what prompted the FDA's new evaluation of Nuplazid, the agency said the decision was based on a number of factors but wouldn't say what those factors were. Instead, it would only comment generally, saying that it identifies "potential signals of serious risk/new safety information" in part by using adverse event data and that the agency is not suggesting physicians stop prescribing the drug or take patients off of it while a safety evaluation is taking place.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.But physicians, researchers and other medical experts told CNN that the high number of 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 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.Dr. Paul Andreason, the physician who led the FDA's medical review of Nuplazid, warned 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.At that advisory committee meeting two years ago, one woman said that her grandmother had been part of the clinical trials for the drug and that Nuplazid had been life-changing."We didn't know what to expect or even if she was on the drug" or a placebo, said Zoey Wade. "We soon realized that she must be taking the drug, because she really returned to herself. Her hallucinations reduced, and she better understood what was real and what was imaginary."Shortly after Nuplazid's release, however, patients' family members, doctors and other health care professionals started reporting "adverse events" possibly linked to the medication -- including deaths, life-threatening incidents, falls, insomnia, nausea and fatigue.During the first 10 months Nuplazid was on the market, 244 deaths were reported to the FDA in which Nuplazid was a "suspect" medication, according to an analysis conducted by the Institute for Safe Medication Practices. FDA data now show that the number of reported deaths has risen to more than 700. In more than 1,000 reports, patients continued to experience hallucinations while on Nuplazid.After CNN published its investigation on Nuplazid, reporters were contacted by family members who said the drug helped tame hallucinations with few apparent side effects and others who said they believe Nuplazid contributed to their family member's decline or death. Some said they had not yet reported these experiences to the drugmaker or the FDA.While the FDA has long been criticized for being too slow to approve drugs, DeLauro seized on its push to streamline the process, lambasting the agency for putting industry interests and efficiency above public health and safety.DeLauro described the number of adverse events and deaths as "staggering" and "unprecedented." She also expressed concern that the drugmaker, Acadia Pharmaceuticals, is attempting to get the drug approved for a larger population: patients who suffer from dementia-related psychosis."I don't know why it should stay on the market, especially when the FDA has not determined it to be safe and while the number of adverse events continues to soar," she told Gottlieb.In response to the congresswoman's remarks, Acadia told CNN that adverse event data alone are "not a comprehensive and accurate indicator of the safety profile of any drug." In response to CNN's earlier report on the drug, Acadia said there are a number of reasons for the higher volume of death reports, including the fact that the company distributes Nuplazid through a network of specialty pharmacies that puts the company in more frequent contact with both patients and caregivers -- meaning Acadia is more likely to receive reports of death, which it is required to pass along to the FDA.Commissioner Gottlieb told the committee that the FDA is careful about the decisions it makes and that there may be a higher tolerance for risk in situations where there is an unmet medical need, "so long as the patient is properly informed of what those risks are." This echoed what he told CNN's Dr. Sanjay Gupta in an interview earlier this month.The FDA previously told CNN that it was aware of Nuplazid's "complex safety profile" at the time of approval and required the drugmaker to place warnings on its labeling. The agency also said that, though it was continuing to monitor available information about Nuplazid, it had "not identified a specific safety issue" not already reflected on the medication's label.DeLauro's office told CNN that it plans to follow up with the FDA about its inquiry into Nuplazid. 7224

The Florida Highway Patrol said 30-to-40 vehicles have flat tires Monday morning on Interstate 95 northbound from Lantana Road to the Okeechobee Boulevard exit in West Palm Beach. The vehicles have flat tires due to metal debris in the road from a semi.All of the vehicles are off to the side of the interstate.Scripps station WPTV in West Palm Beach flew over the area and did not spot any lane closures, but traffic is traveling slow in the area.Drivers should avoid using I-95 northbound in this area until all of the debris is cleaned up.  596

The E.W. Scripps Company, based in Cincinnati, Ohio announced it has added two television stations to its business, bringing its current total to 35 stations in 26 markets.The stations purchased are ABC affiliates KXXV/KRHD in Waco, Texas, and WTXL in Tallahassee, Florida. Both were owned by Raycom Media."These two stations are strategic additions to our portfolio," said Brian Lawlor, President, Local Media."We have been interested in expanding into Texas for some time as we believe Texas will play an important part in U.S. politics moving forward," Lawlor said of the KXXV/KRHD purchase.Scripps owns WFTS in Tampa, WFTX in Fort Myers and WPTV in West Palm Beach, making WTXL its fourth in the state."The addition of Tallahassee will allow us to better cover the state's politics as we expand our reach beyond 50 percent of Florida’s television households," Lawlor said in a memo to Scripps employees.The announcement follows Scripps’ news Aug. 15 that it has completed the sale of its 34 radio stations for .5 million.Scripps' stations are affiliated with all of the Big Four television networks: ABC, NBC, CBS and FOX. The purchase of the two new stations adds 130 employees to The E.W. Scripps Company and brings it to 17 ABC affiliates. 1277

The day after a gunman who spewed anti-Semitic rhetoric allegedly?killed 11 congregants in a Pittsburgh synagogue, thousands mourned the dead, said their names out loud and proclaimed that hate wasn't welcome in their city.The crowd at the Jewish Family and Community Services of Pittsburgh's interfaith gathering and vigil spilled out of the Soldiers & Sailors Memorial Hall & Museum. Many stood in the drizzle outside during the ceremony.Less than two miles away, agents filed in and out of the site of the massacre: Tree of Life Synagogue, which houses three congregations. Authorities said Robert Bowers stormed the building early Saturday and killed the congregants gathered for Shabbat services in what the Anti-Defamation League has called the deadliest attack on the Jewish community in US history.At Sunday's service, the rabbis of the three congregations embraced after tearful tributes. Christian and Muslim leaders pledged to stand with members of the Jewish community. 1007

The coroner misidentified two of the Humboldt Broncos hockey players involved in a fatal bus crash, according to the Royal Canadian Mounted Police.Xavier Labelle, who was originally listed among the deceased, is actually alive, while Parker Tobin, who had been listed among the survivors, died as a result of the Friday collision, the RCMP said in a Monday news release."The Office of the Chief Coroner apologizes for the misidentification and any confusion created by it," the news release said. "The Coroner's office extends its deepest sympathies to the families and friends of those who lost their lives as well as those who were involved in the collision."At a news conference, a spokesman for the Saskatchewan Ministry of Justice said the young men involved in the crash were similar ages and builds, and the teammates had dyed their hair blond in solidarity for the Broncos' playoff run."A lot of these boys looked alike," Drew Wilby said.Dental records are the best way to ensure an identification is accurate, and it takes time to procure those records, especially considering some of the players hail from British Columbia, a province hundreds of miles to the west, the spokesman said."New information came to light last night that raised questions with the health care professionals," Wilby said, adding that the information was not related to dental records.Health care professionals were then able to correctly identify Labelle, and the Labelle and Tobin families were notified Sunday night, he said.The Labelle and Tobin families were involved in the initial identification processes, Wilby said, without elaborating.Citing Canadian privacy laws, Wilby declined to provide details of Labelle's injuries other than to say he is "an active patient in the system."After being informed that Labelle had died, brother Isaac Labelle told CNN he was at the gym when he got a text about the bus wreck. He called his father, an emergency room doctor, who had been en route to the game but had changed course to the crash site.Once there, Isaac Labelle said, his father told him that there didn't appear to be any survivors. Isaac Labelle went on to say his brother was "well-loved by everybody.""I also want people to know the good person he is," he said.The Labelle family could not be immediately reached to discuss the news that Xavier Labelle had been misidentified.Tobin is among the 15 killed in the crash in Canada's Saskatchewan province. The death toll includes nine other Broncos players, two coaches, two employees of a broadcasting company and the bus driver.The crash occurred around 5 p.m. Friday north of Tisdale, according to the Royal Canadian Mounted Police, as the team was headed for the town of Nipawin for a playoff game. RCMP Assistant Commissioner Curtis Zablocki said the tractor-trailer, traveling west on Highway 335, collided with the bus, which was traveling north on Highway 35.The cause of the crash is not known, and "the scope and complexity of this investigation means it will take some time to determine the cause of the collision and the circumstances surrounding it," said RCMP Assistant Commissioner Curtis Zablocki.The tragedy was felt across Canada, where hockey is the dominant sport and many young players take long bus rides to tournaments.Humboldt, a town of about 6,000, has a tradition of fielding teams in the Saskatchewan Junior Hockey League. The players, ranging in age from 16 to 21, come from different parts of Canada and stay with host families during the season, according to?the team's website."Our Broncos family is in shock as we try to come to grips with our incredible loss," Kevin Garinger, the team's president, said in a statement.The hockey community and others rallied around the victims and their families, offering financial assistance.By Monday morning, a GoFundMe page for the players and their families had raised more than .8 million, the result of about 70,000 donations. 3998