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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 first full slate of preseason games kicked off Thursday night, bringing NFL players back into the field for more football and more protests.Several players took a knee, raised fists or did not take to the field while the National Anthem was played before a dozen preseason games began across the country.The Miami Herald reported that Dolphins wide receiver Kenny Stills, along with wide receiver Albert Wilson, knelt during the anthem before a home game against Tampa Bay.WTVJ Miami reported that Dolphins defensive end Robert Quinn raised his fist during the song. 578

The Ebola outbreak in the Democratic Republic of Congo's North Kivu province claimed more lives as the country's Health Ministry announced on Thursday a new death in the city of Mabalako.At least 37 people have died so far in this latest outbreak, the 10th for country.Ebola cases have also been reported in the towns of Beni, Butembo, Oicha, Musienene and Mandima, according to Congo's Health Ministry.A total of 44 cases of hemorrhagic fever have been reported in the region, of which 17 are confirmed and 27 are probable, the ministry said in a statement Thursday. An additional 54 suspected cases are under investigation, the ministry said.On Tuesday, the World Health Organization confirmed that the latest cases in Congo's North Kivu province are part of the Zaire strain of the virus and that there is no link to a separate outbreak, which occurred in the western Equateur province that has since been declared over."It's good news and it's very bad news," WHO Deputy Director-General for Emergency Preparedness and Response Peter Salama told journalists in Geneva, after the new cases were first confirmed."The bad news is that this strain of Ebola carries with it the highest case-fatality-rate of any of the strains of Ebola, anywhere above 50% and higher, according to previous outbreaks," he said. "So, it's the most-deadly variant of the Ebola virus strains that we have, that's the bad news. The good news is that we do have -- although it's still an investigational product -- a safe and effective vaccine, that we were able to deploy last time around."According to WHO, this outbreak, which is in an active conflict zone, will be more complicated to contain than any that came before.Experts believe an experimental vaccine, known as rVSV-ZEBOV, made a difference in containing the earlier outbreak and vaccinations are under way in North Kivu, WHO said. A total of 3,220 doses of the vaccine are currently available in Congo and supplementary doses have been requested, WHO said.First line health workers, who had been in contact with people who were confirmed cases of Ebola, were the first to be vaccinated, WHO said."Vaccines are an important tool in the fight against Ebola," Congo's Health Minister, Oly Ilunga, said on Wednesday. "This is why it has been a priority to move them rapidly into place to begin protecting our health workers and the affected population."North Kivu province is among Congo's most populated provinces, with eight million inhabitants, according to WHO and UN. Its capital is the city of Goma. The region has been experiencing intense insecurity and a worsening humanitarian crisis, with over one million internally displaced people and a continuous outflow of refugees to neighboring countries, including Uganda, Burundi and Tanzania.WHO is working with partners in the local communities to provide information to residents on how to protect themselves from the deadly virus and answer their questions -- steps that are crucial to control an outbreak, said WHO.Congo's Health Ministry announced on August 1 that a cluster of new Ebola cases have been confirmed, just days after it declared an outbreak in Equateur province that claimed 33 lives had ended. That outbreak was the ninth recorded outbreak that Congo has seen since the virus was first discovered in 1976. 3324

The coronavirus continues to play havoc on college football teams throughout the United States as 15 Division 1 FBS games have been postponed or canceled for this weekend.Of the 15 contests, six involved AP Top 25 teams, including No. 1-ranked Alabama, No. 3 Ohio State and No. 5 Texas A&M. No conference has been impacted more than the SEC, which postponed four of its seven games scheduled for Saturday.The most anticipated matchup of the weekend, top-ranked Alabama versus defending national champion LSU, was postponed on Tuesday after LSU reported multiple COVID-19 cases.Maryland, who was scheduled to take on Ohio State, reported eight COVID-19 cases among its players.For schools with multiple coronavirus cases, a key issue is contact tracing and quarantining close contacts of those positive with the virus. The CDC recommends that anyone who has been within six feet for 15 minutes of someone infected with the virus to quarantine for up to two weeks.Texas A&M athletics direct Ross Bjork said contact tracing was a significant factor in postponing its game against Tennessee this weekend.“The nature of away game travel (flights, meals, lodging, locker room, etc.) naturally leads to an increase in the number of student-athletes, coaches and staff who meet the criteria for mandatory quarantine based on contact tracing guidelines,” Bjork said in a statement. “We are asking everyone around our university community to stay vigilant and follow all of the safety protocols and best practices as we approach the end of the fall sports seasons.”Here are the games postponed or canceled this weekend:No. 1 Alabama vs LSUNo. 3 Ohio State vs MarylandNo. 5 Texas A&M vs TennesseeNo. 12 Georgia vs MissouriNo. 15 Coastal Carolina vs TroyNo. 24 Auburn vs Mississippi StateMemphis vs NavyAir Force vs WyomingUL-Monroe vs Arkansas StateGardner Webb vs CharlotteNorth Texas vs UABRice vs Louisiana TechPittsburgh vs Georgia TechCalifornia vs Arizona StateUtah vs UCLA 1988

The Covid cases are getting out of control in CA. So we decided that we’re not doing a Christmas Eve party this year. It’s the first time we will not be having a Christmas Eve party since 1978 ??I believe. Health and safety first though! Taking this pandemic seriously is a must— Khloé (@khloekardashian) December 7, 2020 335