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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 Center for Disease Control (CDC) has issued a reminder to the public to stop washing and reusing condoms.The CDC said in a tweet that this reminder to all sexually-active Americans was sent out "because people do it." 229

The family flick "Show Dogs" is getting an immediate re-cut after parents who took their children to see the movie criticized scenes they say depict sexual abuse.The edits address scenes in which the lead undercover police dog Max, voiced by Ludacris, who while being inspected at a dog show becomes comfortable with his private parts being touched, according to Deadline.In a statement, Global Road Entertainment said the revised version of the film will be in theaters this weekend:  508

The current pandemic has led many people to spend more time outside this summer, with many setting up backyard pools or heading to lakes and beaches. But all of that water recreation has led to a spike in drownings."We were seeing it across a national level and when we looked at our local data, we saw that we were following as part of that trend," said Dawne Gardner, an Injury Prevention Specialist with Cincinnati Children's Hospital. Normally, they see anywhere from one to three child drowning deaths a year. This summer, they've seen nine."We know that with parents, they're looking for alternative vacations and things are limited right now with COVID-19 and still being able to social distance. We know that with those limited options, parents are utilizing backyard pools more," said Gardner. Gardner says it may seem safe to have your child swimming in your backyard but she says safety goes way beyond location. Supervision is key."You can't be distracted. So, when kids are in and around water, parents have to be on top of the supervision. Every second counts. And if you take your eyes off of them in the water even for a second, that could be that quiet second that a child slips under water," said Gardner.Other areas of the country also saw a dramatic change in the number of child drownings, but not all were bad. Johns Hopkins All Children's Hospital in St. Petersburg, Florida reported that from March through June, doctors saw a 150 percent increase in child drownings and near-drownings compared to the same time period last year. While at Valley Children's Hospital in Fresno County, California, officials reported a sharp decline in child drownings. The shelter-in-place restrictions from the COVID-19 pandemic don't just prompt families to take part in more water-related activities, they did so at a time when most swimming lesson facilities had to shut down.It was a concern for Aqua-Tots that kids were missing out on a crucial time for swim lessons. "It was incredibly hard to close the doors to our businesses at such a crucial time of year where families and children are outside in the heat and they're flocking to bodies of water. They're swimming a lot more often so it was very tough," said franchise owner Lindsay Thayer of Aqua-Tots. Aqua-Tots has 100 locations in 14 different countries, including here in the U.S. They teach swimming lessons to children, teens and adults. Thayer says to help prevent accidental drownings, children need to learn water safety."Children need to know that they need to ask permission, when to approach a body of water, when to get into a pool or lake with mom or dad, a guardian or adult before doing so. Also, swim lessons are especially important. Participating in a formal swimming lesson program can reduce the risk of drowning by 88% in children between the ages of one and four," said Thayer.Jen Deis, the General Manager of Goldfish Swim School near Cincinnati agrees. Goldfish Swim School provided some online tutorial videos for parents to help them teach their children some basic swimming skills. But she says swim lessons, even during the winter, are vital."Swimming is like any other sport or skill. Kids need constant reinforcement of those swim skills to remember those water safety skills year round. While, right now it is a top priority, with kids around bodies of water a lot of times, keeping them consistent in their swim lessons is really important," said Deis.Cincinnati Children's Hospital reports the nine drowning victims ranged in ages from young children to teenagers. Ensuring fences or other barriers are around pools is also important.They're urging parents to be vigilent when it comes to keeping your children safe around water, hoping to prevent any more accidental drowning deaths this summer. 3807

The cremated remains of notorious cult leader Charles Manson were scattered on a California hillside following a Christian funeral on Saturday, nearly four months after his death.The burial came one week after Manson's grandson, Jason Freeman, won the right to his grandfather's body after a court battle that began shortly after Manson's death on November 19.The family "acted like ninjas" to keep the funeral in Porterville, California, from gaining attention, Freeman said.About 20 people attended, he said, describing them as his grandfather's best friends from before and during Manson's 46-year incarceration.Among them was Sandra Good, a member of the original "Manson Family." Good was not part of the grisly two day killing spree that terrorized the nation in 1968. But she remained a follower and extolled Manson's environmental directive known as Air, Trees, Water, Animals (ATWA).Manson's body was dressed in an orange ATWA T-shirt for the funeral. His remains were cremated after the service.Also attending was Afton Burton, who was briefly Manson's fiancée in 2014. She was 53 years younger than Manson.Freeman battled two other men with Manson connections for the right to dispose of the remains -- Michael Brunner, who claimed to be Manson's son and Michael Channels, a long time Manson friend and memorabilia collector. Freeman invited both to the funeral. Neither showed up.During the court fight, both Freeman and a probate attorney talked about Manson's body being kept "on ice" by the Kern County Coroner. However, Freeman told CNN that the funeral home told him they "had a mess on our hands," and that there was "gross neglect to the corpse." Freeman said it was clear to him that his grandfather had not been properly stored.But Stephen Wells, a spokesman for the Kern County Sheriff's department, said that Manson's body "wasn't treated any differently than any other body" being stored by the coroner's office. Wells said it was kept refrigerated, and that "after four months it would have the standard decomposition."Freeman is a devout Christian, and had a local pastor from Porterville lead the service.Also at the service was a documentary camera crew working with Freeman on a film about his father -- Charles Manson Jr., who committed suicide when Jason was a boy.While the fight over Manson's remains is over, the court battle for his estate -- including personal items as well as music rights -- is still being fought in court. Freeman, Brunner, Channels and Matthew Robert Lentz, who also claims to be Manson's son, all head to probate court in Los Angeles again on Friday."It was great for everybody to come together for the first time," said Freeman's wife, Audrey, who accompanied him to the funeral. "It was a gift to us."  2775