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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 Collective Brewing project has teamed up with Lone Star Taps and Caps in Fort Worth, Texas to turn Easter's most polarizing treat—Marshmallow Peeps—into a craft beer. They plan to tap the concoction Friday, March 30 at 6 p.m. at the Taproom in Fort Worth, and they're calling the collaboration "Peep this Collab."On the website, the taste is described as tart and lemon-y and the look is described as a glitter bomb with fabulous sparkle. However, Ryan Deyo, Collective Brewing's head brewer and co-founder said drinkers could expect a "lightly tart" and marshmallow-y" taste from the beer on guidelive.Regardless of the flavor, Deyo said they mashed 30 boxes of peeps into a beer brewed with sour ale, vanilla and butterfly pea flowers (yes, actual flowers). If that doesn't sound delicious already, the beer will have purple tint thanks to the pea flowers and they will have edible glitter to up the sparkle content. This whole idea is a part of Deyo's passion to make beer for more fun."I've been on a kick to assert beer should be a fun thing," Deyo told guidelive. "We make a beer with ramen noodles, so Peeps isn't really a stretch."If Ramen Noodle beer sound just as good as peep beer, you're in luck, but neither of those flavors top the wackiest ever made by craft brewers. Flavors like Rocky Mountain Oyster, Oyster, Coconut Curry and Pizza beer have turned heads in the past.  1439

The first game on Thursday, which included arguably the top player in the nation, needed an extra five minutes to decide a winner. It was just one of many games that came down to a photo finish on Thursday.It is officially March Madness as first round action of the NCAA Tournament got underway.No. 7 Rhode Island 83 - No. 10 Oklahoma 78 (OT)The first game of the day was arguably the most exciting. Jeff Dowtin's attempt at a game-winning basket rolled off the rim for Rhode Island, but senior Stanford Robinson nearly put the rebound back into the rim at the buzzer. The missed buckets caused Rhode Island and Oklahoma to go to overtime tied at 69.  674

The chairwoman of the Republican National Committee, Ronna McDaniel, has tested positive for coronavirus, according to multiple reports.The New York Times reports McDaniel is experiencing mild symptoms and is quarantining in Michigan.She was last with President Donald Trump last Friday, and the NYT says she received her diagnosis on Wednesday. 353

The City of San Diego was awarded a million state grant that will help save food, save the planet, and save people.  The city will use a majority of the grant to convert its composting system at the Miramar Landfill into a closed system.  A news release from the city said that will reduce air emissions and continue to divert tons of food waste from the landfill.The City of San Diego currently keeps more than 100,000 tons of food waste out of the landfill by composting or making sure it’s diverted to food rescue non-profits before it’s thrown away.“It’s getting tossed because people don’t find the need for it or it’s got a slight cosmetic defect,” said Aviva Paley of Kitchens for Good, a food rescue that feeds hundreds of people a day by using food that could have been thrown away.“You can still make really good food with stuff that you just have to clean it up a little bit,” said Kitchens for Good Chef Trainer Theron Fisher.“It is so heartbreaking to see how much food goes to waste in this country,” said Paley.A portion of the state grant will allow Kitchens for Good to expand its operation.  It fed 35,000 people in 2016.  It would like to feed more than 50,000 by 2018.It would keep more food out of the landfill and feed more people who need meals.  Paley said one in six San Diegans go hungry every day.Another benefit for the Kitchens for Good program:  The cooks who prepare the meals are going through a 12-week training program to prepare them for culinary careers.  Paley said most of the participants have overcome obstacles from crime and drugs to mental disabilities.  The program opens them to a career they could otherwise never reach. 1718

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