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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 Cameron Peak Fire is now the largest wildfire in Colorado's history. It grew overnight and is now 164,140 acres, but it remains 56% contained and no injuries have been reported.The fire became the largest in Colorado history Wednesday evening. It took only 48 days for the Cameron Peak Fire to surpass the 139,007-acre Pine Gulch Fire as the largest in recorded state history, and also blew past the 137,760-acre Hayman Fire in 2002.In a Thursday morning update, Operations Section Chief Paul Demerico of Rocky Mountain Team 1 said they are expecting a challenging few days ahead."But we have beefed up and feel like we have adequate resources to do what we can, especially when it comes to structure protection," he said.Several areas near the fire are under mandatory or voluntary evacuations as a result of the blaze. Highway 34 was also temporarily shut down in both directions between Loveland and Estes Park to help with evacuations, but has reopened.In addition, the Canyon Lakes Ranger District of the Roosevelt National Forest closed Thursday morning. This closure includes recreation sites — including all campgrounds — trails and Forest Service Roads.View the mandatory evacuations in the map below, or go here for the full list of evacuations and closures.Demerico said the western side of fire is almost all contained, but the fire was able to run east all the way to County Road 27 thanks to the wind, terrain and dry fuels.The main objective for the next day or so is to keep the fire south of 44H Buckhorn Road and west of County Road 27, he said.Winds will continue to be a problem over the next few days, Demerico said. Structure protection resources are scattered around Storm Mountain, Cedar Park, Glen Haven and Estes Park.The gusts also prevent fire officials from flying aircraft to help fight the blaze from the air.Larimer County residents may see periods of moderate to heavy smoke in their neighborhoods Thursday, according to the Colorado Air Quality Summary. The smoke may impact Fort Collins and Loveland as well.The National Weather Service said smoke from both the Cameron Peak Fire and the new East Troublesome Fire in Grand County will move toward Denver Thursday afternoon.The state's 10 largest wildfires in history, ranked by acreage, are:1. Cameron Peak Fire (2020): 164,140 acres2. Pine Gulch Fire (2020): 139,007 acres3. Hayman Fire (2002): 137,760 acres4. Spring Fire (2018): 108,045 acres5. High Park Fire (2012): 87,284 acres6. Missionary Ridge Fire (2002): 72,962 acres7. 416 Fire (2018): 54,000 acres8. Bridger Fire (2008): 45,800 acres9. Last Chance Fire (2012): 45,000 acres10. Bear Springs/Callie Marie fires (2011): 44,662 acresNote: The Rocky Mountain Area Coordination Center said the West Fork Complex fire, which burned a total of 109,632 acres in 2013, is not included on this list since it involved three separate fires.This story was originally published by Stephanie Butzer at KMGH. 2951

The FDA said in a news conference on Friday that there have been “roughly" five adverse reactions to Pfizer’s coronavirus vaccine, which began distribution earlier this week.According to FDA and Pfizer officials, 2.9 million doses of the vaccine was distributed this week. Those doses mostly went to health care workers and those living and working in assisted living facilities. It’s unclear exactly how many of those 2.9 million doses have been administered, as of Friday.Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, told reporters on Friday that one of the five adverse events caused a serious reaction. Marks did not go into detail on the locations or conditions of all the cases. The FDA has not responded for a request for additional information.Marks said that a case in Alaska was the most serious of the reactions being investigated.“We will continue to watch these closely. It is difficult to talk about them without any kind of good certainty until we have more information on them,” Marks said.FDA officials said that it’s possible the reactions were from the vaccine’s active ingredient polyethylene glycol. According to government information, the ingredient can cause known side effects such as bloating, diarrhea, nausea, cramps, gas and hives.FDA administrator Dr. Stephen Hahn said that the vaccine’s monitoring program is working well.“One of the things the FDA does well and uniquely is really getting to the bottom to events like allergic reactions,” Hahn said.On Friday, a second vaccine received FDA authorization. The vaccine from Moderna received an emergency use authorization, which means the vaccine can now be administered outside of a clinical or hospital setting. 1736

The Florida State Senate passed a bill Monday that would raise the age to buy a firearm from 18 to 21, require a three-day waiting period for most gun purchases and ban the sale or possession of bump fire stocks, which can make it easier for a semi-automatic weapon to function like an automatic rifle.The "Marjory Stoneman Douglas High School Public Safety Act" (SB 7026) would also give law enforcement more power to seize weapons and ammunition from those deemed mentally unfit or otherwise a threat and provide additional funding for armed school resource officers and for mental health services.The Senate measure comes more than two weeks after a gunman killed 17 students and teachers at Marjory Stoneman Douglas High School. Stoneman Douglas students and parents have lobbied lawmakers to pass stricter gun control measures.The bill now moves to the Florida House. It's not immediately clear when the House will take up the measure. 948

The E.W. Scripps Company is a partner with The Associated Press and has been following guidance from their election desk on 2020 race updates.From Wednesday through Saturday, Joe Biden had a projected total of 264 Electoral College votes, six shy of the number needed to become president. As Election Day ground on into “election week,” it became increasingly clear that Biden would oust President Donald Trump from the White House. The question, rather, was where he would win, when it would happen and by how much, as late counted ballots in Nevada, Pennsylvania and Georgia continued to keep Biden in the lead and offered him multiple paths to victory. On Saturday, Biden captured the presidency when The Associated Press declared him the victor in his native Pennsylvania at 11:25 a.m. EST, garnering the state’s 20 electoral votes, which pushed him over the 270 electoral vote threshold needed to win. 914