吉林肚子左下角疼是怎么回事(吉林如何治疗阳痿和早泄) (今日更新中)

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 large head-to-head comparison of two opioid addiction medications found that, although they were equally effective in getting people off of high levels of opioids, users had a significantly more difficult time starting a regimen of naltrexone, compared with buprenorphine.Buprenorphine is commonly known by the the brand name Suboxone, and naltrexone is sold under the brand name Vivitrol.The study, published Tuesday in the Lancet, looked at 570 patients with opioid addiction at eight inpatient treatment centers across the country for 24 weeks. Half of the group was assigned to naltrexone and the other half to bupenorphine.Six percent of those enlisted to use buprenorphine were unable to start their treatment, whereas 28% of those assigned to naltrexone dropped out before starting the therapy. 824

The Department of Justice on Monday filed complaints against 11 individuals believed to be members of the?Central American migrant caravan, accusing them of illegally entering the United States.After a month-long journey by bus, train and on foot, about 100 migrants arrived at the San Ysidro port of entry on the US-Mexico border on Sunday evening, preparing to claim asylum. About 20 to 30 migrants spent the night inside an immigration processing center in Tijuana, Mexico.An organizer of the caravan vowed they would remain at the immigration processing center until "every last one" is admitted into the United States.Two Salvadorans, six Hondurans, and three Guatemalans face charges, a federal law enforcement official told CNN.Ten of them face a misdemeanor charge for allegedly entering the US illegally. Another individual is alleged to have entered the country after they were previously deported, and faces a felony charge.The probable cause statement alleges many of those charged were seen in an area known as Goat Canyon, about 4 miles to the west of the San Ysidro port of entry, on the US side of the border, the official said. Others were seen on the US side of the border about 2 miles west of San Ysidro in an area known as "W-8." 1263

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 Florida Senate race is headed to a hand recount after a machine review of the initial vote kept Democratic Sen. Bill Nelson narrowly behind his challenger, Republican Gov. Rick Scott.But even though a recount will keep Nelson in the fight for at least another few days, his odds of winning might have been further narrowed on Thursday, when the machine recount — which ended at the 3 p.m. deadline — yielded a few dozen more votes for Scott, whose lead now stands at more than 12,600, or 0.15%.The race for governor remained outside the 0.25% margin required for a hand recount, meaning Republican former Rep. Ron DeSantis will likely be the state's next chief executive over Democrat Andrew Gillum. The Tallahassee mayor, who picked up a single vote in the recount, revoked his concession last weekend and said on Thursday he would continue to push for all votes to be counted.Election boards across the state have been using voting machines to recount ballots this week, with some of the larger counties working all day and through the night. When Thursday's deadline hit, three statewide races -- the contests between Nelson and Scott for Senate; Gillum and DeSantis for governor; and Republican Matt Caldwell and Democrat Nikki Fried for agriculture commissioner -- were within the .5% margin required for a statewide machine recount.Both the Senate and agricultural commissioner races are now headed to hand review of overvotes and undervotes, a more narrowly circumscribed but also potentially volatile pool of votes. These are ballots where the voter appeared to tick off more candidates than allowed (overvotes) or on which they voted for fewer candidates than allowed (undervotes).Palm Beach County failed to meet the recount deadline, meaning last week's unofficial count out of Palm Beach County is the one that it will take into the next phase of recounts.Hours before the machine recount cutoff, a federal judge in Tallahassee rejected a Democratic motion to extend the deadline beyond 3 p.m.Nelson's campaign and the Democratic Senatorial Campaign Committee had argued that all recount deadlines should be lifted for however long the counties determined necessary to conclude their work."The Florida legislature chose to define emergency narrowly -- only as an event that results or may result in substantial injury or harm to the population or substantial damage to or loss of property," Judge Mark Walker wrote in explaining his decision. "The emergency exception does not apply in this case, where the delay is the result of outdated and malfunctioning vote-counting technology."Palm Beach County has been hampered repeatedly by faltering machinery and shoddy infrastructure.Susan Bucher, the county's supervisor of elections, told reporters on Thursday she would take "full responsibility" if the county failed — as it eventually did -- to meet Thursday's deadline."It was not for lack of human effort ... it was so incredible, and I thank everybody who participated," she said. Bucher had told reporters a little more than 24 hours earlier that she was in "prayer mode." That seemed to be an upgrade on her predictions from earlier in the week, when on Sunday, hours after the recount began, she said that completing it on time would be "impossible."Bucher's worries were compounded on Tuesday when the county's old and overheated machines malfunctioned, forcing officials to start their recount of early votes from scratch. By Wednesday, the already distant hopes of an on-time finish seemed to be slipping away.CNN observed long stretches of inaction on the floor of the cavernous facility which has been occupied by reporters, lawyers and operatives from both parties, and volunteers who have been working -- when the hardware complies -- day and night."It's an unusual request to make of your staff. You know, can you leave your kids behind, stay here and I'll feed you sub sandwiches and pizza and you'll work your brains out," Bucher said on Wednesday. "We're trying to meet a deadline that really reasonably shouldn't be there."But the court disagreed and a spokeswoman for the Florida Department of State told CNN on Sunday that Florida law does not give the secretary of state the authority to grant extensions.Palm Beach County GOP Chairman Michael Barnett told CNN on that afternoon that a blown deadline would be "good news for Republicans, because our candidates (for Senate and governor) are ahead.""If they're not able to meet the deadline, the secretary of state of Florida may go ahead and certify the elections for our candidates," Barnett said. "In that case, you can bet your butt there will be lawsuits filed everywhere."The wager would have been a wise one. Democratic attorney Marc Elias announced new legal action on Twitter less than 90 minutes after the deadline passed."We have sued Palm Beach County and the Florida Sec of State to require a hand count of all ballots in the county due to systematic machine failure during the machine recount," Nelson's top recount lawyer said.Barnett, who was inside the facility along with Democrats early on in the recount, was critical of the infrastructure there from the start."It's an outdated process," he said. "The machinery is old. They don't have enough updated machinery to go through all the ballots to run one election, let alone all three statewide races."As of 4 p.m. Wednesday, at least 48 of Florida's 67 counties had finished their recounts. Every one of them reached by CNN, with the exception of Palm Beach, expressed confidence they would get in under the wire — and they mostly did. Hillsborough County said it did a full machine recount but chose to report its initial numbers, which were higher in aggregate, because the figures were so similar.Meanwhile, a federal judge Thursday denied a request by lawyers for Nelson and other Democrats who has asked him to compel Florida's secretary of state to release the names of people whose ballots had not been counted because their signatures did not match ones on file.Judge Mark Walker took a dim view of how the Democrats and Republicans might put the information to work."I am not going to be used by either party," Walker told the lawyers. "That's the kind of gamesmanship that would undermine our democracy further."This case has been appealed to the 11th Circuit by lawyers for Scott, the secretary of state and others.Mark Early, the Leon County supervisor of elections, testified in an earlier hearing on a different case about the vote by mail process, that he could count the late ballots in about four hours. But said there would be an increased burden on his staff.Walker did not rule in the case, which could allow vote-by-mail ballots received after the deadline be counted. 6753

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