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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 Federal Aviation Administration on Friday ordered new inspection requirements for engines similar to the one that failed earlier in the week on a Southwest Airlines flight, resulting in a passenger's death.The emergency airworthiness directive will require airlines to perform an ultrasonic inspection of certain CFM56-7B engines within 20 days of receipt of the order, it said. Federal safety investigators have said the naked eye cannot detect the cracks and signs of metal fatigue that doomed the engine on Southwest Flight 1380."We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design," the directive said.The Southwest Boeing 737 took off Tuesday morning from New York, headed for Dallas. About 20 minutes into the flight, at about 32,500 feet, a fan blade broke off the engine and shrapnel shattered a window.Jennifer Riordan, 43 and a mother of two, was sucked out of the broken window and pulled back inside by fellow passengers. She died from blunt force trauma at a hospital after the plane's emergency landing in Philadelphia.The new inspection is to be done while the engine is on the aircraft's wing. Inspections take between two and four hours per engine, according to the FAA and manufacturer.Friday's announcement came shortly after the engine manufacturer, CFM International, issued a service bulletin recommending the CFM56-7B engine be inspected more frequently. After reaching a certain age, the engines should be inspected approximately every two years, the manufacturer said.The manufacturer told CNN it has been working with the FAA on the inspection procedures.  1749

The Cheektowaga, New York mother whose battle with breast cancer captured the hearts of many Western New Yorkers has died. Libby Gaymon, 43, passed away Tuesday. She had faced breast cancer twice in less than two years.In May, Libby's daughter Alexis asked her mom to be her date to the senior prom at McKinley High School in Buffalo. The surprise promposal was a well-coordinated effort between Alexis, her family and McKinley administrators. Alexis wanted to bring her mother because Libby didn't get to go to the prom when she was in school.On prom night, dozens of supporters of Libby packed the Gaymons' front lawn, some spilling onto the sidewalk and neighboring lawns to cheer on the mother-daughter duo.McKinley High School donated a limousine, while other community members offered free wig services, makeup application and corsage supply to make the night even more special.Most recently, Gaymon tried an experimental immunotherapy treatment at Roswell Park. Immunotherapy helps the body’s immune system attack cancer cells. It is still being studied nationwide to see if it can play a role in treating metastatic breast cancer.   Her message she shared with Buffalo-based WKBW anchor Ashley Rowe in September was clear: slow down and take time to appreciate the world around you, or else you’ll miss everything.“You’re walking down the street on the phone, either you’re on the phone or you’re texting and you’re not even seeing your surroundings," Libby said. "You’re not seeing if you walk past flowers, or if you walk past somebody smiling back at you, but you’re too busy on your phone.  You guys are letting life pass you by.”  1681

The county of San Diego is preparing to ask the state for nearly million to repave stretches of hundreds of roads it maintains.The Board of Supervisors could vote Wednesday to seek revenue from the recent gas-tax hike to repair the roads. The roads are in all ends of the county, from Bonita to Alpine to Vista. You can see a list of the roads here (it starts on page 3)."The proposed projects will improve the overall condition of the roads and will protect roads from deterioration and costly future repairs," a county staff report said. Gov. Jerry Brown signed the billion gas tax hike into law last year. Californians already pay a series of gas taxes ranking among the highest in the nation. The tax hike raised the per-gallon tax by 12 cents last November, with future increases planned. The bill, SB1, also added a 0 fee to the annual registration for electric vehicles, starting with model year 2020."People can't afford it. I'm retired but if you're working and have to commute, I don't think people realize how much of a dent that's going to make," said Vicky Bamburger, a Bonita resident who is supporting an effort to repeal the tax that appears to be headed to this November's ballot.But those who support the increase say fixing the roads will save California drivers from expensive car repairs due to problems like potholes, and save taxpayers from larger repairs later."A small improvement now - if you have a road that needs to be covered - that's going to be so much more cost effective, cost saving in the long run," said Catherine Hill, of the League of California Cities.Local governments have until May 1 to submit their gas-tax revenue road repair requests to the state. Still, county agencies have already received millions of dollars in new revenue for road repairs, which includes major improvements to Interstate 5 in North County.  1892

The E.W. Scripps Company now has a reach of 21 percent of U.S. television households after purchasing 15 television stations.That brings the total number of stations for Scripps to 51. The purchase from Cordillera Communications was 1 million. It adds more NBC and CBS stations to Scripps' strong ABC roster.The Cordillera stations will significantly diversify the Scripps portfolio, growing it to 51 stations, including 18 ABC stations, 11 NBC stations, seven CBS stations and two Fox stations. Scripps will operate seven duopolies, efficiently enhancing the depth and durability of the portfolio.The stations Scripps is acquiring are: 652

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