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The US surgeon general issued an advisory Thursday recommending that more Americans carry the opioid overdose-reversing drug, naloxone.The drug, commonly known as Narcan, can very quickly restore normal breathing in someone suspected of overdosing on opioids, including heroin and prescription pain medications.Dr. Jerome Adams emphasized that "knowing how to use naloxone and keeping it within reach can save a life." To make his point, Adams relied on a rarely used tool: the surgeon general's advisory. The last such advisory was issued more than a decade ago and focused on drinking during pregnancy.Adams noted that the number of overdose deaths from prescription and illicit opioids doubled in recent years: from 21,089 deaths across the nation in 2010 to 42,249 in 2016.America's top doctor attributed this "steep increase" to several contributing factors, including "the rapid proliferation of illicitly made fentanyl and other highly potent synthetic opioids" and "an increasing number of individuals receiving higher doses of prescription opioids for long-term management of chronic pain.""Research shows that when naloxone and overdose education are available to community members, overdose deaths decrease in those communities," Adams said. Naloxone is used by police officers, first responders and emergency medical techs to reverse opioid overdoses. Adams added that increasing both the availability of naloxone and effective treatment is critical to ending the opioid epidemic.Speaking at the National Prescription Drug Abuse & Heroin Summit in Atlanta on Thursday morning, Adams addressed the potential "moral conflict" felt by some people who believe that providing naloxone "doesn't make a difference," since many people with drug addictions will just "go on and misuse substances again.""Well, that would be like me saying 'I'm not gonna go do surgery on this trauma patient because they're just gonna go out and speed again,' " he said.Adams noted that in most states, people who are or who know someone at risk for opioid overdose can get trained to use naloxone properly and also may receive naloxone by "standing order" -- without a prescription -- from pharmacies or some community-based programs."No mother should have to bury their child ,and especially not when there's a life-saving medication that virtually anyone can access," Adams said. "It is for this reason that I am issuing the first Surgeon General's Advisory in 13 years."The-CNN-Wire 2484

The US Food and Drug Administration expanded?the list of drugs being recalled that contain valsartan. The drug is used as a component in a set of drugs used to treat heart failure and blood pressure.New to the list are some valsartan products manufactured by Hetero Labs Ltd. in India, which are labeled as Camber Pharmaceuticals Inc. Test results show that some of the products may be tainted.The FDA announced a valsartan recall in July after lab tests revealed that some drugs could have been tainted with a substance linked to higher risk of cancer. The drug had been recalled in 22 other countries. The expanded recall includes some drugs that contain valsartan and hydrochlorothisazide. Not all of the drugs containing valsartan were affected.N-nitrosodimethylamine or NDMA, the impurity the lab tests found, is considered a?possible carcinogen by the US Environmental Protection Agency. It is an organic chemical that has been used to make liquid rocket fuel, and it can be unintentionally introduced through certain chemical reactions. It's a byproduct of the manufacturing of some pesticides and fish processing.The medicines that are now a part of this expanded list?in the recall are tablets sold by AvKare, A-S Medication Solutions LLC, Bryant Ranch Prepack Inc, Camber Pharmaceuticals, Inc. H J Harkins Company, Northwind Pharmaceuticals, NuCare Pharmaceuticals Inc., Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC), Proficient Rx LP, Remedy Repack, Teva Pharmaceuticals (labeled as Major Pharmaceuticals), Teva Pharmaceuticals USA (labeled as Actavis).The FDA also published a list of valsartan products that are not currently recalled. Only the drugs suspected of being tainted with NDMA are on the recall list. If you are taking a valsartan drug, look for the company name on your prescription bottle. If the information isn't on the label, you can call your pharmacy for those details.The recalled medicine is linked to a manufacturer in China. The substances were supplied by Zhejiang Huahai Pharmaceuticals, based in Linhai, in eastern China, which said it notified authorities as soon as it identified the impurity."We published our recall notice at midday on July 13 in China and overseas, and published the US market recall notice on July 14 Beijing time ... all the drug materials for the Chinese market were recalled by July 23," the company said in a statement to the Shanghai stock exchange last month.The FDA said on its website that it's working with drug manufacturers "to ensure future valsartan active pharmaceutical ingredients are not at risk."If you are worried that your drug could be on the recall list, talk with your doctor or pharmacist before changing any routine with your medicine. Because not all valsartan drugs are involved in the recall, they might be able to switch you to a version of the drug made by another company.If you know your drug is on the recall list, the FDA suggests you continue taking it until your doctor or pharmacist provides a replacement.To get a sense of what taking a tainted drug could mean, FDA scientists estimated that if 8,000 people took the highest dose of valsartan (320 milligrams) from the recalled batches every day for four years, there may be one additional case of cancer."The key with this is, patients should not stop taking their medication abruptly, that definitely can be harmful," Dr. Mary Ann Bauman, a representative for the American Heart Association, said in July. "You don't want to jump to any conclusions on your own about this medication, or any medication for that matter. Definitely talk with your doctor first." 3690

The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 6274

The Sarasota (Fla.) County School District confirmed they are looking into a racially offensive promposal that was posted to social media.A spokesperson for the district confirmed the Riverview High School senior posted a picture that they worry will be a disruptor to the school and student safety. The post made to Snapchat reads, "If I was Black I'd be picking cotton, but I'm white so I'm picking U 4 Prom?"The district said they have not concluded if the 18-year-old will be banned from prom as it's an ongoing investigation. Sarasota County Schools also said they sent a text alert to parents Monday morning about the situation and that they plan to have more information late Monday. The student, who Scripps station WFTS in Tampa is not identifying, also posted an apology to social media. The following message was sent to parents and students on Monday morning:  930

The US officially relocated its embassy to Jerusalem on Monday, formally upending decades of American foreign policy in a move that was met with clashes and protests along the Gaza-Israeli border.Here is what we know: 225

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