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FDA approves preventive Tamiflu for children

first_imgDec 27, 2005 (CIDRAP News) – The US Food and Drug Administration (FDA) gave its blessing last week to the use of the antiviral drug oseltamivir (Tamiflu) to prevent influenza in children between the ages of 1 and 12.The FDA had previously approved oseltamivir for treating (but not preventing) flu in that age-group and for both treating and preventing flu in adolescents and adults. Many countries are stockpiling the drug to prepare for a possible flu pandemic.In announcing its move, the FDA cited a study of the spread of flu in households. The study involved more than 1,100 people, including 222 children aged 1 to 12 years.When someone in the household came down with flu, other household members received either no treatment (unless they became ill) or oseltamivir once a day for 10 days. Three percent of those who received the drug contracted flu, versus 17% of those who received no preventive treatment, the FDA said.”The benefit in children mirrored the benefit seen in older individuals in this and earlier studies,” the agency said.The indicated dosage for preventive use in children is 30 to 60 milligrams per day, depending on body weight, for 10 days, according to Roche Pharmaceuticals, manufacturer of oseltamivir, a Swiss-based company with US headquarters in Nutley, N.J. Preventive use should begin within 48 hours after exposure to the virus, the company said.”The approval of Tamiflu in this indication enables doctors to have a safe and effective medicine at hand to help prevent young children from getting influenza,” said William M. Burns, CEO of Roche’s Pharma division, in a company news release. The company noted that children younger than 2 years are as likely as those over age 65 to be hospitalized if they get the flu.In studies, side effects of the prophylactic use of oseltamivir were similar to the side effects of treatment, the FDA said. The most common side effects were nausea, vomiting, headache, and fatigue. Vomiting was more common with twice-daily dosing than with once-daily dosing.”In the current study, children reported higher rates of vomiting than adults but this was observed to be dose-related,” the FDA said. No new side effects were seen in the study, but the agency has asked Roche for more post-marketing data on the safety of the drug.In November the FDA announced that a thorough review of post-marketing safety data on oseltamivir had revealed a few reports of severe rash and allergic-like skin reactions that might have been drug-related. As a result, the agency ordered that a new warning about the possibility of serious skin reactions be added to the drug label.In the same safety review, the FDA also examined reports of 12 deaths in Japanese children who were taking oseltamivir and concluded that the deaths were unrelated to the drug. The agency determined that the deaths were part of a wave of flu-related encephalitis and encephalopathy cases in Japanese children that began before oseltamivir was approved.See also:Dec 22 FDA news releaseDec 22 Roche news releaseNov 18, 2005, CIDRAP News story “FDA panel: children’s deaths unrelated to Tamiflu”last_img read more

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Suspended Jim Boeheim discusses 3-point shooting, Mike Hopkins and more on radio show

first_imgOn Tyler Roberson:“He got off-kilter. He’s not a great free-throw shooter, but he’s certainly not the kind of free-throw shooter based on that game (1-of-8 vs. St. John’s). I don’t know what happened. But he just, to me, he just didn’t play with confidence that you have to play with. He looked like he was going to miss it when he went to the free-throw line. He just didn’t look like he was confident. They basically were not guarding him too much. They were helping on the guards and Mike (Gbinije) and Trevor (Cooney). And he should score in those situations. That should be a big game for him.”On using the press:“We’ve pressed a little bit this year. But we’ve don’t got a lot of depth and that guy on the back line, Tyler Lydon, you’d like to have a shot-blocker back there. And he’s really not that kind of player. And you certainly don’t want people tagging him and getting him in foul trouble because we need him in the game. It’s hard to press. There’s not much pressing left in college basketball. Teams handle the ball pretty well and they can attack your pressure. If you to use it, we practice it all the time, so we have it. It’s not something we can count on in college basketball.” Sam Maller | Staff Photographer Facebook Twitter Google+ Syracuse head coach Jim Boeheim appeared on his weekly radio show on TK99 on Thursday night at Delmonico’s Italian Steakhouse. He is currently serving an NCAA-sanctioned nine-game suspension in which he cannot speak with anyone on the Orange (7-3). It was originally scheduled for only conference games, but was moved up to nonconference games after his appeal and is still suspended for six more games. He can still go on his radio show, however, and on Thursday he spoke about a number of topics, including the state of his team, the role of interim head coach Mike Hopkins and the recently retired Wisconsin head coach Bo Ryan.On 3-point shooting:“We have to shoot the ball. I laugh a little bit, I hear things and moving around and everything when you’re not working. Nobody was worried about us taking 3-point shots when we made them. Now that we miss them, they don’t want us to take them anymore. If we had an alternative to go to, then OK, let’s go and do this or that. We don’t have that alternative. We don’t have anybody that can score inside.”On Mike Hopkins:“He is a tremendous coach. He’s not coaching his team. He’s coaching my team. They’re used to my words and how I coach. When he has his own team and has four to five weeks to get them prepared, they’ll get used to his voice. Two days, they’re not going to get used to him. It makes it difficult for anyone to try and take over somebody else’s team. I don’t think it’s easier or in some cases possible to do.”AdvertisementThis is placeholder text“A dog herds sheep. You take that dog out of there and put a new dog in there and even if it’s a good dog, those sheep aren’t used to that dog.” On Bo Ryan’s retirement:“He was going to retire at the end of the year, and I think that’s always tough to do when you’re in the middle of it. I think he wanted to have his assistant to have a chance to coach. He’s been with him forever at two different schools. I don’t think the athletic director was giving the assistant the job so he figured this way the assistant would get to coach the rest of this year and prove what he could do. Something like what Kevin Ollie did and Kevin proved himself and got the job at Connecticut. And I think that’s what the hope is at Wisconsin. Bo Ryan did an incredible job taking that program to where they’ve never been.” Commentscenter_img Related Stories Syracuse basketball roundtable: Backup point guard, rebounding trouble and Mike HopkinsSchneidman: Why Tyler Lydon should be used moreDougherty: Syracuse, more than most teams, can’t afford to fall behind Sam Maller | Staff Photographer Published on December 17, 2015 at 9:20 pm Contact Sam: sblum@syr.edu | @SamBlum3last_img read more

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