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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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Black Cats recall Wickham

first_img The 20-year-old, who has scored eight goals in 11 league appearances for the Yorkshire club, has returned to Wearside and could be involved in Wednesday night’s Barclays Premier League clash with Stoke at the Stadium of Light. A statement released on the Championship club’s official website, www.swfc.co.uk, said: “Connor Wickham has been recalled by parent club Sunderland, who have exercised the regular 24-hour clause in loan deals. Sunderland have recalled striker Connor Wickham from his loan spell at Sky Bet Championship club Sheffield Wednesday. Press Associationcenter_img “Sheffield Wednesday would like to thank Connor for his services and wish him well for the future.” England Under-21 international Wickham has struggled to make an impact in the north east since his £8.1million switch from Ipswich during the summer of 2011. However, he has impressed during his loan spell and has been linked with Nottingham Forest in recent weeks. Sunderland boss Gus Poyet has been monitoring Wickham’s progress at Hillsborough, but he has his own problems with summer signing Jozy Altidore in poor form and Steven Fletcher having scored only once in his last 16 appearances for the club. last_img read more

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Clock is ticking but Liverpool’s Klopp keeps dreams in check

first_img0Shares0000Jurgen Klopp refuses to bracket Liverpool with the European greats despite their rich Champions League pedigree © AFP / Paul ELLISMANCHESTER, United Kingdom, Apr 11 – Jurgen Klopp admits the clock is ticking on his target of winning a trophy within the first four years of his Liverpool tenure but after eliminating Manchester City he says he dare not dream that it will be the Champions League.The 50-year-old German refuses to contemplate a sixth European crown for the historic club even after they beat the runaway Premier League leaders 5-1 on aggregate in the quarter-final to reach their first Champions League semi-final for a decade. In his first season, Klopp guided Liverpool to the 2016 Europa League final where they lost to Sevilla but he is now contemplating a leap upwards in terms of quality of opposition.“I said (at his unveiling as Liverpool manager) if I sit here in four years probably we won something, otherwise it’s not possible,” Klopp told reporters after the 2-1 second-leg victory over Pep Guardiola’s team on Tuesday.“It’s now two and a half years and I still haven’t won anything so time is running.”Klopp, who guided Borussia Dortmund to the 2013 Champions League final where they lost to bitter German rivals Bayern Munich, says it is far too early to claim Liverpool can be the equals of European giants Bayern Munich and Real Madrid.– ‘We fought for each opportunity’ –Bayern and Real are potential semi-final opponents should they come through their quarter-finals unscathed on Wednesday. And a huge obstacle to all the teams’ chances of lifting the trophy was removed on Tuesday with AS Roma’s miraculous dismantling of Barcelona.“I have absolutely no interest in comparing us. Barca, Bayern, Real Madrid they win everything in the past 20 years,” said Klopp.“You don’t become a winner overnight.”Liverpool do of course have a rich Champions League history, most recently with the miraculous comeback in the 2005 Champions League final against AC Milan in Istanbul, although the Italians gained revenge in the final two years later.Klopp says his side are still a work in progress.A big step in that direction has come with his gamble to outlay a world record fee for a defender to acquire Virgil van Dijk. The Dutchman has added much-needed defensive solidity.“We can only develop,” said Klopp. “This competition is unbelievably strong.“I don’t care who is in (the draw), we are there and we deserved it and so far we fought for each opportunity to get it and then used it.“That’s what we will do (in the semis) but the other sides are not without their ambitions.”However, the laidback side of Klopp — he admits he finds time to be a bookworm — is reflected in how he felt he would have preferred to have watched the match.“You cannot imagine how much intensity you feel before a game like this,” he said.“Everybody wrote me a message: ‘I will watch the game here, there, I’ll have a beer together with friends’.“I would really like to do that as well sometimes, drink beer and watch a Champions League game. Unfortunately it is all work.”Come May 26 in Kiev he may at last be able to down a beer or three should Liverpool fulfil his personal ambition and restore the term European giants to their name.0Shares0000(Visited 2 times, 1 visits today)last_img read more

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