Dec 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”
Three English clubs are in this morning’s draw for the last-16 of the Champions League.Chelsea are the only one of them who are among the top seeds – so they’ll get an easier tie in theory.Manchester City and Arsenal face a tougher draw against the likes of holders Real Madrid and Barcelona. English teams can’t be drawn against each other, nor can they meet anyone they played in the group stage.Everton are the only one of four British clubs seeded in this lunchtime’s draw for the last-32 of the Europa League.They finished top of their group.Merseyside rivals Liverpool dropped out of the Champions League and into the unseeded pot, along with Tottenham and Scottish Premiership leaders Celtic.
Ghanaian striker, Raphael Dwamena has completed his loan move to Real Zaragoza in a season long loan from UD Levante.The Black Stars striker played just 15 matches in the 2018-2019 season for Levante where he had just one assist and no goal to his name.The 23-year-old moved from FC Zurich to La Liga after an impressive season in Switzerland scoring 21 goals in just a year.The striker made his first Black Stars appearance in 2017 has scored two goals in three appearances.Speaking at his unveiling on Wednesday, Dwamea indicated his willingness to play his part in helping the team succeed in the coming season.“Real Zaragoza is a huge club with history and I want to help the team meet its objectives and go to the Primera Liga.The Segunda is a tough league but for me, the most important thing is to help the team and work hard at all times.”Dwamena will be handed jersey number 9 for coming season.