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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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COVID-19 situation in Indonesia ‘under control’, Jokowi says

first_imgHe went on to say that Indonesia’s controlled mitigation of the ongoing pandemic was reflected in the rate of recoveries and active cases in the country.Read also: COVID-19 under control in Jakarta, Anies claims amid spike in new casesThroughout August, the recovery rate in Indonesia reached 72.1 percent, higher than the global average of 69 percent, he said.The country’s rate of active cases stood at 23.69 percent, lower than the global average of 27 percent, he added. Topics : However, the country’s 4.2 percent mortality rate is higher than the global average, which stands at 3.63, according to Jokowi.“Although we have reduced our fatality rate from 7.83 percent in April to 4.2 percent this month, we still have to do our work and further reduce it,” he said.Read also: Indonesia’s ‘Merah Putih’ vaccine candidate to be ready for production mid 2021: JokowiJokowi then called on every regional head across the archipelago to live up to their commitment to COVID-19 mitigation in their respective communities, claiming that public resilience was a key element prior to vaccination.“We need to improve our resilience, our endurance, until every citizen has been vaccinated,” he said.On Tuesday, the Health Ministry announced 2,775 new COVID-19 cases, bringing the total number of infections nationwide to 177,571. According to data released by the ministry, 88 more people have died from the disease, bringing the death toll to 7,505.center_img President Joko “Jokowi” Widodo claimed on Tuesday that COVID-19 mitigation in Indonesia has remained relatively “under control” compared to several other countries around the globe.“Compared to other countries, Indonesia remains under control. It needs to be maintained. COVID-19 mitigation is still at a point where it’s under control,” Jokowi said during a meeting at the Bogor Palace in West Java on Tuesday. The meeting was livestreamed on the Presidential Secretariat’s YouTube channel.The President, however, did not specify which foreign countries he was referring to in his statement.last_img read more

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Reds 2015

first_imgEven if the Reds go on a winning streak in September, there is little chance that they can move out of 4th place.  In fact, right now they are struggling to stay ahead of the Cubs.  A lot of questions need to be answered during the off season.Will they sign all of their top pitchers who are in the last year of their contracts?  They can probably get 3 or 4 good players/prospects for Cueto and/or Latos.  It will be very hard to give either of them the money they can demand on the open market.  They also have to decide who is going to play left field.  Will they give Heisey his chance or will they move Frasier to left field and play Negron at 3rd base?It does not seem that there are a lot of prospects in their minor league system.  Tucker Barnhart is the top prospect, but he is a catcher and they already have two good ones on the roster now.  There will be a lot of high-level meetings before Spring Training begins in February of 2015.  Another possible move is to get a new General Manager to replace Walt Jocketty.   We will have to wait and see.last_img read more

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