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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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Jakartans hit streets on first Car Free Day since start of PSBB, raising concerns of new outbreak

first_img“CFD in Jakarta has returned this morning,” @g_hanafiah tweeted.Another Twitter user, @adriansyahyasin, shared a series of photos showing a crowd of cyclists and joggers on Jl. Sudirman, while saying the lack of proper public spaces in the capital city had left most people with no other choice but to gather in a single location just to exercise.CFD yang ramai adalah bukti Jakarta tidak memiliki persebaran ruang publik terbuka berkualitas yang merata, sampe semua orang harus tumplek blek nunggu jalan ini ditutup atau ke GBK hanya untuk berolahragaKalo diseantero Jakarta jalannya aman buat bersepeda mungkin lain cerita pic.twitter.com/IQarnLHiw9— Adriansyah Yasin Sulaeman (@adriansyahyasin) June 21, 2020 “A crowded CFD proves that Jakarta lacks public spaces, so much so that everyone had to flock here […] or to the GBK [Gelora Bung Karno sports complex] just to exercise,” he wrote in the caption of the post.Fellow netizens have since conveyed their concerns about the risks of coronavirus transmission on CFD, with some even speculating that the weekly event could turn into a new outbreak cluster due to the lax implementation of physical distancing measures.It’s Car Free Day, not COVID free day, good people.— Raya Fahreza Wiguna (@rayafahreza) June 21, 2020 Netizens have raised concerns over public health as images and videos of large crowds inundating the streets of Central Jakarta on the first Car Free Day (CFD) following months of large-scale restrictions (PSBB) spread on social media.CFD had been suspended since March 15 as part of the city administration’s efforts to contain the spread of COVID-19.Internet personality and television host Gemala Hanafiah posted on her official Twitter page a video showing a large number of people walking and cycling near the Hotel Indonesia traffic circle on Jl. Thamrin on Sunday.CFD Jkt yg dah dibuka pagi ini pic.twitter.com/bKkeiY1Dzy— IG : @g_hanafiah (@g_hanafiah) June 21, 2020 “It’s Car Free Day, not COVID free day, good people,” @rayafahreza tweeted.Other Twitter users said that it was hard to blame residents for wanting to go outdoors.Satu sisi kayak takut bgt ga sih virus nya nyebar ke lebih banyak orang liat rame bgt gitu, tapi sisi lain mereka pasti udh bosen bgt dirumah, sekali nya cfd dibuka membludak org² nya, stay safe aja deh buat kalian disna.— lawmye (@huxleyycallum) June 21, 2020″One the one hand, I’m very worried that the virus will spread to many people seeing how big the crowd is, but on the other hand, they must be so bored at home,” @huxleyycallum wrote. The Jakarta Police have deployed personnel on Jl. Thamrin to ensure that residents obey health protocols such as wearing face masks and maintaining physical distancing.10.58 Kamsel Dit Lantas PMJ melaksanakan Giat Sosialisasi dan Himbauan untuk tetap menjaga kebersihan dan menerapkan protokol kesehatan di tengah warga Jakarta yg melakukan kegiatan CFD di BUndaran HI. pic.twitter.com/3TKY4I57xa— TMC Polda Metro Jaya (@TMCPoldaMetro) June 21, 2020Jakarta Governor Anies Baswedan said last Sunday that the administration would resume the weekly CFD. However, activities during the transitional PSBB period would be restricted to bicycle riding and outdoor exercise, with street vendors prohibited from operating.According to the official government count, Jakarta had 9,971 confirmed COVID-19 cases and 586 deaths as of Sunday.Topics :last_img read more

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