FDA panel seeks stronger label warnings for 2 flu drugs
Nov 27, 2007 (CIDRAP News) – The US Food and Drug Administration’s (FDA’s) Pediatric Advisory Committee voted today to recommend stronger label warnings for two antiviral influenza medications—oseltamivir and zanamivir—that have been linked to reports of neuropsychiatric problems in children and teens, mainly in Japan.Oseltamivir already carries a warning, but zanamivir currently carries no warning about reported neuropsychiatric effects.”Anything that elevates awareness is probably not a bad call,” said committee member Michael Fant, an associate professor at the University of Houston Medical School, according to a Bloomberg News report published today.The FDA typically follows though on the recommendations of its advisory committees, though it is not required to do so.In briefing materials posted on the FDA’s Web site in advance of today’s meeting, the committee said it is unclear if the two drugs play a role in reported neuropsychiatric events, but because reports of adverse effects are still occurring, labeling changes are needed for both drugs to urge healthcare providers to monitor children closely when they begin taking the medications.”While there have not been noticeable changes in the types or pattern of neuropsychiatric AEs [adverse events] reported in association with the use of Tamiflu, the number of cases continued to increase,” the committee wrote in reference to the last flu season.Oseltamivir and zanamivir are neuraminidase inhibitors, used both to prevent and to treat seasonal flu. Oseltamivir is considered the most promising available drug for dealing with a potential pandemic influenza strain. The United States and many other countries are stockpiling it because of the pandemic threat. Zanamivir is a powder that is inhaled by mouth with a “Diskhaler” device.Since 2005, US regulators have been concerned about reports of self-injury and delirium linked to oseltamivir in children and adolescents from Japan, where use of the drug is much more prevalent than in the United States.Today’s meeting is the FDA’s third review of oseltamivir’s reported neuropsychiatric events. At the first meeting, in November 2005, the committee concluded that the deaths of 12 Japanese children were not related to their use of the antiviral medication. The committee said it would monitor adverse-event reports over the next two flu seasons to determine if further precautions are needed.In November 2006, the advisory committee said it still found no evidence that the oseltamivir contributed to the neuropsychiatric events, but it recommended a labeling change to reflect the increasing number of reports, which included a small number of patients from the United States. Roche, the maker of oseltamivir, revised the drug’s packaging insert.Several theories have been proposed about why reports of neuropsychological effects in children who have taken the drug are much more common in Japan than elsewhere, according to the committee’s recent briefing report. Reasons could include differences in the rate of oseltamivir use, methods of adverse-event reporting, and manifestations of the disease in Japan as compared with the United States.The FDA said that as of May 31, 2007, it had received reports of 25 deaths from all causes in patients aged 21 or younger who were taking oseltamivir. Twenty-one were in Japan, three occurred in the United States, and one was in Egypt. Five of the deaths, all from Japan, involved adolescent patients who died after falling from windows or balconies or running into traffic.Meanwhile, GlaxoSmithKline, the company that produces zanamivir, said in its briefing report to the FDA that the company received 145 reports of neuropsychiatric events associated with zanamivir during the 2007 flu season, all from Japan. Nearly all (99%) were reported in children and adolescents aged 6 to 14 who had flu or flu-like illness. None were fatal.The increased reports of neuropsychiatric events in young people who took zanamivir coincided with a warning issued by Japan’s health ministry about abnormal behaviors in Japanese youth who took oseltamivir, Glaxo wrote in its report to the FDA committee. Japan also had a fivefold increase in zanamivir use over the past 2 years, the company added.Both Roche and Glaxo said in their reports that they don’t believe the evidence warrants labeling changes. However, Roche spokesman Terry Hurley said the company would be “open” to considering a labeling change if the FDA thinks more details should be added, the Washington Post reported on Nov 24.See also:Roche briefing informationRelenza briefing informationFDA advisory committee background summaryNov 14, 2006, CIDRAP News story “Tamiflu may pose risk of mental side effects”
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Topics : The return of Barcelona’s embittered captain and greatest ever player may not be an easy one, particularly given some of his closest team-mates are likely to leave.Luis Suarez, Messi’s best friend and neighbor, as well as Arturo Vidal, are expected to join Juventus and Inter Milan respectively. “Now I don’t know what will happen,” Messi said on Friday.”There is a new coach and new ideas. That’s good, but then we have to see how the team responds and whether or not it will allow us to compete at the top level. What I can say is that I’m staying and I’m going to give my best for Barcelona.” Lionel Messi returned to Barcelona training for the first time on Monday since his failed attempt to leave the club this summer.Barca confirmed Messi has started by training alone, in line with La Liga protocol.”The 2020/2021 preseason is under way for Leo Messi,” the statement read. “The Barca number 10 trained on his own, as did [Philippe] Coutinho, according to La Liga protocol whilst the rest of the squad worked out together.” Messi was seen driving into the Ciutat Esportiva and Barca posted a photo on social media just before 6:30 pm (1630 GMT) of him training in kit and working with a ball.The 33-year-old was taking part in his first session since Ronald Koeman was appointed coach and his first since he said on Friday he had been forced to stay at Barcelona.In an explosive interview with Goal, Messi blamed the club’s president Josep Maria Bartomeu for “breaking his word” over a much-disputed exit clause in his contract.He said he would continue to give his best for the team but maintained he had tried to leave the club because he “wanted to live his last years of football happily”. Long-term future in doubt Messi’s decision to notify the club via burofax that he intended to leave came shortly after he met with Koeman, talks that reportedly involved the Dutchman taking a hard line. Koeman said in his first press conference he “only wanted players who want to be here and give everything”.Messi also refused to attend either a coronavirus test or Koeman’s first week of pre-season training last week, as his lawyers believed participating would harm his case in a potential legal battle with the club.But Messi opted not to go down that route, insisting he could never go to court against “the club of my life”.Yet his long-term future remains in doubt given Messi can talk to other clubs in January and leave for free when his contract expires on June 30.Messi could feature in Barcelona’s friendly against Gimnastic Tarragona on Saturday but a more realistic reintroduction might be against Girona four days later.It would be the first time he has played for the team since their historic 8-2 defeat by Bayern Munich in last month’s Champions League quarter-finals.Barcelona have been given an extra two weeks off to recover before they start their La Liga season against Villarreal, scheduled for September 27.
Achmea IM saw its assets under management increase from €116bn to €120bn, in part as a result of new pension fund clients for its general pension fund, Centraal Beheer APF.With AuM of €1.1bn, the general pension fund is now the third biggest in the Dutch market.Achmea said it had launched new user portals for both employers and workers for the Centraal Beheer APF as well as for the company pension funds.In 2016, Achmea’s pensions arm reported a loss of €22m. At the end of that year the company announced that it would cease its services to mandatory industry-wide pension funds within two years, as its IT systems could no longer cope with the multitude of pension arrangements.In July last year Wonen, the scheme for the Netherlands’ furnishing industry, was the last of Achmea’s 22 sector clients to confirm its new pension arrangements.The group later removed the ‘Syntrus’ brand from its business.During the presentation of Achmea’s first half figures in August last year, chairman Willem van Duin predicted that pensions management would deliver a profit soon as a result of the decision.It said it would complete the service provision to mandatory sector schemes during the first six months of 2018, by guiding them to other providers under the old name of Syntrus Achmea Pensioenbeheer, which is to disappear subsequently.For 2017, Achmea improved its overall operational result from a loss of €319m to a €349m profit, largely as a result of contributions from its divisions for damage and income insurance as well as pensions and life insurance.As of 1 January, Achmea brought its services to company pension funds, occupational schemes, non-mandatory pension funds as well as the Centraal Beheer APF under the new umbrella of Achmea Pensioenservices. Within Oudedagsvoorzieningen, Achmea Pensioenservices aimed to grow through “innovative digital service provision”. Achmea’s decision to abolish its service provision to the Netherlands’ mandatory industry-wide pension funds contributed to its first profit from pensions management in a decade.The Dutch bancassurer’s annual figures for 2017 showed that its newly established ‘Old Age Provisions’ (Oudedagsvoorzieningen) business unit – which also includes Achmea Investment Management and Achmea Bank – improved its operational result to a €12m profit, following a loss of €18m the previous year.Since the establishment of Syntrus Achmea Pensioenbeheer in 2008, this part of the business had incurred annual losses varying from €10m to €40m, in particular relating to its services to mandatory sector schemes.Achmea attributed the improved result to all parts of Oudedagsvoorzieningen, adding that Achmea Bank had driven down its costs by €20m to €266m.
International law firm Pinsent Masons has been appointed to the new German advisory panel of Danish offshore wind farm owner and developer Ørsted.Pinsent Masons will support Ørsted’s ‘Customer Solutions’ activities in Germany in the areas of commodities and energy trading. Dr Thorsten Volz, Head of German Energy at Pinsent Masons, said: “Ørsted is a long-standing client of Pinsent Masons’ UK practice. This panel appointment is a great success for the firm and underlines the success of its German energy law practice, which was established in Düsseldorf in 2016. Thanks to our excellent positioning in the field of energy law, we are able to advise on all energy, corporate, contract and regulatory issues.”Ørsted currently operates three offshore wind farms in the German North Sea, Gode Wind 1&2 and Borkum Riffgrund 1. After the commissioning of the company’s fourth offshore wind farm in Germany, the 450MW Borkum Riffgrund 2, in 2019, Ørsted will have over 1.3GW of operating offshore wind capacity in the German North Sea.The company has also secured rights to develop further five projects in the German North Sea by 2024/2025 with a combined capacity of 1,141.75MW.Focusing on offshore wind energy as well as energy trading and distribution worldwide, Ørsted is currently investing more than EUR 2 billion annually and plans to expand its capacities to 6.7GW in Northern Europe within the next few years, Pinsent Masons said.
Stuff co.nz 17 March 2017Family First Comment: A superb commentary to (finally) bring some balance to the media coverage. “…the fact that abortion remains in the Crimes Act serves a symbolic purpose. It’s a reminder that abortion involves extinguishing a life, no matter how hard the pro-choice lobby tries to disguise that fact.”www.chooselife.org.nzOPINION: Is there any issue more polarising than abortion? It’s a sensitive subject because we know that tens of thousands of New Zealand women, in fact probably hundreds of thousands, have had abortions.They will have had them for a variety of reasons – some compelling, others perhaps less so. We know from Abortion Supervisory Committee reports that some women have had multiple abortions. Of those who had abortions in 2015, 43 had had seven or more, 74 had had six and 193 had had five, which suggests they regarded the procedure as no big deal and presumably no cause for regret. But a much greater number of women will have agonised over the decision, and a significant number will have suffered psychological consequences. Decades of feminist insistence that abortion is simply a matter of women’s rights and women’s health won’t necessarily have made them feel any better about getting rid of the human life taking shape inside them.…. This is an issue so polarising that even the labels applied to the opposing camps are contentious. Abortion rights lobbyists prefer to be called pro-choice rather than pro-abortion, which is understandable. “Pro-abortion” implies that they think sucking a foetus out of the womb and dumping it in a plastic-lined bin is a good thing, which surely can’t be the case. “Pro-choice” frames the issue much more inoffensively as an issue of women’s rights rather than babies’ deaths. Conversely, “anti-abortion” suggests a hard, unsympathetic line and may even conjure up images of the fanatics who firebomb abortion clinics. “Pro-life” puts a friendlier, more positive spin on the anti-abortion stance. We can expect to hear more from these groups after the Abortion Supervisory Committee, in its latest report, recommended a review of the 40-year-old legislation that sets out the circumstances in which abortions may legally be carried out. Like it or not, we’re back in the old minefield. Abortion rights activists took the report as the cue to mount a fresh campaign for liberalisation of the law, as the committee surely must have known they would. The activists were quick to pick up the committee’s statement that some of the language in the Contraception, Sterilisation and Abortion (CSA) Act is sexist and outdated, as if that somehow renders the entire legislation invalid.Outdated language can be easily fixed, but highlighting the issue is a clever propaganda tactic because it portrays the act as a quaint hangover from an era when men supposedly told women what to do. In truth, the renewed debate is about much more than semantics. Complaints about sexist language are a smokescreen, because merely making the act gender-neutral wouldn’t achieve the activists’ objective. When they talk about “reviewing” the legislation, what they really mean is rewriting it to make abortion available on request – their goal since the 1970s. The committee has obligingly opened the door a crack and the abortion rights lobby has jammed its foot into the gap, as the committee possibly intended. The abortion rights lobby wants abortion decriminalised – that is to say, no longer treated as an offence under the Crimes Act, which they regard as an anachronism. To all intents and purposes the provision relating to abortion in the Crimes Act is negated anyway by the CSA Act, which enables the Crimes Act to be legally sidestepped.Nonetheless, the fact that abortion remains in the Crimes Act serves a symbolic purpose. It’s a reminder that abortion involves extinguishing a life, no matter how hard the pro-choice lobby tries to disguise that fact.READ MORE: http://www.stuff.co.nz/national/politics/opinion/90496428/karl-du-fresne-the-minefield-that-is-abortion-lawKeep up with family issues in NZ. Receive our weekly emails direct to your Inbox.
Share Sharing is caring! 48 Views no discussions Share Norris Prevost; photo credit: Workers Voice OnlineDominican men are being called upon to turn out in large numbers to participate in this week’s Catholic Men’s Retreat which gets underway tonight at Fatima Church.Every evening this week, from 6:30pm,The Catholic Men of the Parishes of St Alphonsus, Cathedral, Fatima, St Luke’s and St Mark, will gather at the Fatima Church in Newtown for the Men’s Lenten retreat, in preparation for the Holy Feast of Easter.This year’s retreat will be preached by His Lordship Bishop Malzaire, Bishop of the Diocese of Roseau, as well as of St. Johns-Basterre.The Theme of this year’s Retreat is “Disciples on Mission, Gifted and Called to be Priest, Prophet, and King.” Each evening, His Lordship will share on a different aspect of the theme.Monday’s focus will be on the call to worship, Tuesday on the call to be Christian Family, Wednesday the call to Service, Thursday the call to reconciliation, and Friday the call to Evangelize.According to Cathedral Branch Dacamen President Norris Prevost, “We the catholic men of the Parishes of St Alphonsus, Cathedral, Fatima, St Luke and St mark, are exceedingly blessed to have his Lordship be the preacher for our men’s retreat which commences on Monday coming , 4th April, and runs every night starting at 630 pm, until Friday 8th,”.Bishop Malzaire as we know has responsibility for two Dioceses, Roseau, and St john’s-Basterre.Prevost said the fact that he has allocated the whole week, to help our men in Dominica prepare for Easter, is a demonstration of his caring and concern for our men and our families.“As President of the Cathedral Branch of the Association of Catholic men, I wish to call on our men from all the communities From Cockrane, Fond Cole, Pottersville, goodwill, Bath estate Laudat, Trafalgar, Morne Prosper, Watton Waven, Copt Hall , Louisville, Roseau ElmsHall, Kings Hill, Newtown, Fortune, Loubiere, Castle Comfort, Wall House, Giraudel, Egleston, Loubiere Bellevue Chopin, Point Michel, Soufriere, Gallion and Scots Head to come to our Catholic men’s retreat,” Prevost said.He sad as family men, “we must be serious with God, and answer his call to come and pray for the help we need for our families, our communities and our Country”.Dominica Vibes News
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Share HealthLifestyle Regular Pap Smear Boosts Cervical Cancer Survival: Study – Screening is important even after HPV vaccine, experts say by: – March 2, 2012 (HealthDay News) — Women who have regular Pap tests to screen for cervical cancer are more likely to survive if they are ever diagnosed with the disease, a new Swedish study suggests.Compared to women whose cervical cancer is detected because of symptoms, those diagnosed after a routine Pap smear increased their cure rate from 66 percent to more than 90 percent, the researchers said.“Regular Pap screening does not just prevent cancer by looking for precursors, but it also increases the possibilities of cure if the cancer is detected during screening,” said lead researcher Dr. Bengt Andrae, of the Centre for Research and Development at Uppsala University. “We can say the benefit of Pap smear screening is real.”In a Pap smear, cells scraped from the opening of the cervix are examined under a microscope. This year, more than 12,000 women in the United States will be diagnosed with cervical cancer, and more than 4,000 will die from it, according to the U.S. National Cancer Institute.For the study, published in the March 1 online edition of the BMJ, Andrae’s team collected data on more than 1,200 Swedish women diagnosed with cervical cancer from 1999 to 2001.The researchers found 92 percent of the women who were screened regularly were cured, compared with 66 percent of the women diagnosed once symptoms had developed.Cure rates were also higher among women screened according to established guidelines, compared to women who were overdue for a Pap test, they found. Of nearly 400 women who died from cervical cancer, 75 percent had not had a Pap test within the recommended time.Dr. Jennifer Wu, an obstetrician-gynecologist at Lenox Hill Hospital in New York City, said that “this is what we expected. Pap smears are good preventive measures for trying to catch cervical cancers early.”With cervical cancer, symptoms don’t appear until the cancer has spread to other parts of the body. At that point, the cancer is in an advanced stage, which is difficult to treat, she said.“In patients that go for yearly checkups, we usually catch these problems before they become cervical cancer,” she said. “Or, if there is cervical cancer it is in an early stage where the chances of survival are greatest.”Guidelines from the American Cancer Society recommend that screening for cervical cancer start three years after a woman becomes sexually active, but no later than age 21. Screening should be done every year or every two years after that.At age 30, if a woman has had three normal Pap tests in a row, she can be screened every three years. After age 70, if Pap tests have been normal for 10 years and three tests in a row, certain women may stop screening altogether, according to the guidelines.However, Wu said she thinks sexually active women with different partners should be screened every year, regardless of previous findings.The new vaccine to protect against the human papillomavirus (HPV) will protect women against about 70 percent of cervical cancers. But Andrae said even women who have been vaccinated need to continue Pap smears.“The vaccine doesn’t cover all HPV types. It covers the worst type, but there are still HPV types not covered, and you need to be screened for those,” he said. “And also, you may have been infected before you were vaccinated and the vaccine won’t do any good. That’s why you have to go on being screened.”Many people are afraid screening might find cancer, so avoid these tests that could save their life, Andrae said. “You shouldn’t fear what might be found in screening. Regular Pap smear screening is effective,” he said.Some screenings, such as the PSA (prostate-specific antigen) test for prostate cancer, are less efficient, because abnormal findings can result in unnecessary treatment, Andrae said. But the Pap screening “is as good as we thought,” he said.By Steven ReinbergHealth Day
Promoted Content2020 Tattoo Trends: Here’s What You’ll See This YearWhich Country Is The Most Romantic In The World?10 Risky Jobs Some Women Do5 Of The World’s Most Unique Theme ParksTop 6 Iconic Supercar MoviesEver Thought Of Sleeping Next To Celebs? This Guy Will Show YouCouples Who Celebrated Their Union In A Unique, Unforgettable Way10 Largest Cities In The World10 Outrageous Ideas That Made People Ridiculously RichBirds Enjoy Living In A Gallery Space Created For Them13 kids at weddings who just don’t give a hoot6 Interesting Ways To Make Money With A Drone Loading… The Copa America due to kick off in June in Argentina and Colombia was on Tuesday postponed by a year to 2021 because of the coronavirus pandemic, organisers CONMEBOL said. Brazil won the 2019 Copa America on home soil but the 2020 edition, now postponed to 2021, was due to be played in two countries for the first time The announcement came shortly after UEFA’s decision to also push back the 2020 European Championship by 12 months. Sport and football all over the world has come to a grinding halt due to the coronavirus outbreak with the Champions League, Copa Libertadores and almost all national football leagues suspended. Other sports like tennis, golf, rugby and Formula One have also either delayed or cancelled a host of events and competitions. According to the latest figures more than 180,000 people worldwide have been affected by the coronavirus outbreak with 7,400 people dying from the COVID-19 disease. The Copa is South America’s main continental competition between national sides and had been scheduled to run from June 12-July 12. “This has hit us hard, we were really excited about staging it,” Colombia’s Sports Minister Ernesto Lucena told AFP. But “health comes before competition.” It was due to be staged for the first time in two countries rather than one, with 12 teams taking part, including invitees Australia and 2022 World Cup hosts Qatar. “It’s an extraordinary measure due to an unexpected situation, and therefore responds to the fundamental need to avoid an exponential evolution of the virus,” said CONMEBOL. The tournament is now rescheduled to run from June 11-July 11 in 2021. – ‘Copa will return’ – “It wasn’t easy to take this decision but we have to safeguard at all times the health of our sportsmen and all the stakeholders that form part of the large South American football family. “There’s no doubt that the oldest national team tournament in the world will return with renewed strength in 2021, ready to once again make the continent and the whole world vibrate with the passion that also defines us.” The decision was taken in conjunction with UEFA’s move to postpone the Euros. “We also thank UEFA and its president Aleksander Ceferin for working together and the co-ordinated decision to also postpone the 2020 Euros for the betterment of the whole football family,” added CONMEBOL. The South American governing body had decided to align the Copa, which mostly used to be played in odd years, to the Euros in order to reduce the impact on European clubs, where a large number of South American international players ply their trade. Chile’s Colombian coach Reinaldo Rueda said the decision was “coherent” with the aim of aligning the Copa to the Euros. Club football all over the world has been suspended due to the coronavirus leaving teams and leagues sweating on whether they will be able to finish the current season. The start of World Cup qualifying in South America, which was due to begin at the end of March, has also been postponed. Many governments have imposed travel restrictions and even total lockdowns on their populations’ movements. The suspension of the Copa and Euros increases the chances of domestic leagues being brought to a conclusion, as long as such social limitations are lifted in the coming weeks or months. – Champions Brazil – Brazil won the last Copa in 2019 on home soil, beating plucky outsiders Peru 3-1 in the final at Rio de Janeiro’s iconic Maracana stadium. For the next edition, the 12 competing teams have been drawn into two geographical groups, one in the north of the continent, hosted by Colombia, and the other in the south, hosted by Argentina. Australia have been drawn in the south zone and Qatar will play in the north zone. Read Also: Mikel Obi quits Trabzonspor by mutual consent The final will be played in the Estadio Metropolitano in Barranquilla, Colombia. “Obviously there are economic impacts, but for now preparations are just delayed,” said Lucena. Colombia’s only previous success was in 2001, the last time they hosted the Copa. The 2024 Copa America will be held in Ecuador. FacebookTwitterWhatsAppEmail分享 
INDIANAPOLIS — The jobless rate in Indiana remained steady in July at 5.9 percent, according to a newly released report from the Indiana Department of Workforce Development.The state reports 9,990 private sector jobs added last month with gains concentrated in the manufacturing sector. Indiana leads the nation in manufacturing growth over the past year and ranks second in manufacturing jobs added since July 2009.Officials said the unemployment rate held steady despite private sector gains due to a sizeable increase in the labor force. The unemployment rate last year was 7.6 percent.“Indiana followed up a record-breaking June by adding nearly 10,000 more private sector jobs in July,” said Scott B. Sanders, Commissioner of the Indiana Department of Workforce Development.“The Hoosier labor force has also grown by over 54,000 individuals in the past year at a rate that is more than eight times larger than the national rate of growth during the same time period, which is quite remarkable.”