Tamiflu warning in Japan after child suicides and injuries

[Al-khiyal]

· Doctors told not to give drug to teenagers

· Concern over favoured treatment for bird flu

Concerns about the anti-flu drug Tamiflu deepened today after doctors in Japan were warned against prescribing it to teenagers because of several cases in which young patients committed suicide or harmed themselves.

Japan's health ministry decided to act after a boy and a girl, both 14, fell to their deaths in suspected suicides last month and two 12-year-old boys suffered minor injuries after falling from buildings.

The move is likely to fuel anxieties about Tamiflu, which is being stockpiled around the world as the best available drug to combat a bird flu epidemic. The US Food and Drug Administration studied the evidence on deaths linked to the drug last November. Despite concluding that the drug should continue to be used, the US and Canada have asked its manufacturer, the Swiss pharmaceutical company Roche, to warn in its labelling that Tamiflu may cause abnormal behaviour.

The possible side effects came to light in 2005, when 12 children died and 32 exhibited abnormal behaviour, including running on to the road and falling from buildings. Since it was approved in Japan in 2001, 54 people have died while taking Tamiflu, which is imported to Japan by Chugai Pharmaceutical.

"As well as changing the warning distributed with the drug, we have directed Chugai Pharmaceutical to raise awareness among medical professionals of the risk of abnormal behaviour after taking Tamiflu," the ministry said. "While no causal relationships have been established, we judged it was necessary to warn doctors."

But Rokuro Hama, a doctor who drew attention 18 months ago to deaths among those who take Tamiflu in Japan, said he was disappointed that the ministry's action was limited to a warning over teenagers.

"More deaths are reported in infants and adults," he said. "There have been 38 cases of sudden deaths, of which 23 were adults and 15 were under 10 years old."

They died, he said, of respiratory suppression, suggesting the drug may have a similar effect to a sedative, alcohol or an anaesthetic. When the US authorities looked at the evidence in November, they said the possibility that Tamiflu was the cause of the sudden deaths could not be ruled out.

Roche insisted the drug was safe. It said there was no established causal link between Tamiflu and neuropsychiatric symptoms. Clinical studies in the US had shown that children being given the drug as a treatment for flu were less likely to exhibit such symptoms as delirium, delusion and self-harm than those not receiving treatment. A study by Japanese health authorities had also found no increase in psychiatric symptoms among patients taking Tamiflu.

"Influenza-associated delirium and neuropsychiatric disorders are not uncommon and occur in the United States in approximately four of every 100,000 influenza patients, resulting in hospitalisation," Roche said.

The company said that more than 45 million sufferers worldwide had taken Tamiflu, and the rate of psychiatric symptoms was one in 37,000 patients. Incidents that led to deaths occurred in only one in 5 million patients.

Japan has proved a lucrative market for Tamiflu. During the 2004-05 flu season, 6 million of an estimated 16 million Japanese sufferers took the drug. Doctors have been told not to prescribe it for patients aged 10-20, apart from those considered at high risk of developing serious flu-related symptoms.

People caring for young patients taking Tamiflu will be told not to leave them unattended for at least the first two days of their treatment.

Chugai said it accepted the guidelines and would raise public awareness of potential problems.

Tamiflu warning in Japan after child suicides and injuries

[Bent_Bladi]

la3ama! if a drug that's supposed to save your life kills you or makes you crazy enough to kill yourself, then to HELL with it...!!

[Al-khiyal]

Half of children taking Tamiflu have side-effects

July 31, 2009 -- More than half the children in England taking the swine flu drug Tamiflu suffer side-effects such as nausea, insomnia and nightmares, researchers have found. Two studies from the Health Protection Agency (HPA) show a high proportion of schoolchildren reporting problems after taking the antiviral drug. Data was gathered from children at three schools in London and one in the south-west of England who were given Tamiflu to try and stop them developing swine flu after classmates became infected. The researchers behind the study said while children may have attributed symptoms to the use of Tamiflu that were actually due to other illnesses, "this is unlikely to account for all the symptoms experienced".

Their research, published in the medical journal Eurosurveillance, looked at side-effects reported by 11 and 12-year-old pupils in a secondary school that was closed for 10 days after a pupil was confirmed to have swine flu after a holiday in Cancun, Mexico. Of the 248 pupils involved in the study, 51% reported side-effects, including nearly a third (31.2%) who felt sick, nearly a quarter (24.3%) who suffered headaches and more than a fifth (21.1%) who had stomach ache.

The researchers said "likely side-effects were common" and the "burden of side-effects needs to be considered" when deciding whether to give Tamiflu to children as a preventative measure. The researchers concluded that a "high proportion of school children may experience side-effects of oseltamivir (Tamiflu) medication". Another study, also published by Eurosurveillance, found that more than half of 85 children in three London schools had side-effects when given the drug as a preventative measure after a classmate was diagnosed.

Of the 45 children who suffered side-effects, 40% reported gastrointestinal problems including nausea, vomiting, diarrhoea, stomach pain and cramps, while 18% reported a "neuropsychiatric side-effect" such as poor concentration, inability to think clearly, problems sleeping, feeling dazed or confused, bad dreams or nightmares and "behaving strangely". The research was carried out in April and May – before the government decided to stop using Tamiflu preventatively. Only those with suspected or confirmed swine flu now get the drug. Clinical trials have shown that around 10% of people taking Tamiflu report nausea without vomiting, and an extra 10% experience vomiting, according to the researchers.

The government's chief medical officer, Sir Liam Donaldson, said Tamiflu should still be given to children if they had established symptoms and there were no existing medical reasons not to prescribe the drug. He told BBC Radio 4's Today programme: "All drugs do have side-effects. It is always a case of deciding the balance between benefiting a patient from a treatment and the side-effects. Most of the side-effects are relatively minor – a degree of nausea, a bit of a tummy upset, the sort of thing you get quite often with antibiotics. If we look at the rate of admissions to hospital, it has been the under-fives who have had a very much higher rate of hospitalisation. It isn't common but when it does happen, it can happen amongst the youngest age groups."

A spokesman from the Medicines and Healthcare Products Regulatory Agency (MHRA) said it was monitoring reported side-effects by GPs and the public. Between 1 April and 23 July the MHRA received a total of 150 reports of 241 suspected side-effects for Tamiflu and five reports for another antiviral, Relenza. A Department of Health spokeswoman said: "As is the case with many medicines, nausea is a known side-effect of Tamiflu, in a small number of cases. Symptoms may lessen over the course of the treatment, and it may help to take Tamiflu either with or immediately after food, and drinking some water may also lessen any feeling of nausea."

A statement from Roche, which manufactures Tamiflu, said the contribution of Tamiflu to neuropsychiatric events "has not been established". But three years ago the pharmaceutical company wrote to U.S. doctors warning that "people with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behaviour". The move followed a 10-month review by the U.S. Food and Drug Administration, which found 103 cases of "neuropsychiatric adverse events", including the deaths of a 17-year-old boy who was killed after jumping in front of a truck and a 14-year-old boy who fell after climbing on a balcony railing. More than two-thirds of the 103 cases occurred in children, and most were in Japan, then the biggest consumer of Tamiflu. The government says about 150,000 people in England have received Tamiflu via the National Pandemic Flu Service, which was launched last week.

[Al-khiyal]

Don't give Tamiflu to under-12s, warn researchers

August 10, 2009 -- Antiviral drugs like Tamiflu and Relenza that form the cornerstone of the government's fight against swine flu should not be given to children under the age of 12, researchers said today. They called on the Department to Health to immediately reassess its pandemic flu policy after finding that side-effects from medicines such as Tamiflu could outweigh any benefit.

The research, by Dr Matthew Thompson, a clinical scientist and Oxford GP, and Dr Carl Heneghan, from the John Radcliffe hospital in Oxford, found that in some children Tamiflu caused vomiting, which can lead to dehydration and complications. The team said it was "inappropriate" for Tamiflu and Relenza to be given to most children with mild flu symptoms. "The downside of the harms outweigh the one-day reduction in symptomatic benefits," Heneghan said.

"One of the health messages going forward should be that we do not rely on Tamiflu or Relenza based on the evidence we have today. GPs should be seeing more children to check their symptoms. Getting rid of the reliance on Tamiflu as a magic bullet is the way forward." The government has repeatedly referred to its stockpile of antivirals as one reason why people should not be overly concerned about the current pandemic.

The study, a peer review of seven trials, found Tamiflu had little or no effect on asthma flare-ups, ear infections or the likelihood of a child needing antibiotics. The research comes little over a week after other research found that children given Tamiflu reported side-effects including nausea and nightmares.

[Felicity]

so maybe foetuses should not take tamiflu either?

[Al-khiyal]

Don't give Tamiflu to under-12s, warn researchers

Don't give swine flu drugs to under-12s, says study

August 10, 2009 -- Children under the age of 12 should not be given Tamiflu or Relenza, the two antiviral drugs that form the cornerstone of the government's fight against swine flu, because their side-effects outweigh any benefits, Oxford University researchers said yesterday. A study by Dr Matthew Thompson, a clinical scientist, and Dr Carl Heneghan, a clinical lecturer, found that antivirals were no "magic bullet" and only led to a minor reduction in the length of time that a child with mild sickness was ill or the chance of their spreading the disease.

The research, to be published in the British Medical Journal, said that Tamiflu caused vomiting in 5% of children, which could lead to dehydration and complications. The Oxford researchers, both GPs, said children with mild symptoms should be treated in the same way as if they had any other mild flu – with drinks to cool high temperatures and rest – and there was no need for children who were otherwise healthy to be taking Tamiflu or Relenza. They called on the government to be clear about the limitations of the two drugs. "It would be quite reasonable for the Department of Health to make clear to parents and GPs how much help the drugs are," Thompson told a press conference.

The research, a peer review of seven trials, all but one previously published, looked at the effectiveness of antivirals in reducing seasonal flu complications and stopping the spread of the disease. They said their findings were relevant to the current swine flu outbreak because the diseases shared many characteristics. They found the drugs had little or no effect on asthma flare-ups, ear infections or the likelihood of a youngster needing antibiotics. The researchers also found that preventive antiviral use had little effect, reducing transmission of flu by 8%. Thirteen children would have to be treated to prevent one additional case of the flu, they said. The benefit of antivirals was that they reduced symptoms.

Heneghan said the current policy of giving Tamiflu for mild illness was an "inappropriate strategy". "The downside of the harms outweighs the one-day reduction in symptomatic benefits," Heneghan said. His advice to GPs was "not to rely on Tamiflu as a treatment to reduce complications" or to think of it as a "magic bullet". He likened the current policy, which saw more than 315,000 courses of antivirals given out during the first two weeks the national pandemic flu line was in operation, to misguided historical health policies such as the prescription of antibiotics for sore throats. "The problem is a resistance issue," said Heneghan. "Going forward we have a treatment which is ineffective because we've given it to everybody. We are calling for a more rational prescription process for these drugs."

One of the country's most respected flu experts, Professor Hugh Pennington, agreed that reliance on antivirals was increasing the possibility that the flu would become resistant sooner or later. "We cannot be certain that the virus will not get nastier. We might require antivirals for the elderly or others who are more likely to get complications. It means the potential that a resistant strain will get that selective advantage as it will grow in a Tamiflu environment." Norman Lamb, the Liberal Democrat health spokesman, said: "The government antiviral policy and flu line need to be kept under constant review. The cost involved is very high. Perhaps it should come down and be relaunched in the autumn. These are judgments for the chief medical officer."

The Department of Health disputed the relevance of a seasonal flu study to the current outbreak. "The extent to which the findings can be applied to the current pandemic is questionable – after all, we already know that swine flu behaves differently to seasonal flu, and past pandemics have hit younger people hardest. Whilst there is doubt about how swine flu affects children, we believe a safety-first approach of offering antivirals to everyone remains a sensible and responsible way forward. However, we will keep this policy under review as we learn more about the virus and its effects."

Roche, which makes Tamiflu, said: "Health authorities worldwide such as the National Institute for Health and Clinical Excellence (Nice), European Medicines Agency (EMEA) and the U.S. Food and Drug Administration (FDA) have reviewed the data from controlled clinical trials and approved Tamiflu (oseltamivir) for use in children based upon a positive benefit/risk assessment. There are significant data showing the medicine to be effective and well tolerated when used for the treatment or prevention of influenza in children."

[Al-khiyal]

so maybe foetuses should not take tamiflu either?

According to UK government health advice:

....Pregnant women should take Relenza, which is inhaled and helps reduce flu symptoms without affecting the baby. However, if a pregnant woman has unusually severe flu, a doctor may prescribe Tamiflu. An expert group reviewed the risk of anti-viral treatment in pregnancy and told the Government the risk was extremely small - smaller than the risk posed by the symptoms of swine flu...