Fears rise over side effects of Tamiflu as cases of adverse reactions double in a week

Fears rise over side effects of Tamiflu as cases of adverse reactions double in a week


By Daniel Martin
Last updated at 2:00 AM on 03rd August 2009



Fears over the side effects of Tamiflu grew last night as it was revealed that the number of suspected adverse reactions had doubled in one week.

Figures from the drugs safety watchdog, seen by the Daily Mail, show there have been 293 reports of side effects from the powerful antiviral since the beginning of April, when the swine flu outbreak began.

This compares to the 150 reported the week before - a jump of 143 in only seven days. The cases include heart and eye problems, and psychiatric disorders.


More than half of children who take Tamiflu suffer from nausea, nightmares and other reactions, a study found

The figures come only a few days after a study showed that more than half of children who take Tamiflu suffer from nausea, nightmares and other reactions.

The massive rise coincides with the launch of the National Pandemic Flu Service, which allows Britons for the first time to get Tamiflu over the phone or internet without the intervention of a GP.

In the first three days of its operation - between 24 and 26 July - no fewer than 150,000 Tamiflu packs were handed out.

A growing number of doctors have raised concerns over whether the drug is being handed out too readily, putting many at needless risk of side effects when in the majority of instances, swine flu is a mild illness.

The 293 cases, reported by doctors to the Medicines and Healthcare products Regulatory Agency, are only of suspected adverse reactions. However, those that turn out not to have been caused by Tamiflu are likely to be only a fraction of the total.

There were 465 separate reactions reported, referring to 293 individuals.

Around a third involved gastrointestinal problems, such as vomiting and diarrhoea.

But there were also cases of heart and eye problems - together with 46 cases of psychiatric disorders and 48 disorders of the nervous system. There has also been one unexplained death.

Last week England's top doctor urged parents to continue giving their children Tamiflu if they come down with swine flu.

Sir Liam Donaldson, the chief medical officer, appealed for calm after the release of a study which showed that 53 per cent of children who take it suffer from nausea, nightmares and other reactions.

Sir Liam said: '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.'

There are, however, fears that if Tamiflu and the other antiviral drug Relenza are given to too many, it could lead to the flu virus developing resistance to them - leaving-Britain defenceless against swine flu until the arrival of new vaccines.

A spokesman for the MHRA said: 'Tamiflu and Relenza are acceptably safe medicines and most people will not suffer any side effects. The balance of risks and benefits for Tamiflu and Relenza remains positive.'

Gap year students have been advised against charity work in Third World countries - because they could do more harm than good by spreading swine flu.

Professor Robert Dingwall, an adviser to the Department of Health, said young Britons had a 'personal ethical responsibility' to consider cancelling such work.




Study: Tamiflu causes nausea and nightmares in children

More than half of children taking antiviral drug Tamiflu suffer side-effects such as nausea, insomnia and nightmares, UK researchers have said.

Two studies from experts at the Health Protection Agency (HPA) showed a "high proportion" of British schoolchildren reporting problems after taking the anti-viral drug.

Data was collected from children at three schools in London and one in south west England who were given Tamiflu earlier this year after classmates became infected.

...

Almost one in five (18 percent) of the children 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," researchers said.

The UK's Department of Health said in a statement: "The European Union regulatory position remains that no causal association between Tamiflu (or Relenza) and an increase in neuropsychiatric events has been established."

Reports from Japan, where Tamiflu has in the past been widely-used against seasonal flu, has linked the drug in rare instances with unusual neurological and psychiatric disturbances in children, according to media reports.

Japan is now advising against prescribing Tamiflu to youngsters aged 10 to 19 after its own studies revealed people reporting psychiatric symptoms, according to media reports.



http://en.wikipedia.org/wiki/Oseltamivir

"....Adverse effects

Common adverse drug reactions (ADRs) associated with oseltamivir therapy (occurring in over 1% of clinical trial participants) include: nausea, vomiting, diarrhea, abdominal pain, and headache. Rare ADRs include: hepatitis and elevated liver enzymes, rash, allergic reactions including anaphylaxis, and Stevens-Johnson syndrome.<4><5>

Various other ADRs have been reported in postmarketing surveillance including: toxic epidermal necrolysis, cardiac arrhythmia, seizure, confusion, aggravation of diabetes, and haemorrhagic colitis.<4>


Neurological effects

There are concerns that oseltamivir may cause dangerous psychological, neuropsychiatric side effects including self harm in some users. These dangerous side effects occur more commonly in children than in adults.<12> This stems from cases in Japan, where the drug is most heavily prescribed, consuming 60% of the world's production<13>. Concern has focused on teenagers, but problems have also been reported in children and adults.

In March 2007, Japan's Health Ministry warned that oseltamivir should not be given to those aged 10 to 19. The Ministry had previously decided, in May 2004, to change the literature accompanying oseltamivir to include neurological and psychological disorders as possible adverse effects, including: impaired consciousness, abnormal behavior, and hallucinations.<13>

According to Japan's Health Ministry, between 2004 and March 2007, fifteen people aged 10 to 19 have been injured or killed by jumps or fallen from buildings after taking oseltamivir, and one 17-year-old died after he jumped in front of a truck.<14> A renewed investigation of the Japanese data was completed in April 2007. It found that 128 patients had been reported to behave abnormally after taking oseltamivir since 2001. Forty-three of them were under 10 years old, 57 patients were aged 10 to 19, and 28 patients were aged 20 or over. Eight people, including five teens and three adults, had died from these actions.<15><16><14>

In October 2006, Shumpei Yokota, a professor of pediatrics at Yokahama City University, released the results of research involving around 2,800 children which found no difference in the behavior between those who took oseltamivir and those who did not. Chugai Pharmaceutical Co. (which produces oseltamivir in Japan) gave Yokota's department 10 million yen (about US$105,000) over five years.<17>

To determine whether to lift the 2007 ban, a research team from the Japanese Health, Labour and Welfare Ministry studied 10,000 children under the age of 18 who had been diagnosed with influenza since 2006. The study was finalised in April 2009. Taking into account all degrees of abnormal behaviour, including minor behavioural problems such as incoherent speech, the study found that children who took oseltamivir were 54 per cent more likely to exhibit abnormal behaviour than those who did not take the drug. When the team limited its analysis to children who had displayed serious abnormal behaviour that led to injury or death, it found those who had taken oseltamivir were 25 per cent more likely to behave unusually.<18>

In November 2006, the United States Food and Drug Administration (FDA) amended the warning label to include the possible side effects of delirium, hallucinations, or other related behavior.<19> This went further than the FDA's previous pronouncement, from a year before, that there was insufficient evidence to claim a causal link between oseltamivir use and the deaths of 12 Japanese children (only two were from neurological problems, although more have died since then).<20> The change to a more cautionary stance was attributed to 103 new reports that the FDA received of delirium, hallucinations and other unusual psychiatric behavior, mostly involving Japanese patients, received between August 29, 2005 and July 6, 2006. This was an increase from the 126 similar cases logged between the drug's approval in 1999 and August 2005....."

Roche points out that oseltamivir has been used to treat 50 million people since 1999, and states that influenza may itself cause psychological problems

which seems to be the case, and without the GP getting involved, they ARE going to get more unnecessary side effects

As to the claim that influenza might cause psychiatric effects... of course, severely dehydrated people tend to have very ahem... interesting reactions. Hell I could tell stories form back country rescues.

Now here is the necessary disclaimer. ALL drugs you take, OTC or otherwise, have the potential to kill you, no matter how many times you have taken them without any effects before.

I wasn't sure how similar in effects Tamiflu is from star anise. Isn't it a synthetic made from it?

People who fear science will meet their end one way or another.

It's their right to die this way, so let them.