Does Tamiflu have side effects?
A six year old girl has tragically died of swine flu. It seems that she was not suffering from any other illness and was not immunocompromised. From the information currently available from the media, she developed mild viral symtoms, thought to be tonsillitis, and sadly died a day or so later. She had not been given Tamiflu.
This is the dilemma facing all GPs, casualty officers, staff at NHS Direct and indeed anyone working on the front line in medicine. How do you distinguish between a mild viral illness and swine flu? The answer is simple. You cannot. A routine blood test will not help you. Swabs can be sent off for viral cultures but it will be several days before you get the answer. So, who gets the Tamiflu? The only logical course of action is to give it to everyone with any viral symtoms, however mild.
GPs and others on the front line are getting a deluge of perfectly reasonable phone calls from perfectly reasonable people who are suffering from what are probably mild, self-limiting viral illnesses but who are frightened. There is not a hope of saying with certainty who does or does not have swine flu. Sounds like this poor young girl who died was one of these people.
There is a touching and worrying public reliance on Tamiflu which the government, having nothing else to suggest, is promoting. Hard data (such as there is) on the efficacy of Tamiflu is not encouraging. It may shorten the duration of the illness by one day. No one really knows what effect it might have in terms of reducing swine flu mortality. And there is another iceberg approaching. I have never prescribed Tamiflu. No doctor in my practice has ever prescribed it. It is rarely used in the UK. Who knows what safety profile it has for mass useage? If, as is possible, several million people take it over the next few months, there may be problems with morbidity and even mortality due to the drug. Problems that, at the moment, are unpredictable. If Tamiflu offered a certain cure for swine flu, then the risks might be worthwhile. Sadly, that is not the case. At best it is of limited value. Let us hope that it does not turn out to have serious, hitherto undiscovered, side effects.
Labels: drug side effects, swine flu, Tamiflu
20 Comments:
I'm puzzled. Given the FDA, NICE and the like, how on earth do we end up with a drug of unknown efficacy and unknown propensity for side effects?
"I'm puzzled. Given the FDA, NICE and the like, how on earth do we end up with a drug of unknown efficacy and unknown propensity for side effects?"
NuZanuLiebor!
I have never prescribed tamiflu - if given within the first 48 hours it may shorten duration of symptoms by 1 day. The Daily mail however feel it is a wonder drug and todays front page accusses a GP of both misdiagnosis and failure to give tamiflu - http://gpinformed.blogspot.com/2009/07/swine-flu-fever.html
So as GPs what are we to do?
It is sad as well as scary, that we now have a case of someone who died of swine flu who didn't have any underlying condition. Would you still say that swine flu is still less dangerous than "regular flu"- but only sounds more dangerous due to media hype?
Donald Rumsfeld must be rubbing his hands with glee- and thanking the Daily Mail from the bottom of his wallet.
Neelu
As I have commented on your Swine Flu post a couple of days ago, my daughter was diagnosed with Swine Flu this afternoon, and without actually seeing a doctor. You chaps are so clever these days to have perfected remote diagnostics.
Daughter was prescribed Tamiflu and I went to a specific pharmacy where the script had been faxed over to join a worryingly large group of relatives and friends of similarly diagnosed people collecting Tamiflu for their loved ones. Is there more of this about than the media is letting on?
I have done the usual, and read all I can find, and realise that she is most likely to come through this - she is young and strong (29 years old) but she is still me daughter and it's not easy to lay aside natural concerns.
I appreciate your posts, and others comments, for at least laying the cards on the table for us non medical people here
Steve
We have people here in I.C.U's who were previously, healthy specimens of society.
Regarding Tamiflu, you wouldn't get me taking it, because it has been so publicly rammed down our throats, and whoopdedo one day off from Flu symptoms, for forking out between $70 and $90. When Ibuprofen would probably do the trick.
Side effects? You will probably find in 5 years, mens sperm count is lowered and everyone is rushing to buy a new 'wonder drug' produced by same companies to increase said production.
Darzi quits
Dr Crippen said ........ "Let us hope that it (tamiflu) does not turn out to have serious, hitherto undiscoverd, side effects".
This from Japan - "Tokyo’s Ministry of Health and Welfare today instructed the Japanese distributor of the drug to include a warning not to give the drug to patients aged between 10 and 19, after reports that at least 18 Japanese children taking Tamiflu have died as a result of irrational behaviour".
http://www.timesonline.co.uk/tol/news/world/asia/article1549260.ece
According to the MHRA summary of product characteristics (SPC) both anaphylaxis and bizarre psychiatric type syndromes have been reported after tamiflu.
http://www.mhra.gov.uk/Safetyinformation/Swinefluinformation/Antiviralmedicines/index.htm
Would tamiflu have saved the GP and the child, possibly?
Will a % of patients suffer serious and even fatal adverse drug reactions after taking it, almost certainly.
A review of the US Prescribing information would be informative:
(http://www.rocheusa.com/products/tamiflu/pi.pdf)
In general the US PI is much more helpful than the UK SPC to prescribers.
And don't forget to fill in the Yellow Forms when you encounter side effects. In the BNF Tamiflu has the stigmata (stigmatum?) of the black inverted triangle, meaning all side effects possibly attributable to treatment with Tamiflu should be reported. You can report side effects on line here: http://yellowcard.mhra.gov.uk/
Finally, the days when reporting side effects via the yellow card scheme were restricted to Doctors and pharmacists are long gone. Everyone, health care "professional" or member of the public can now do it.
Crippen has raised a really important point. To address it requires information. That information can only be collected and analysed if the Yellow Cards are filled in when folk get Tamiflu side effects.
Of course, if you prescribe Tamiflu for someone without seeing them and they then get Lyell's syndrome, you ought to ring your Defence organisation before filling in a yellow card.....
I read something recently that said 30,000 US citizens die every year of normal run of the mill flu. If this figure is correct then the swine flu is mild by comparison. I haven't seen figures for the UK so can't comment on them.
As to Tamiflu, no thanks, I'd rather go the Vit C, garlic, onion and spicy food route. At least no one will want to come near me and catch it off me.
At a local school, where there was an "Outbreak" a couple of weeks ago, 50% of children given their anti viral (not sure if it was Tamiflu or Relenza) stopped taking it before they had finished the course.....mainly due to vomiting. One child evcen required to be admitted via A&E with severe vomitting after starting Tamiflu.
The school children who stopped treatment however were 50% of the half who started - Half who were given it didnot even start! Not sure if these were well informed or if this just represents the underlying rate of non compliance or "pig ignorance".
It might be interesting if the 3 groups of school children (non starters, Stoppers and completers) were to be followed up in 5 years to see if there will be any significant unintended consequences of treatment.
UK figures are approx 1200-1500 people die each year from seasonal flu, (usually the elderly). Problem now is that the elderly are not getting swine flu, thought to be some protective element from bad flu in '58, so sadly it's young people and children that are being affected and some will die.
Generally it is a mild infection and those with underlying conditions are most at risk, though a few normally healthy people will sadly die.
The vaccine is apparently on it's way, no date yet and no plans as yet who is going to carry out vaccination of 60 million britons?!
And of course now there is a fear of a second wave which nobody knows what it does, and whether Tamiflu has any use at all. Maybe Vitamic C should be prescried with any Tamiflu (opps.. NHS can't afford that extra few pence..)
Swine flu is really dangerous. But what is this tamiflu.
http://www.resveratroluses.com
http://www.hilarysweightloss.com
question from naive non-health-care professional.
What proportion of patients previously presented (before we heard of swine flu)with "mild viral illness" turned out to have serious illness?
Ie Is swine flu the only virus that might look harmless to begin with but turns out worse than it looks to begin with?
Thanks for any answers.
"What percentage presenting with mild viral illness turn out to be more serioous?"
Difficult to put an exact figure on this but from experience certainly less than 1%. I think the language is important here. Genuine flu (whether swine variety or not) makes you feel absolutely aweful - temperature/headaches/hacking cough and widespread aches and pains. In fact a good guide is if you can get out of bed to walk to the kitchen for a drink you do not have flu. The CMO and all online symptom checkers talk about "mild symptoms" and seeking advice if symptoms are severe. Now anyone with genuine flu will feel that they have been hit by a bus and will probably never have felt so ill. To them, quite rightly,symptoms are not at all mild and so panic ensues "I must have a really severe/virulent form". Perhaps the CMO in one of his many many media interviews should mention just how ill flu makes you feel?
GP informed,
Thanks for the response. This serves as a good calibration. I had previously thought that flu was as you have descibed.
Recent language had made me wonder whether flu included "mild symptoms". Clearly, in your view this is not the case.
Now, Are we saying that swine flu has a greater propensity to present with "mild symptoms" that then get much worse, or that in this respect it is just like other flu's.
If the latter, for what its worth, I support your recommendation to the CMO.
Thanks
mereEngineer
Quandary , Quacktitioner with young son, 27, cardiomyopathy, arrythmia , open heart surgery 2 years ago, persistent huge globular heart with atria the size of a pair of grapefruit , diuretics, warfarinised.. Hmm, I think I'll be his Tamiflu buddy despite the risks. What would the average Tamiflu sceptic do?
The reason that the FDA don't fully know the risks is that you need a very large trial to detect a small difference, which is what you expect with mortality. It is much easier to run a smaller trial simply to detect something like time to relief of symptoms which everyone will have eventually, and this is the type of trial that almost always is run for regulatory purposes. Unfortunately once a drug is freely available it is almost impossible to involve people in a clinical trial, so we never get evidence.
I've written a brief article on Tamiflu here:
http://www.blacktriangle.org/blog/?p=1994
And a review here:
http://www.pjonline.com/cpd/adverse_drug_reactions_neuraminidase_inhibitors_widespread_use_for_influenza_may_reveal_more_adv
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