First Tamiflu (oseltamivir), now Relenza (zanamivir):
Health officials [in Canada] are investigating whether Relenza - a drug provinces have stockpiled in case of a pandemic flu outbreak - can be linked to fatal reactions or abnormal behaviour in children.[snip]
The investigation is a response to recently updated safety warnings issued by the U.S. Food and Drug Administration (FDA) or Relenza. In March, pharmaceutical giant GlaxoSmithKline updated Relenza's safety labels after children in Japan were reported to suffer from delirium, hallucinations. Some died after injuring themselves.
A similar warning was issued by the FDA for Tamiflu - the other drug provinces have on hand in case of a pandemic outbreak - in February. (Canwest News Service)
The use to treat symptomatic flu is not at issue as much as widespread use of either Relenza or Tamiflu in otherwise healthy people as a daily prophylactic against becoming infected or clinically ill during a pandemic. In that case millions of people would be taking these drugs and even rare adverse reactions would be almost sure to occur if the drug caused them.
But Relenza has to be inhaled directly into the lungs as it is not absorbed into the blood stream as is the more common antiviral, Tamiflu. As a result it is not used as often in children. It is also unclear whether and to what extent the drug could penetrate the nervous system and cause the reported effects. Moreoever mutations conferring resistance against Relenza have yet to appear, in distinction to Tamiflu, where such mutations are becoming more common. Still, the fact that these effects have been reported in Tamiflu raises the index of suspicion, so Health Canada's updating the safety label makes sense. I'm guessing the US FDA will follow suit in time. The decision was based on these data:
According to Health Canada's adverse reaction database, 27 people have reported adverse reactions to Relenza, including one adult who died. One 14-year-old reported nightmares and another six-year-old temporarily lost consciousness.
Another 96 people reported adverse reactions to Tamiflu, including 11 adults who died and nine who reported psychiatric problems.
There's not magic bullet for the pandemic preparedness problem. All the "simple" solutions -- stockpiling antivirals, stockpiling vaccines that don't exist, quarantines and school closures -- brings with them new problems of their own. The tougher solution -- rebuild the medical care, public health and social service systems to be ready for and hardened against a public health catastrophe -- is still the best one.
Unfortunately it seems to be too expensive for most people, even though it is really the cheapest. You get what you pay for.
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There is no free lunch. For many years I have been reading disturbing adverse events for oseltamivir coming out of Japan. For those folks who are purhasing these drugs off the Internet--if you actually got the real deal, do you know the risks you're running? Of course, if you get H5N1 perhaps the AEs won't matter.
Marissa.
Could the mechanism causing the side-effect have an additive-multiplier effect in combination with the direct viral encephalitis?
In that case, the AEs would matter.
Also...are we sure we really want to put healthcare workers on (supposed) preventative doses of antivirals for months on end...as the pandemic progresses?
I follow the H5N1 bird flu news almost everyday. I read all of the cases in Indonesia and what is happening in other countries and I know that Tamiflu is very effective in saving lives. The stockpiling of Tamiflu is a prudent measure and so is the same act of stockpiling Relenza which is almost as effective against H5N1. These are all we have so far that are effective as far as antivirals against H5N1 and the influenza virus. I am sure these reports are true that thye are having problems with adverse reactions in children and maybe they need to look at a lower dosage. The drugs were probably not designed with children as the target population. So a re-designed version is what is needed for them.
Other manufacturers can also get on the bandwagon here. If they have a better idea, bring it to market. We also keep hearing about design breakthroughs on vaccines, but where is the magic bullet? We are going to need something soon. Viruses are getting smarter and deadlier. We very well could be looking at a pandemic, who knows for sure? It would be prudent to ask your doctor for a prescription for Relenza and Tamiflu just to keep in the medicine cabinet at home. Also, do all of the other prep work that is suggested on all of the blog sites that have links to this subject. If a pandemic happens, I don't trust that the government is going to take care of all of us, that the hospitals are going to have medicine, enough repirators, and beds, that the grocery stores will have all of the food we want, or that even my neighbors will remain friendly once people start dying.
bigdudeisme: I am guessing you are right about the general effectiveness of the NI drugs, but it is only a guess. There is very little good data on this and I doubt either drug is "very effective" in treating H5N1. I'd settle for being a little effective. What is the evidence you are relying on here? Just curious, as I and others here also follow the news assiduously.
As to exactly how you would "redesign" a version for children, that's another question. This is not a matter of saying that if these drugs aren't perfect, let the market develop another one. The market doesn't care about people. It cares about money, not side effects in children and it works slowly, if at all for things like this. What if there is no real market? In any event, the question is what this means for flu preparedness now, and this raises some serious questions, most particularly, how the drugs should or could be used for prophylaxis in a pandemic.
Darn it, was going to get a prescription for Relenza next week from the doctor but after reading this I'm not sure at all.
When you say 'otherwise healthy people' revere I'd go so far as to say who is really healthy anymore? Our aging population is so entrenched in pharmaceuticals, our middle age still think they'll live forever, and the young, well they don't have the mental capacity to really realize the threat.
I've stocked alternative medicines and herbs, it seems they'll work as well if not better. If not, well then I'm dead, dead, dead.
Be careful with herbs, Lea. Many common OTC herbs(echinacea, St. John's Wart, kava, Silymarin milk thistle, blackroot, etc) are hepatatoxins, especially deadly if alcohol is consumed within three to four weeks of ingesting an herb. Effects also usually include increased bleeding from injury and in some rare cases death; for example, Hoang Nan is an organic, all-natural Asian herb confused with Strychnos nux vomica from which strychnine is obtained.
Your liver, you need to do some checking. Milk thistle is specifically used as an anti-hepatotoxin. http://carcin.oxfordjournals.org/cgi/content/abstract/15/6/1099
There are many common over the counter drugs as well as prescribed medicines that may result in liver injury. Intrinsic hepatotoxins, such as acetaminophen are seen far more often.
Under all circumstances anyone who chooses to use alternative medicines should do their homework or see a specialist. Experimenting is not a good idea.
I don't know what blackroot is. Kava kava has shown to be possibly hepatotoxic. Echinacea and liver damage is still unknown as it too has never been tested to my knowledge.
St Johns Wort has never been tested as an hepatotoxin. Virtually all reports of liver damage and the foregoing two herbs are anecdotal and limited to a very few. Not that they might not be responsible but, until formal controlled testing is done unproven.
Thanks for the concern and advice Your Liver. (wonder who you are though).
I'll take my chances with the alternatives, oscillococcinum for regular flu and then 30c of Gelsemium for the pandemic as it was used successfully during the Spanish flu.
And yes, I've done my homework.
The scientific literature is replete with mistakes concerning the safety and toxicity of medicinal plants and their extracts. I just ran across a 2006 paper that says that Echinacea contains berberine, which it does not, I assure you. Here is a pdf for an overview of some myths about Echinacea:
http://www.rrreading.com/files/Echinacea%20Myths.pdf
An excellent text on the subject is "The Essential Guide to Herbal Safety" by Simon Mills and Kerry Bone. Elsevier publishers.
Oh dear. Use of Gelsemium will be totally taken out of context. But I agree someone should take a good long look at that one and find the mechanism of action. My bet is on the strong relaxation effect because the other influenza remedies of the Eclectic physicians had the same properties.
Apologies ahead of time as I just got near boiling water spilled all over my hand. With that said ...
Not everyone is a doctor, physician, herbalist, homeopathic specialist, or naturopathic doctor, or into Biomimicry so please speak in easy to understand terms for crying out loud.
Are we here to help one another? sometimes I wonder.
DITTO!
Sorry. Hepatotoxin means liver toxin. I won't apologize about checking out the herbs prior to using. Some have side effects, others do not react well with drugs or other herbs, and some must be taken in moderation and or only for short duration. There are many misconceptions about the safety of phytochemicals(herbs)that are incorrect. Just because you can buy something without a prescription doesn't mean it is automatically safe for everyone to take. It is simply the wise thing to do prior to either spending your hard-earned money or taking something which isn't right for you.
Homeopathy is an area I know little about but, this is a great example of how information might be misinterpreted. Homeopathy uses trace amounts of an herb, I assume the same is true for Gelsemium. This is one of the herbs you do not want to injest!
http://www.drugs.com/npp/gelsemium.html
Toxicology
All parts of the plant contain toxic alkaloids that can cause paralysis and death, and should never be ingested. Gelsemium alkaloids are highly toxic. Ingestion of as little as 4 ml of a fluid extract has been reported to be fatal. Toxic symptoms include giddiness, weakness, ptosis, dilated pupils and respiratory depression. Gelsemicine is more toxic than gelsemine. 3
Toxicity has been reported in animals that have grazed on gelsemium, and bees that pollinate the plant have been poisoned. 2 Honey derived from the plant nectar has been reported to be toxic
injest should be ingest. It's late and I missed this one.
Dear Reveres,
As individuals we have no idea when or if we will get vaccine shots during the pandemic. Nor can we be confident that there will be enough Tamiflu, Relenza or anti-bacterial drugs to treat the flu and the accompanying bacterial pheumonia.
Having taken the view, that with this next pandemic, we are sailing into unchartered waters, and have stocked my Medicine Cabinet carefully. I have tried to cover all bases. I have both herbal and medicinal aids for the flu.
Reveres, what advice can you give about anti-bacterials? Can you name the very best anti-bacterial that is on the market? What is your opinion about the use of anti-bacterial's in conjunction with Tamiflu or Relenza?
Vic-Its not you BTW. Its the OZ server being used to shotgun porn, spam and viruses to the states. Use someone elses email and contact me. I can fix it.
Randy we are just about to go out on an installation. When we get back to the office, we will try to send you a message through our national carrier TELSTA. We basically only have one telecommunication system in Australia. Can't understand why America needs so many different and competing communication systems and companies. Will also try another persons email.
Randy,
I have no trouble emailing my good friend Lea in the States. If I recall correcctly we were emailing each other without problems. One day we would email each other and the next we could not. Did you put a bar on my email address by mistake? I know I can be frustrating - hey I am a techno cretin.
Has anyone seen any thoughts on why these drugs are having these types of side effects and why in the young in particularly? Thinking about their planned interactions (re viral release, clumping etc) what may be happening to get us to these unplanned side effects. If we can work this out it may be possible to nullify the unwanted effects with an off the shelf combination therapy candidate.
Tom, possibly, but we don't have enough mechanistic data to know. My point was that a few AEs in a situation where you have a high mortality rate really won't matter. Some of the side effects may be similar to SSRIs, which is failure by the liver to clear the drug due to enzyme deficiency, and a ise to toxic levels.
Vic-No, its the servers here protecting against security threats -server level stuff. Not you or me.
Hey... Does anyone know if Relenza gets into the water like Tamiflu? If its inhaled is the mechanism for clearing it different than Tamiflu?
Randy,
This is so strange. I get your weekly round-ups, but we can't email each other. Was telling Sandra (crofs H5N1), and she very kindly said we could try to send an email through her computer (she's American). Russell, has got quotation this morning, I will ask him to have a look at everything when he gets back.
Good question re- Relenza.
Shannon: my comments were directed more at phytosleuth than you honey.
In an effort to clear up any misunderstanding, so others reading here do not take it the wrong way or end up killing themselves!: oscillococcinum, a product of France, specifically Boiron, markets homeopathy products. I had thought, perhaps erroneously, that by mentioning oscillococcinum, that there would be an understanding afterwords that the mention of 30c of Gelsemium would be interpreted as the Boiron product.
Hello! I'm not going to eat the plant, gelsemium!!
Lea, it wasn't you I was cautioning. It was others reading the post and misinterpreting what was actually meant. As there are people here who take things at face value, I didn't want anyone to accidentally misconstrue a cure.