FDA Approves Tamiflu for Newborns Despite No Safety Evidence

by Sarah TheHealthyHomeEconomist January 1, 2013

On December 21, 2012, the FDA expanded use of the anti-viral drug oseltamivir, known by the brand name Tamiflu, to children as young as two weeks old.

Crazy?

Absolutely.

Surprising?

Not in the slightest.

While shocking, this recent move is yet another demonstration of the FDA’s unrelenting spiral to complete and utter lunacy in its decision making.

How the FDA could approve a drug like Tamiflu for children so young when it is already under scrutiny in Japan for a possible link to suicide and other abnormal behavior in children is totally incomprehensible.

As recently as April 2012, the FDA even recognized that oseltamivir, the active ingredient in Tamiflu, was associated with ”abnormal behavior, delirium, including symptoms such as hallucinations, agitation, anxiety, altered level of consciousness, confusion, nightmares, delusions” as possible side effects of pediatric patients taking the drug.

The most compelling reason which calls into question the FDA’s approval of Tamiflu for infants is a 2010 study published in the The Pediatric Infectious Disease Journal which found that off label use of Tamiflu in babies resulted in 84 of the 157 infants (average age 6.3 months) experiencing complications from the medication the most serious being meningitis (1%), pneumonia (6%), and otitis media (1%). 

No Safety Studies on Tamiflu for Babies

There are certainly no controlled, randomized, placebo-controlled trials on the safety of Tamiflu for babies as testing on babies is obviously considered unethical – so what possible evidence could the FDA have used for this unfathomable decision?

Did the FDA just extrapolate data from previous studies on Tamiflu use in adults and older children to justify the decision?  Is this possible despite the fact that infants have not yet developed a blood-brain barrier that is able to keep a chemical out of the brain, which grows at its most rapid rate the first year of life? In addition, a baby’s detoxification mechanisms are also inadequately developed to remove a chemical out of the body quickly enough to prevent damage.

Neither of these biological facts were obviously considered in the decision.  Babies were simply assumed to handle the drug in a similar manner to adults or adolescents!

It is abundantly clear in the rendering of this decision that the FDA was only attempting to please Roche, the manufacturer of the active chemical ingredient in Tamiflu, whose shareholders are undoubtedly extremely concerned about the December 15, 2010 report from the World Health Organization (WHO) that viral resistance to Tamiflu is growing.

The FDA was not in any way attempting to protect the public or help save babies’ lives from the flu by expanding Tamiflu to infants.  Rather, it seems quite apparent that the move is an attempt to boost Roche’s short-term profits from the drug before expanding viral resistance renders Tamiflu ineffective and it becomes yet another Blockbuster drug relegated to the Big Pharma dustbin.

Didn’t know that your tax dollars are being used to pay the salaries of Federal bureaucrats who frequently operate as de facto corporate employees rendering decisions solely to benefit the bottom line of private companies?  Welcome to the Brave New World of Corporate Socialism.

 

Sarah, The Healthy Home Economist

Sources: Tamiflu Side Effect Concerns Grow After Japan Deaths

FDA Approves Neurotoxic Drug for Infants Less Than One

FDA Expands Tamiflu’s Use to Treat Children Younger Than 1 Year

Picture Credit

 

Comments (82)

  1. Our doctor prescribed Tamiflu for our two daughters just this morning. We chose not to fill the prescription. Our insurance PEIA will not even cover the full dose. They only cover the first 2 days of the dose and then we pay for the rest if we want it. My daughters are only 5 and 8 and we chose not to get Tamiflu. We NEVER get flu shots and have never had the flu until now. Our girls have been sick since Sunday and will be fine by Friday , when they are cleared to go back to school.

    Reply
    • Good decision, Melissa. I have a college age friend who was exposed to “swine flu” supposedly and when he began being symptomatic, they gave him Tamiflu. Well, wasn’t too long til he was on a ventilator fighting for his life. He went on the heart transplant list for a while and recently was taken off. They told him that it was from swine flu, but when I researched Tamiflu…oh my! Unbelievable side effects and he fit the profile. So, just always good to research anything that is put into the body and don’t trust any website with a conflict of interest. Just finished watching “Farmageddon” for the first time and I am outraged at what is being done in the name of “science!” God save America.

      Reply
  2. Eh, they can get away with putting pharmaceuticals on the market without safety studies, but supplements are criticized for having “no evidence of safety”.

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  3. Tamiflu has only shown to reduce the number of days with the flu by 1.3 days AND that’s only if you take it within the first 2 days of your symptoms. The flu or any viral/bacterial infection needs to just run it’s course. Think of it as a workout for your immune system. The more it comes in contact with the stronger it will be and be ready for even more environmental attacks. The more colds and such that kids get before the age of 6 will improve their immune systems exponentially and be able to defend itself later in life. Eating nutrient dense foods, supporting local food providers, growing and cooking your own food–all of these things lead to a healthier lifestyle. My 2 year old got the flu (we all did) and she was over it in 2 days (she was still breastfeeding), all of us were well over it within 5 days, whereas it took most of the rest of our family (who all eat junk) almost a month to feel normal again!

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  4. I have taken Tamiflu and can attest that it absolutely causes hallucinations. Just what you need when you’re already running a temp of 103!

    My husband literally had to sit at my bedside because I was convinced that there were people watching me sleep. Not a good experience and it still took me 10 days to get better!

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  5. My entire household had the flu several weeks ago: that included DH, our nephew staying with us (age 25) and both my boys (ages almost 3 and 8). They had to stay home for 2-3 days, run a fever, some chills, etc. Everyone was back to normal within a week. Even though I nursed all four guys for 3 days at home I did not get the flu. In fact, I’ve never had the flu, period! DH started saying something about getting the flu shot and I just said ‘you’ll be gambling on whether the strains in the shot will match what’s in the air, plus you will probably have flu-like symptoms for several days after the shot anyway, and you’ll be getting junk like aluminum and formaldehyde in the shot, too’. He gave up after that. None of us have ever had the shot and both my boys are vax-free. It was a bit inconvenient as I had to take 2 vacation days to stay home with the boys but they made it through virtually drug-free and without antibiotics, flu shots, Tamiflu, etc. I would do it again in a heartbeat! Too bad I did not have oscillococcinum on hand – I will definitely go get it next time!

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  6. Im sure both my boys ages 3 &1 have the flu right now all i do is keep them as comfortable as i can let them rest as much as they want. I have added chamomilla because my 1 yr old is teething at the same time. I couldnt bring myself to drug them with something that’s not even safe for a teen :(

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  7. Sarah Couture Pope via Facebook January 2, 2013 at 11:02 am

    If anyone is still under the mistaken notion that the FDA actually works to protect the public, this decision should be the straw that breaks the camel’s back! There is absolutely no reason whatsoever for this decision OTHER than attempting to boost profits from the drug for Roche who is probably concerned about evidence that there is viral resistance to the drug developing and the drug won’t be used for much longer …

    Reply
  8. Sarah Couture Pope via Facebook January 2, 2013 at 12:10 pm

    I have the utmost respect and admiration for MDs who buck the system and refuse to go along with the FDA and CDC insanity. They are really risking their careers and licenses by doing so. If you find one who thinks for himself/herself, they are KEEPER.

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  9. Disgusting. Truly, the FDA has ceased to provide anything of value to the world and needs to be dissolved for the betterment of society. Not only is Tamiflu associated with terrifying side effects and virus mutation, but even its own website boasts only a 30 hour reduction in flu symptoms. Compare that (surely exaggerated estimate) to the 3 to 4 DAY reduction in flu that elderberry extract has been clinically proven to accomplish–with no side effects, and for about 1/10th the price of a Tamiflu prescription! Natural solutions are far, far more effective and safe. Of course there is no multi billion dollar industry built around natural flu remedies so we don’t hear much about them.

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  10. Beyond comprehension. It’s hard to believe that humans are behind decisions like this. Yes, I know the FDA is a big, monstrous, essentially useless protector of corporate profit, but still…PEOPLE make these decisions. Can’t quite get my head around it. They have to sleep at night, right?

    Reply
  11. Sarah Couture Pope via Facebook January 2, 2013 at 2:10 pm

    Jill-David Boman I agree .. totally beyond comprehension. You have to wonder how in the *world* they get away with this. We HAVE to stay educated don’t we as most doctors are not up on what is truly going on.

    Reply
  12. Barbara Torrey Centofante via Facebook January 2, 2013 at 2:32 pm

    @Donna Jenkins… have you been tested for MTHFR ? With that severe reaction you could have methylation issues which make pharma something you better be very careful of. Do not ever take Cipro or any of the other flourine/flouride medications and anesthesias unless you want to open the door to a cascade of health problems like bursting/tearing tendons, weakness, etc. I have a MTHFR gene mutation… so this happened to me. To forewarned is to be forearmed .

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  13. Donna VanZandt via Facebook January 2, 2013 at 2:33 pm

    seizures can be a very permanent side effect in toddlers 1 yr or at any age. I remember when the govt prevented thalidomide (sp) in the US for morning sickness. Great Britain had a generation of babies born with no arms or legs. The US just had a couple who had gotten the drug from GB.

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  14. It’s hard to believe even an adult would take Tamiflu, especially after all those poor Chinese people started jumping off buildings. My dog received Tamiflu as a puppy for a Parvovirus infection. He now suffers from seizures.

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  15. Julie Benoit via Facebook January 2, 2013 at 7:31 pm

    It’s not even “safe” to apply sunscreen on babies before 6mos., And yet they approve tamiflu for a 2 week old. Completely nuts.

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  16. nuts! my friend 55 yrs old just went into rehab at a nursing home for 2 weeks. she refused flu shot becuase of all I have told her. but then let them give her what she said she was told what you take when you dont get flu shot. they made it sound like inasent drug! they gave her tamiflu. she then told them about what she was feeling. they told her it was not anything she was taking cuasing it. I read her the list of side effects to it. boy is she hoopin mad now. and I think she just got her wake up call and is ready to hear more about bad md scenice!!! just stay away from it all. tamiflu for babies…just anouther way to kill our kids!!!! sick bastards!

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  17. I just saw a commercial for it and it said its only for use in adults and children 1 year or older (not that that makes it any better) so I’m just wondering why there is a contradiction..?

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  18. A few years ago, my kids were exposed to H1N1. My son tested positive for type A flu (we opted to not test for H1N1). Pediatrician said to let it run it’s course. He would only consider Tamiflu for my daughter because she has asthma, but in general, he did not like giving Tamiflu to kids.
    Bekah\’s last post: Did I Cause This Nightmare?

    Reply
  19. I remember being shocked years ago when hearing about France’s own Phen-Phen disaster.
    There were pharmacists refusing to fill doctor’s prescriptions for it: some of their clients eventually needed DOUBLE TRANSPLANTS.

    At the end of this news report, the voiceover said, “And at this minute the FDA is approving this drug”.

    Reply
  20. The FDA cares only about making money for the big corporations. Giving such a powerful drug to babies is insane. Giving this drug to anyone seems like a very bad idea, given the comments above.

    Much better to build up your immune system with real food. As for babies, the milk of a healthy mother will protect them from all kinds of illness.

    Reply
    • What else is new? My daily “flu shots” include eating the best foods I can find and the rest of the components of my health program. Why bother with this toxic garbage when natural ways exist to prevent the flu, like tonic herbs, among countless others? As an example, astragalus will prevent the flu and improve the overall health of a person short term and long term.

      Reply
  21. IMHO that is not socialism it is a cor·poc·ra·cy (kôr-pkr-s)
    n. pl. cor·poc·ra·cies
    1. A society dominated politically and economically by large corporations.
    And I think it is a natural outcome of letting capitalism with a Capital C run amok. Money is more valuable to the society than the social good.

    Reply
  22. While I completely agree that this drug should NOT be given to infants or even young children, I don’t like the idea of using a study that shows complications of pneumonia, ear infections, and meningitis as substantiation. These symptoms are very likely something that would occur in infants who are either misdiagnosed in the first place, or would occur as a secondary infection, such as middle ear issues. A psychiatrist told me recently that studies have to show ALL symptoms or so-called side effects–i.e., anything that the subject feels is reported during the study. So if they took tylenol and got heartburn (most likely due to poor diet anyway), the study would show a percentage of side effects being heartburn. So, in conclusion, I don’t think studies are a good way to gauge good or bad science. Because we know that lots of studies are biased in that the drug companies are sponsoring them in the first place!

    Reply
  23. Research D-lenolate (eastpark) as an alternative to prescribed flu remedies and shots. All Natural viral and bacterial fighter. It is olive leaf extract and very effective.

    Reply
  24. we gave my son tamiflu when he was just over 2 years old and i still regret it. i didn’t take the time to research it as i was scared and he had the swine flu. he totally had the hallucinations and was clutzy and hurt himself while on it. i hope there are no long-term effects!

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  25. Umm, how do we know that these aren’t just complications from the flu and not a problem with the drug?

    “…oseltamivir, the active ingredient in Tamiflu, was associated with ” abnormal behavior, delirium, including symptoms such as hallucinations, agitation, anxiety, altered level of consciousness, confusion, nightmares, delusions” I have had high fevers (which is common with the flu) and suffered from several of those symptoms, and I have never had Tamiflu.

    “…off label use of Tamiflu in babies resulted in 84 of the 157 infants (average age 6.3 months) experiencing complications from the medication the most serious being meningitis (1%), pneumonia (6%), and otitis media (1%). ” Again, these are all common complications from the flu, whether or not you have taken Tamiflu.

    Just sayin’.

    Reply
  26. They recommended it for my 5 year old. Never have I been so greatfull that I couldn’t afford the $212 out of pocket expense.. The whole family got the flu and beat it in a week with rest and vitamins. My doctor made me feel guilty for not filling it. Screw you, was all I could think…

    Reply
  27. Kathleen Hassett via Facebook March 11, 2013 at 5:14 pm

    OMGosh!!!!!!!!!! Have you all read the side effects of this? I’d rather have the flu! I hate big pharm!

    Reply
  28. April Brown via Facebook March 11, 2013 at 6:45 pm

    In 2003, I contracted the flu while in the hospital with my 10mth old recovering from RSV. Her pediatrician gave me a Rx for Tamiflu. LLL didn’t know much about it. While I did get better, my baby would not nurse because all of a sudden she was sleepy. I stopped taking the Tamiflu and she wasn’t sleepy anymore, nursed and got better.

    Reply
  29. Cindy Swalboski Stauffer via Facebook March 11, 2013 at 10:20 pm

    I was scared and gave it to my son at 2.5 years old when he had swine flu. Big mistake. He must have been hallucinating, was uncoordinated and running into things and waking up with nightmares. I didn’t do my research in advance (we were rushed and scared) and later I found out it decreases the illness maybe one day! Sooo not worth it. Not to mention that I am sure that tamiflu use will just cause flu virus to mutate more and tamiflu will become even more ineffective…

    Reply
  30. Cindy Swalboski Stauffer via Facebook March 11, 2013 at 10:22 pm

    Oh and a side effect? More diarrhea… Wtf? How can they even call this a treatment for flu?!

    Reply
  31. Penelope Paisley via Facebook March 12, 2013 at 4:28 am

    How long until doctors start waking up and realizing they’re doing the dirty work for the biggest evil?

    Reply
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