FDA Approves Tamiflu for Newborns Despite No Safety Evidence

by Sarah TheHealthyHomeEconomist Activism, Healthy Living, Healthy Pregnancy, Baby & ChildComments: 82

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.




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

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Comments (82)

  • Kathy

    Helloooooo it’s called breastfeeding you nimconpoops!! (that’s German for idiot)

    January 1st, 2013 12:58 pm Reply
  • Melissa G.

    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.

    January 1st, 2013 1:21 pm Reply
    • watchmom3

      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.

      January 2nd, 2013 12:09 pm Reply
  • Kelli

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

    January 1st, 2013 2:00 pm Reply
  • Jennifer

    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!

    January 1st, 2013 2:04 pm Reply
  • Laurie

    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!

    January 1st, 2013 3:25 pm Reply
  • Magda

    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!

    January 1st, 2013 9:46 pm Reply
  • Jessica Hanks via Facebook

    I mean, I know the flu sucks and all, but seriously?

    January 2nd, 2013 10:50 am Reply
  • Amy Renee Guenst via Facebook


    January 2nd, 2013 10:50 am Reply
  • Sarah Reddick via Facebook

    Unbelievable. :( Those poor babies that will receive this. Billy Reddick

    January 2nd, 2013 10:52 am Reply
  • Loretta Mae Forman via Facebook

    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 :(

    January 2nd, 2013 10:53 am Reply
  • Elizabeth Pedigo via Facebook

    Wow. :( :(

    January 2nd, 2013 10:53 am Reply
  • Kele’n Len via Facebook

    Kele: What?! That’s terrible!!

    January 2nd, 2013 10:53 am Reply
  • Dana Green via Facebook

    so, essentially, the world is “ending”……in a way?

    January 2nd, 2013 11:02 am Reply
  • Konrad Mayer via Facebook

    How long before people start fighting back in numbers?

    January 2nd, 2013 11:02 am Reply
  • Sarah Couture Pope via Facebook

    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 …

    January 2nd, 2013 11:02 am Reply
  • Kiya Tabb via Facebook

    SO SCARY!! Why would anyone trust a drug company (or the FDA… or is that the same thing?) with their newborn?!

    January 2nd, 2013 11:07 am Reply
  • Sam Belina via Facebook

    Yikes. I have a sick infant right now. Thanks for the info!

    January 2nd, 2013 11:13 am Reply
  • Casey Shoemake via Facebook

    I had the flu two weeks ago. The community clinic recommended my babies (3 & 1) get preventative doses. Thankfully my pedi won’t use the stuff!

    January 2nd, 2013 11:26 am Reply
  • Tikva Sasson via Facebook


    January 2nd, 2013 11:32 am Reply
  • Andrea McDaniel Rhyne via Facebook


    January 2nd, 2013 11:37 am Reply
  • Farah Gainey Vann via Facebook

    I have lost so much trust in these services since becoming a mom

    January 2nd, 2013 11:38 am Reply
  • Donna Jenkins via Facebook

    This stuff made me a paranoid crazy person for three days when I took it as an adult. I couldn’t leave the house -and even the cat scared me!! NO WAY would I give it to my helpless children who could not reason away the symptoms.

    January 2nd, 2013 11:41 am Reply
  • Carol Reeves Mcdowell via Facebook

    I think our MD”S could be our allies if they weren’t so indoctrinated in the status quo. Then big pharma would really be in trouble. I think it is on us to educate them if they are willing to listen.

    January 2nd, 2013 11:53 am Reply
  • Renae Mcareavey via Facebook


    January 2nd, 2013 12:09 pm Reply
  • Sarah Couture Pope via Facebook

    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.

    January 2nd, 2013 12:10 pm Reply
  • Jill

    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.

    January 2nd, 2013 12:53 pm Reply
  • Carla Powell Henderson via Facebook


    January 2nd, 2013 1:03 pm Reply
  • Monica Reads via Facebook


    January 2nd, 2013 1:09 pm Reply
  • Jill-David Boman via Facebook

    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?

    January 2nd, 2013 1:48 pm Reply
  • Rick Hubbard via Facebook

    Its all about greed and illegal payoffs as kids did you remember all the disclaimers and warnings on meds? That’s when people actually cared about each other and the gov. did their jobs

    January 2nd, 2013 2:01 pm Reply
  • Sarah Couture Pope via Facebook

    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.

    January 2nd, 2013 2:10 pm Reply
  • Barbara Torrey Centofante via Facebook

    @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 .

    January 2nd, 2013 2:32 pm Reply
  • Donna VanZandt via Facebook

    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.

    January 2nd, 2013 2:33 pm Reply
  • Angela Hardy via Facebook

    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.

    January 2nd, 2013 2:54 pm Reply
  • Wendy Sellers-Brown via Facebook

    Makes me want to vomit.

    January 2nd, 2013 5:20 pm Reply
  • Jessica Felix via Facebook

    Refused a tamiflu rx for my 10yo with confirmed type A. He was feeling better with home care in just a day or two

    January 2nd, 2013 6:47 pm Reply
  • Julie Benoit via Facebook

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

    January 2nd, 2013 7:31 pm Reply
  • Megan

    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!

    January 2nd, 2013 7:52 pm Reply
    • Joyce


      January 2nd, 2013 9:18 pm Reply
  • Nour Alrayyashi via Facebook

    Nut jobs !!!

    January 2nd, 2013 7:55 pm Reply
  • Danielle

    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..?

    January 2nd, 2013 10:19 pm Reply
  • Bekah

    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.

    January 2nd, 2013 10:34 pm Reply
  • Elise Anna Chavez via Facebook


    January 2nd, 2013 10:56 pm Reply
  • Veronica Santacruz via Facebook

    oh dear!

    January 2nd, 2013 11:01 pm Reply
  • Barbara Torrey Centofante via Facebook


    January 2nd, 2013 11:10 pm Reply
  • Helen T

    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”.

    January 3rd, 2013 1:08 am Reply
  • Stanley Fishman

    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.

    January 3rd, 2013 2:17 pm Reply
    • High Brix Nutrient Dense Foods

      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.

      January 4th, 2013 5:28 am Reply
  • Shirley J

    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.

    January 4th, 2013 12:37 am Reply
  • cindy L.

    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!

    January 5th, 2013 9:43 pm Reply
  • Elizabeth

    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.

    January 12th, 2013 9:54 pm Reply
  • cindy

    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!

    January 15th, 2013 5:21 pm Reply
  • Marcia Jones via Facebook

    Absolute insanity! Fire them for sure!

    March 11th, 2013 3:49 pm Reply
  • Erin Tidwell Tovar via Facebook


    March 11th, 2013 3:49 pm Reply
  • Tamara Lynn via Facebook

    SMH so lame! They never get things right :/

    March 11th, 2013 3:50 pm Reply
  • Susan Bender Binzel via Facebook

    They recommended it for my 8 year old…

    March 11th, 2013 3:55 pm Reply
  • Stephanie Yurgen via Facebook


    March 11th, 2013 3:55 pm Reply
  • Phoenix Frost Ulfhamr via Facebook

    Man….. praying for all the families who don’t know better :(

    March 11th, 2013 3:57 pm Reply
  • Vanessa Kendall via Facebook


    March 11th, 2013 3:58 pm Reply
  • Melissa Schlosser Haas via Facebook

    Not surprised

    March 11th, 2013 3:58 pm Reply
  • Sarah Nunez via Facebook

    Totally typical for Big Pharma and their FDA shills.

    March 11th, 2013 4:02 pm Reply
  • Nakia Nieves-Talavera via Facebook

    Hopefully parents are Smart enough to do their own extensive research and not just give whatever to the poor kids who happen to be the victims of their ignorant decisions. Smh

    March 11th, 2013 4:06 pm Reply
  • Anna Kenfield via Facebook

    Do people listen to the FDA anymore?

    March 11th, 2013 4:08 pm Reply
  • thehealthyhomeeconomist via Facebook

    Anna Kenfield most conventional doctors do!

    March 11th, 2013 4:09 pm Reply
  • Shawnicy Barnhart via Facebook

    If the FDA says it is safe don’t eat or use it.

    March 11th, 2013 4:16 pm Reply
  • Anna Kenfield via Facebook

    Yes I’m aware. Does anyone listen or trust our conventional for-profit doctors anymore?

    March 11th, 2013 4:44 pm Reply
  • Donna

    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’.

    March 11th, 2013 4:59 pm Reply
  • Amy Renner Whalen via Facebook


    March 11th, 2013 5:00 pm Reply
  • Sarah Owens via Facebook

    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…

    March 11th, 2013 5:11 pm Reply
  • Kathleen Hassett via Facebook

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

    March 11th, 2013 5:14 pm Reply
  • Jana Makela via Facebook

    I took it pregnant :( and gave it to my little ones :( we were so sick and so scared and the midwife insisted.

    March 11th, 2013 5:39 pm Reply
  • Health-e-links via Facebook


    March 11th, 2013 6:09 pm Reply
  • Marilu Martinez-Vargas via Facebook

    Sadly, too many are taught to never question the doctor.

    March 11th, 2013 6:20 pm Reply
  • Tamera Hicks via Facebook

    Nothing EVER surprises me any more!!!

    March 11th, 2013 6:32 pm Reply
  • April Brown via Facebook

    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.

    March 11th, 2013 6:45 pm Reply
  • Gabriella Iacobone via Facebook

    Jana-the MIDWIFE insisted?! It really is a scary world when you can’t even trust a midwife, or often ND’s (they usually recommend a lowfat, vegetarian and soy-filled diet, ugh.) It’s up to us to take care of ourselves, sadly.

    March 11th, 2013 7:44 pm Reply
  • Cindy Swalboski Stauffer via Facebook

    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…

    March 11th, 2013 10:20 pm Reply
  • Cindy Swalboski Stauffer via Facebook

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

    March 11th, 2013 10:22 pm Reply
  • Penelope Paisley via Facebook

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

    March 12th, 2013 4:28 am Reply
  • Pingback: 06/19/13: 1st page of Google search results for the search term “FDA approves drug despite evidence” @ 7:56 p.m. (Copyright notice as for other pages like this one.). Copyright, with noted exceptions, L. Kochman, June 19, 2013 @ 7:57 p.m. | no

  • Wow really

    Okay, soooo…. I hate to break it you all you conspiracy buffs but NO medicines currently in the market now are actually TESTED on infants under 12 months. None… Like really. So if your whole basis for shock is the fact that this drug hasn’t been tested on babies for its effectiveness ( really?) then start throwing out every and any medicine you may have in your closet now….it wasn’t tested either.

    There are other ways to determine efficacy of a drug…and aside from the hallucinations ( very concerning) the other side effects mentioned are actual symptoms/ complications of the flu itself…so…. Yeah, if those alarm you so should getting the flu in the first place.

    Yeah, just thought I’d sprinkle some sense into the fear min getting being spewed on here….but don’t mind me,

    On with the freaking out!!!

    December 21st, 2014 2:13 am Reply

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