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
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 🙁
Unbelievable. 🙁 Those poor babies that will receive this. Billy Reddick
disgusting
I mean, I know the flu sucks and all, but seriously?
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!
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!
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!
Eh, they can get away with putting pharmaceuticals on the market without safety studies, but supplements are criticized for having “no evidence of safety”.
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.
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.
Helloooooo it’s called breastfeeding you nimconpoops!! (that’s German for idiot)