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
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..?
Nut jobs !!!
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!
Agreed!
Refused a tamiflu rx for my 10yo with confirmed type A. He was feeling better with home care in just a day or two
It’s not even “safe” to apply sunscreen on babies before 6mos., And yet they approve tamiflu for a 2 week old. Completely nuts.
Makes me want to vomit.
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.
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.
@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 .
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.