FDA Approves Tamiflu for Newborns Despite No Safety Evidence

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

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