FDA Approves Neurotoxic Flu Drug For Infants Less Than One

FDA Approves Neurotoxic Flu Drug For Infants Less Than One

Whereas the flu is self-limiting, the FDA's capacity for bad decisions is not...

The recent decision by the FDA to approve the use of the antiviral drug Tamiflu for treating influenza in infants as young as two weeks old, belies an underlying trajectory within our regulatory agencies towards sheer insanity.

Tamiflu, known generically as oseltamivir, has already drawn international concern over its link with suicide deaths in children given the drug after its approval in 1999. In fact, in 2004, the Japanese pharmaceutical company Chugai added "abnormal behavior" as a possible side effect inside Tamiflu's package.  The FDA also acknowledged in its April, 2012 "Pediatric Postmarket Adverse Event Review" of Tamiflu that "abnormal behavior, delirium, including symptoms such as hallucinations, agitation, anxiety, altered level of consciousness, confusion, nightmares, delusions" are possible side effects.[i]

Recent animal research on Tamiflu has found that the infant brain absorbs the drug more readily than the adult brain,[ii]  [iii]lending a possible explanation for why neuropsychiatric side effects have been observed disproportionately in younger patients.

The very mechanism of Tamiflu's anti-influenza action may hold the key to its well-known neurotoxicity. Known as a neuromindase inhibitor, the drug inhibits the key enzyme within the flu virus that enables it to enter through the membrane of the host cell.  So fundamental is this enzyme that viruses are named after this antigenic characteristic. For instance,  the "N" in H1N1 flu virus is named for type 1 viral neuromindase.

Mammals, however, also have neurimindase enzymes, known as 'sialidase homologs,' with four variations identified within the human genome so far; NEU1,NEU2,NEU3 and NUE4.  These enzymes are important for neurological health. For example, the enzyme encoded by NEU3, is indispensable for the modulation of the ganglioside content of the lipid bilayer, which is found predominantly in the nervous system and constitutes 6% of all phospholipids in the brain. 

It is therefore likely that neurimindase-targeted drugs like Tamiflu are simply not selective enough to inhibit only the enzymes associated with influenza viral infectivity. They likely also cross-react with those off-target neurimindase enzymes associated with proper neurological function within the host. This "cross reactivity" with self-structures may also explain why the offspring of pregnant women given Tamiflu have significantly elevated risk of birth defects (10.6%) relative to background rates (2-3%), according to a 2009 safety review by the European Medicines Agency.

Beyond the recognition of Tamiflu's intrinsic toxicity, there are two additional problems with the use Tamiflu in infants:

  1. Infants do not yet have a sufficiently developed blood-brain barrier capable of keeping the chemical out of their rapidly developing brains
  2. Their detoxification systems are not sufficiently developed to remove the chemical rapidly enough to prevent harm

The FDA's decision to include infants under one as treatable with Tamiflu is all the more disturbing when you consider that a 2010 study published in The Pediatric Infectious Disease Journal found that of 157 evaluable infants (mean age 6.3 months) treated for influenza with Tamiflu, complications due to the medication were found in the majority (54%) of the treated group.

According to the study

Complications were recorded in 84 patients (54%), the most serious of which were meningitis in 1 infant (1%), pneumonia in 9 (6%), and otitis media in 2 (1%).

Are meningitis, pneumonia and otitis media (ear infection) acceptable risks for treating influenza? Apparently for the FDA, it is.

How about death? Is that an acceptable risk of Tamiflu treatment for flu, a self-limiting disease?

In 2011, the International Journal of Vaccine Risk and Safety in Medicine published an article titled, "Oseltamivir and early deterioration leading to death: a proportional mortality study for 2009A/H1N1 influenza," described 119 reports of Tamiflu-induced death. According to the study:  "of 119 deaths after Tamiflu was prescribed, 38 deteriorated within 12 hours (28 within 6 hours)."

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Blood Brain Barrier

If the jury is still out (and it might very well be)...you did not present it that way. It was presented as fact.

Blood Brain Barrier

Hello Sayer, I am writing to question your statement that the BBB is not fully developed in a newborn. Based on recent research, the statement does not appear to be correct. In 2010, researchers at Stanford University and UCSF proved that it is fully formed in utero. Read the following: http://www.livestrong.com/article/307566-infant-development-of-the-blood-brain-barrier/ I am not suggesting that Tamiflu should be given to infants, I am pointing out a possible error in your article that should be addressed. If I am correct I would ask you to post a correction or statement of errata. Thank you. Greg Evans, Pharm.D.

Blood Brain Barriers

Dear Greg,

  Thank you for sharing the Live Strong article. Unfortunately, however, the reference links within that article do not reveal a MEDLINE-cited study to confirm the article's main proposition.

  I believe, however, that they refer to the work of Saunders and his colleagues, who proposed that that intercellular tight junctions between cerebral endothelial cells in the BBB are well developed from early embryonic life. Saunders does, however, acknowledge the following:

  1. These junctions are present in blood vessels in fetal brain and are effective in restricting entry of proteins from blood into brain and cerebrospinal fluid. However, some features of the junctions appear to mature during brain development.
  2. There is a decline in permeability to low molecular weight lipid-insoluble compounds during brain development which appears to be due mainly to a decrease in the intrinsic permeability of the blood-brain and blood-cerebrospinal fluid interfaces.

It has also been observed that during the first 6 months of life cerebrospinal fluid contains higher concentrations of specific proteins relative to plasma, indicating higher permeability at that stage.  It is known that permeability to small lipid-insoluble molecules is greater in developing brain; more specific mechanisms, such as those involved in transfer of ions and amino acids, develop sequentially as the brain grows.

The point here would be that while it is possible that the blood-brain-barrier is fully developed when compared to the adult structures (meaning, the range of cells involved are fully differentiated and "committed" at that point), they may not yet have fully matured, and therefore do not behave in the same way. The adult brain, for instance, is likely much less permeable to tamiflu, which is what the animal studies show, indicating as much as a 70-fold increase in tamiflu within the youngest animals studied. In other words, the cells and their structure in the BBB may be fully developed in their structure, but not yet fully matured in their function.

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