Tamiflu, the antiviral drug facing international criticism for its deadly side effects, has been approved by the US Food and Drug Administration for use on infants just two weeks old.
The FDA’s decision comes amidst international controversy over Tamiflu, known generically as oseltamivir. Since the drug’s approval in 1999, several suicide deaths and incidents of bizarre side effects have been recorded. In the UK, where use of Tamiflu was relatively low at the time of publication of a 2005 article, only 41 “yellow card” reports of adverse reactions were recorded, just one being agitation and two being “confusional states.”
In Japan, however, close to the cries of a then-imminent avian flu pandemic, 54 people with no previous discernible psychiatric or health complications were dead after taking Tamiflu in 2005.
Tamiflu-maker, Roche Holding AG, responded chillingly. “These events are extremely rare in relation to the number of patients treated.”
Haruhiko Nokiba, whose a 17-year old victim who committed suicide in 2004 after taking Tamiflu, says, “Had they issued a warning earlier, then the number of deaths could have been halved.”
FDA Following the Money
A warning label about such bizarre psychiatric side effects—like the one the Japanese pharmaceutical company Chugai slapped onto Tamiflu in 2004—might have affected Roche’s sales, which is where the FDA’s priority seems to be. This is, of course, conjecture—like the kind the FDA used when approving Tamiflu for use on infants under a year old.
Because of the unlikelihood that any parents would subject an infant to controlled, randomized, placebo-controlled trials of a drug associated with psychiatric distress, the FDA made their approval decision based on conjecture from studies involving older children and adults.
Existing Data Encourages Caution
What this conjecture fails to take into consideration, however, is an infant’s significantly greater vulnerability to drugs. Their lesser developed blood-brain barriers and detoxification mechanisms make them less capable as adults of keeping chemicals out of their developing brains and bodies.
As a neuraminidase inhibitor, Tamiflu blocks the principle enzyme in a flu virus that allows it to enter through the membrane of the host cell. Because mammals have four variations (that we know of so far) of neuraminidase enzymes, known as sialidase homologs, a drug like Tamiflu that targets these neuraminidases is likely very imprecise. These enzymes are crucial for neurological health, so “cross reactivity” associated with Tamiflu may be to blame for many things, like an increased risk of birth defects in offspring of pregnant women given Tamiflu.