The following information is re-produced from the pharmalive website, without permission, for informational purposes.

Comments in brown come from the editor.

As an ordinary lay person, I have come to mis-trust the FDA. These are, after all, the folks who gave us "aspartame" and "vioxx" (according to FDA in-house researchers, Vioxx was responsible for over 40,000 patient deaths, a number  insufficient to mandate removing it from the market.)

You must draw your own conclusions about FDA motivations, veracity, and trustworthy-ness.

Pharmalive...(link)

The above link is presented for your easy and direct access to the source material.

What is Tamiflu and what is it approved for?

Tamiflu (oseltamivir phosphate) is an antiviral drug approved for treatment of uncomplicated influenza A and B in patients 1 year of age or older. It is also approved for prophylaxis (prevention) of influenza in people 13 years or older after household contact or at high risk for exposure during influenza season. Tamiflu is one of a group of anti-influenza drugs called neuraminidase inhibitors that act by blocking the viral enzyme neuraminidase which helps the influenza virus invade cells in the respiratory tract.
 

Is Tamiflu approved for use in pediatric patients?

Tamiflu is available in both capsule and liquid formulations. It is approved for treatment of influenza in children over 1 year of age. In the U.S., Tamiflu is dosed according to body weight in younger children. Older children (over 40 kg or 88 lbs) and adolescents receive the same dose as adults. It is also approved for prophylaxis (prevention) of influenza in children over 13 years of age.
 

What is useful about Tamiflu in pediatric patients? Who should use it? (Why Bother?)

When used as directed (twice daily for 5 days) Tamiflu can reduce the duration of influenza symptoms in otherwise healthy children by 1 to 1 ½ days. It also appears to reduce the severity of common flu symptoms. Consequently, it may allow children to return to school or other normal activities sooner. Tamiflu was also shown to be similarly effective in children who had a history of asthma and did not worsen the asthma symptoms.

Tamiflu is most effective when taken within 48 hours after the beginning of flu symptoms and not likely to be effective if patients have already had flu symptoms for several days. Patients (and their parents) should be aware that some patients with influenza may be at risk for secondary bacterial infections and should seek medical care if they are not improving within a few days of beginning Tamiflu.

Tamiflu has not been studied in children with very severe or complicated influenza who require hospitalization and it is not known whether it will provide the same benefit to children with severe illness.

What are the important safety issues and adverse events?

When Tamiflu was studied in clinical trials as treatment for children with influenza, children taking Tamiflu experienced similar side effects as children not taking Tamiflu. Serious side effects were not identified.  (what, nobody noticed?) The most common side effects observed in both the treatment and prophylaxis trials were nausea and vomiting. In these trials, a small number of children stopped taking their Tamiflu because of nausea and vomiting or other adverse reactions. (how would you feel if this were your child?) ... (Can a child give "informed consent"?)

In the safety review mandated by the BPCA, a number of adverse event reports were identified associated with the use of Tamiflu in children 16 years of age or younger. These adverse event reports were primarily related to unusual neurologic or psychiatric events such as delirium, hallucinations, confusion, abnormal behavior, convulsions, and encephalitis.  (gee, just what I want my grand kids to experience!) These events were reported almost entirely in children from Japan who received Tamiflu according to Japanese treatment guidelines (very similar but not identical to U.S. treatment guidelines). The review identified a total of 12 deaths in pediatric patients since Tamiflu's approval. All of the pediatric deaths were reported in Japanese children. In many of these cases, a relationship to Tamiflu was difficult to assess because of the use of other medications, presence of other medical conditions, and/or lack of adequate detail in the reports. (If we don't look at it, maybe it will "go away")

The review also identified severe skin reactions (like allergic reactions) in some pediatric patients. These events were not all reported in Japanese children and have also been reported in adults. Severe skin reactions in all age groups are currently being reviewed in more detail.
 

Denver Post, Nov 19, 2005

OTHER TAMIFLU CONSIDERATIONS

10:49 18 October 2006, NewScientist.com news service "Debora MacKenzie"

In a flu pandemic, millions of people are expected to take the antiviral drug Tamiflu, but new research shows that ultimately much of the drug will pass through the people taking it and end up in waterways. Chances are it will then linger long enough to promote Tamiflu-resistant flu viruses in wild birds.

As a vaccine tailored to the particular pandemic flu strain is unlikely to be widely available in the early days of an outbreak, emergency plans specify that sick people and, in some cases, people who have been exposed to the virus should be treated with Tamiflu. ~

~Previous studies have shown that Tamiflu is unusually resistant to being broken down in the body – about 80% of it is excreted in its active form. The drug also dissolves readily in water, and is not broken down in sewage sludge or by common chemical reactions in nature.

Andrew Singer and colleagues at the Centre for Ecology and Hydrology in Oxford, UK, estimated how much of this could potentially be flushed into lakes and rivers.

“We recommend more research to study how Tamiflu behaves in water, and to determine cheap and easy ways to break it down before it reaches the river,” says Singer, who led the research. The team suggests that perhaps some chemical that destroys Tamiflu might be put down the toilet by people taking the drug.

Journal reference: Environmental Health Perspectives (DOI: 10.1289/ehp.9574)

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