In response, the government stockpiled
oseltamivir at a cost of over GBP600m (EUR680m; USD770m) from 2006 to 2014.
The FDA acknowledged in its approval that it does not know if
oseltamivir phosphate is effective in patients who start treatment after 2 days of developing symptoms, or have weakened immune systems.
3,4) This data makes the clinician alert to the problem and prompt to prescribe
oseltamivir when facing a flu syndrome.
Oseltamivir (Tamiflu[R], Roche-Korea), purchased from a pharmacy in Korea as prescribed by a medical doctor was used as positive control.
A 2014 systematic review included 8 RCTs in adults (3954 patients) and one RCT in children (669 patients) with influenza and compared time to alleviation of symptoms with
oseltamivir and placebo.
Keywords: Critically ill child, influenza,
oseltamivir, pediatric intensive care
Oseltamivir came on the market in many countries in 2000 after clinical studies had been conducted among influenza virus-infected patients with uncomplicated illness.
With respect to safety, there have been seven publications in the literature addressing the risk for major birth defects following treatment or prophylaxis with one or both of these products, with the majority of the published data relating to
oseltamivir exposure.
USFDA had given tentative approval to Natco Pharma for the generic
oseltamivir phosphate capsules on 14th March 2014.
The patients were randomly assigned to take Echinaforce Hotdrink syrup, a beverage containing an alcoholic extract prepared from freshly harvested echinacea (Echinacea purpurea) herb and root (95% herb; 5% root) supplemented with European elderberry (Sambucus nigra), for 10 days, or
oseltamivir for five days followed by placebo for five days.
However, the data highlight the difficulty in identifying all children who may benefit from
oseltamivir therapy, especially given that the majority of children with ILI don't have influenza,
oseltamivir therapy is best initiated within 48 hours of onset of symptoms, the most readily available test (rapid influenza testing) generally lacks sensitivity to identify those with influenza, and PCR testing is expensive and not available in many hospital emergency rooms.
Food and Drug Administration (FDA) approved
oseltamivir phosphate (Tamiflu[R]) for treatment in children as young as two weeks old (FDA, 2012).
