In direct contrast to earlier posting, Tamiflu caught again the public attention - this time for far from envious reason.
Two recent incidents - juvenile suicides without any underlying social cause, were widely published in Japan, including extensive coverage in two consecutive nights on February 26 and 27, 2007 by the national TV broadcaster NHK. Undoubtedly, the interviews with broken relatives of the young victims should increase the public awareness and hence to make parents closely monitoring the treated children. Yet, the science behind the frightening cases in Japan is not revealed.
The holder of the Manufacturing and Sale Approval for Tamiflu in Japan is Chugai Seiyaku of the Roche group. The product was approved in two formulations in 2002, sold since then to millions and stocked for tens of millions. The world supply of Tamiflu is not unlimited, as Japan also uses the majority of the world’s Tamiflu supply for seasonal flu. Japan has used 24 million prescriptions - ca. four times more than the US. World-wide, since Tamiflu was first approved in 1999, 12 children under 16 years of age and taking the drug have died, and 32 have suffered “neuropsychiatric events” such as hallucinations, confusion, convulsions and brain inflammation. All the deaths and the vast majority of adverse events in children, also including skin rashes and sensitivity, have been reported in Japan, where Tamiflu has been most widely prescribed. For the fiscal 2006 year, the MHLW received 12.8 billion Yen in supplementary budget as 8 billions of which to be spent for Tamiflu (90%) and Relenza (10%).
Back in 2005, both FDA and EMEA held discussions to analyze the frightening side events observed in Japanese children, but concluded that the “increased reports of neuropsychiatric events in Japanese children are most likely related to an increased awareness of influenza-associated encephalopathy”, increased use of Tamiflu in Japan, and greater monitoring of adverse events.
Certainly, the voices that the exacerbated reactions to Tamiflu among Japanese pediatric patients may be related to ethic (pharmacogenomics?) cause are being heard, but still the overprescription theory rules.
Jouhoublog is a joint blog - post or send comments to .