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[e-drug] Differences in Drug Datasheets (8)

E-DRUG: Differences in Drug Datasheets (8)
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We have studied the variability of alert status in labeling
(contraindication, caution, non-alerted) for major CYP3A4 mediated drug-drug 
interactions (DDIs) in Japan, US, and UK (Ohno Y, Hisaka A, Suzuki H, et al). 
There were quite a few discrepancies (data not published yet).

I agree that ADR labeling should be harmonized between the patented product
and the generics in one country/region (by the regulating body and/or
industry). However, in comparison to pharmacokinetic changes in DDIs, the
clinical relevance of ADRs are generally more population-dependent.
Therefore, before adopting an international standard in ADR labeling, I feel 
the need for a more scientific discussion on decision-making in ethnic
differences; i.e., not only the causes but also the consequences of the
labeling in each country.

Makiko KUSAMA
Graduate School of Pharmaceutical Sciences 
The University of Tokyo
JAPAN
kusamaki-tky@umin.ac.jp


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