Objective:
The objective of this study was to identify problems in the approval,
pharmacovigilance, and post-approval regulatory decision-making
procedures involving gefitinib and to propose countermeasures
to prevent further drug-induced suffering in Japan in the future.
Methods: We comprehensively reviewed reports regarding gefitinib
published during the period from 2000 to 2006 by regulatory agencies,
the manufacturer of the gefitinib-containing drug, cancer clinical
study groups, and a scientific society.
Results: We identified the following major problems in the approval,
pharmacovigilance, and regulatory decision-making procedures:
1) the results of animal experiments and pre-marketing clinical
trials, and reports of adverse drug reactions from other countries
were not properly reflected in the label; 2) indications for the
drug were expanded without strict evaluation of the external validity
of pre-marketing clinical trials; and 3) despite many serious
cases of interstitial lung disease (ILD) being spontaneously reported,
well-designed post-marketing surveillance was not immediately
performed.
Conclusions: We propose a mandatory total registry of all drug
users and surveillance (i.e. a prospective outcome study) as one
of the rational solutions for preventing further drug-induced
suffering in Japan.
