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Purpose: This study aimed to characterize elderly-specific revisions of prescribing information of a drug based on recent cases observed in postmarketing use in Japan. Methods: We analyzed all revisions of package inserts that were officially registered between the fiscal year (FY) 1998 and FY 2012. They were examined in terms of a description of the drug, therapeutic area for which the drug is targeted, the period between launch and revision, contents of the revisions, and the evidence sources of safety issues. Results: Of a total of 3,440 revisions occurring between FY 1998 and FY 2012, 2.1% were specific to drug use in the elderly. Drugs treating the “cardiovascular system” and a miscellaneous category of “various,” showed a higher frequency of revisions for elderly patients than those for non-elderly patients. Of elderly-specific revisions occurring between FY 2004 and 2012, the majority were triggered by spontaneous reports or regulatory action in other countries, although there were relatively a few examples of serious safety concerns being raised after initial drug approval. Conclusions: It is important that alternative approaches such as pharmacometrics or pharmacoeoidemiology should be more utilized in Japan for the early and better detection and evaluation of drug safety in elderly patients, especially for therapeutic areas that demonstrate increased susceptibility for risk among the elderly, such as drugs related to the cardiovascular system.

ELDERLY-SPECIFIC REVISIONS OF DRUG PRESCRIBING INFORMATION IN THE POSTMARKETING ENVIRONMENT IN JAPAN