Premium
Post marketing surveillance of 13 products: safety and effectiveness
Author(s) -
Yoshioka Kazuko,
Kosasayama Akira,
Yoshida Mika,
Toshikura Miki,
Nasu Kunihisa,
Funabashi Shoichi,
Yamada Akimoto,
Okada Seizaburo
Publication year - 1999
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/(sici)1099-1557(199901/02)8:1<31::aid-pds392>3.0.co;2-m
Subject(s) - medicine , postmarketing surveillance , christian ministry , incidence (geometry) , drug reaction , pharmacovigilance , pharmacoepidemiology , food and drug administration , drug , package insert , jaundice , adverse drug reaction , family medicine , medical emergency , environmental health , adverse effect , pediatrics , emergency medicine , pharmacology , surgery , medical prescription , philosophy , physics , theology , optics
We surveyed the safety and effectiveness of 13 drug products under the reexamination system in Japan. Until the time of reexamination, a total of 106,328 case reporting forms were collected in the drug use investigations, while 1340 adverse drug reactions (ADRs) were reported in the spontaneous case reporting on ADRs. In the drug use investigations, the data were primarily obtained on the incidence of unexpected ADRs and the incidence of ADRs in special patient populations. The spontaneously reported ADR provided the data on serious and unexpected ADRs. We established proper use of the 13 products by examining the data for significant risk factors for serious ADRs, including agranulocytosis, jaundice, hypotension, and QT prolongation. We revised the package inserts of the 13 products with the new safety information a total of 50 times and passed on the revisions to health care professionals. We also assessed the safety and effectiveness of the 13 products compared with that before marketing. We summarized the data and submitted them to the Japanese Ministry of Health and Welfare (JMHW). For all 13 products, the same indications and dosage and administration as those approved previously were approved at the reexamination. Copyright © 1999 John Wiley & Sons, Ltd.