Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database.
OBJECTIVE
To detect signals of adverse drug events after imipenem treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD).


METHODS
We performed data mining using KIDS-KD, which was constructed using spontaneously reported adverse event (AE) reports between December 1988 and June 2014. We detected signals calculated the proportional reporting ratio, reporting odds ratio, and information component of imipenem. We defined a signal as any AE that satisfied all three indices. The signals were compared with drug labels of nine countries.


RESULTS
There were 807582 spontaneous AEs reports in the KIDS-KD. Among those, the number of antibiotics related AEs was 192510; 3382 reports were associated with imipenem. The most common imipenem-associated AE was the drug eruption; 353 times. We calculated the signal by comparing with all other antibiotics and drugs; 58 and 53 signals satisfied the three methods. We compared the drug labelling information of nine countries, including the USA, the UK, Japan, Italy, Switzerland, Germany, France, Canada, and South Korea, and discovered that the following signals were currently not included in drug labels: hypokalemia, cardiac arrest, cardiac failure, Parkinson's syndrome, myocardial infarction, and prostate enlargement. Hypokalemia was an additional signal compared with all other antibiotics, and the other signals were not different compared with all other antibiotics and all other drugs.


CONCLUSIONS
We detected new signals that were not listed on the drug labels of nine countries. However, further pharmacoepidemiologic research is needed to evaluate the causality of these signals.
Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
Kyounghoon
K
Park
Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
Mick
M
Soukavong
Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
Jungmee
J
Kim
Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
Kyoung Eun
KE
Kwon
Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
Xue Mei
XM
Jin
Medical Research Collaborating Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Joongyub
J
Lee
Medical Research Collaborating Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Bo Ram
BR
Yang
Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea. bjpark@snu.ac.kr.
Byung Joo
BJ
Park
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use; D057225:Data Mining; D016208:Databases, Factual / Q000706:statistics & numerical data; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D015378:Imipenem / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D016017:Odds Ratio; D017891:Pharmacoepidemiology; D060735:Pharmacovigilance; D056910:Republic of Korea
D000900:Anti-Bacterial Agents; D015378:Imipenem
Imipenem; KIDS-KAERS database; pharmacoepidemiology; pharmacovigilance; signal