1.The Current Status of Health Food- or Supplement-Related Adverse Health Effects
Mayu Koike ; Fumiko Ohtsu ; Jinsaku Sakakibara ; Nobuyuki Goto
Japanese Journal of Drug Informatics 2013;14(4):134-143
Objective: Recently, use of health foods and supplements, as well as the amount of information available about them, has been steadily increasing. Therefore, a noticeable increase in adverse drug reactions caused by health foods and supplements has also been seen. The purpose of this study was to clarify the current status and backgrounds of patients with health food- or supplement-related adverse health effects.
Methods: We selected the cases of health food- or supplement-related adverse health effects from the Case Reports of Adverse Drug Reactions and Poisoning Information System (CARPIS) database, which contains over 57,000 case reports of adverse drug reactions. We investigated the background, suspected products and adverse events in each case and conducted univariate logistic regression analysis to determine significance.
Results: We obtained a total of 327 cases consisting of 103 causative products. Women comprised 66% of study subjects and had a significant association with dietary supplements. Patients with a history of liver disease had a significant association with liver damage caused by “Ukon,” a drink made from turmeric root and sold as an anti-hangover remedy in Japan.
Conclusion: The causative products had several unique features. This information should be utilized to prevent health food- and supplement-related adverse health effects in the future.
2.Risk Factors and Subjective Symptoms of Drug-Induced Thrombocytopenia
Masayuki Kakeya ; Fumiko Ohtsu ; Reiko Yano ; Jinsaku Sakakibara ; Nobuyuki Goto
Japanese Journal of Drug Informatics 2014;16(2):70-80
Objective: The present study investigated risk factors and subjective symptoms associated with drug-induced thrombocytopenia.
Methods: We selected 361 patients with drug-induced thrombocytopenia from the Case Reports of Adverse Drug Reactions and Poisoning Information System (CARPIS) database of over 65,000 case reports of adverse drug reactions and assigned these patients to a case group. We also randomly selected 794 cases of adverse drug reactions not associated with thrombocytopenia as a control group.
Results: Data were compared between the case and control groups, and results were analyzed using logistic regression analysis. We identified type of infection (non-viral) and renal failure as risk factors for drug-induced thrombocytopenia. In addition, administration of carbamazepine, methotrexate, interferon alpha, ticlopidine or valproic acid significantly increased the risk of drug-induced thrombocytopenia. Significant associations were also found between drug-induced thrombocytopenia and purpura, fever, and mucosal bleeding.
Conclusion: These findings provide helpful information for early detection and prevention of thrombocytopenia as a serious adverse drug reaction.