Abstract
BackgroundRapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender) has not been proposed.Methods and FindingsWe utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA). We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male.ConclusionsDifferent combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported adverse drug reactions differed by gender. This approach using a large database for examining the associations can improve safety monitoring during the post-marketing phase.
Highlights
In the United States and Japan, the decision to approve a drug for clinical use is based on its having a satisfactory balance of benefits and risks within the conditions specified in the package insert
This approach using a large database for examining the associations can improve safety monitoring during the post-marketing phase
We evaluated the associations between adverse drug reactions and demographics using an apriori algorithm [16,17,18]
Summary
In the United States and Japan, the decision to approve a drug for clinical use is based on its having a satisfactory balance of benefits and risks within the conditions specified in the package insert. Information relating to a drug’s safety profile can change over time as its use is expanded in terms of patient characteristics and the number of patients exposed. A detailed evaluation of the information generated through pharmacovigilance activities is important for all products to ensure their safe use. Pharmacovigilance practices can improve information feedback to medical care providers and their patients in a timely manner, thereby reducing the overall risk to patients. With these ideas at the forefront, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) created the E2E guidelines for pharmacovigilance planning [1]. There have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender) has not been proposed
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