Safety Learning From Drugs of the Same Class: Room for Improvement

Abstract

This study was aimed at assessing the extent of safety learning from data pertaining to other drugs of the same class. We studied drug classes for which the first and second drugs were centrally registered in the European Union from 1995 to 2008. We assessed whether adverse drug reactions (ADRs) associated with one of the drugs also appeared in the Summary of Product Characteristics (SPC) of the other drug, either initially or during the postmarketing phase. We identified 977 ADRs from 19 drug pairs, of which 393 ADRs (40.2%) were listed in the SPCs of both drugs of a pair. Of these 393 that were present in both SPCs of a drug pair, 241 (61.3%) were present when the drug entered the market and 152 (30.7%) appeared in the postmarketing phase. The mention of ADRs in the SPCs of both same-class drugs in the postmarketing phase was associated with type A ADRs, marketing in the same regulator country, a longer time interval between entry into the market by the two drugs, and an earlier date of ADR. Although there appears to be some degree of safety learning from same-class drugs, there is still room for improvement, possibly by increasing proactive risk management.

Analysis of Safety-Related Regulatory Actions for New Drugs in Japan by Nature of Identified Risks

“…All these suggest that decisions on SRRAs are likely to be prompted by a group of drugs with the same MOA, as class effects are identified. Information related to ADRs is commonly shared by drugs with the same MOA in the summary of product characteristics [ 14 ]. Together with the finding that launch lags seem to decrease SRRA risks, our results suggest that managing the risk of novel new drugs on new markets is a vital issue.…”

Risk Management Plans as a Tool for Proactive Pharmacovigilance: A Cohort Study of Newly Approved Drugs in Europe

“…Products: Medicinal products were classified into related therapeutic groups on the basis of the first level of the Anatomical Therapeutic Chemical classification system (http://www.whocc.no/atc_ddd_index/). To determine whether products were first in class, all products were further categorized into subgroups consisting of products with the same indication and target receptor, similar to the method used by Stefansdottir et al 38 …”

“…Products: Medicinal products were classified into related therapeutic groups on the basis of the first level of the Anatomical Therapeutic Chemical classification system (http://www.whocc.no/atc_ddd_index/). To determine whether products were first in class, all products were further categorized into subgroups consisting of products with the same indication and target receptor, similar to the method used by Stefansdottir et al 38 Safety concerns: In the RMP, safety concerns are classified as "important identified risks, " "important potential risks, " or "missing information" ( Supplementary Table S1 online). Information on the status of each safety concern was extracted from the baseline RMPs and subsequent postapproval updates.…”

Factors distinguishing important identified risks from important potential risks in orphan and nonorphan drugs: An analysis of safety specifications of Japan and European Union risk management plans

“…In the EU, no significant association was observed for both orphan and nonorphan drugs, which may be plausible given that EMA guidelines on RMPs state that possible class effects should be addressed as important potential risks . Considering a previous study reporting that the majority of ADRs listed in the SPC were not shared between drugs of the same class, the EU put less emphasis on ADRs known in similar drugs than Japan.…”