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.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Clinical Pharmacology and Therapeutics |
| Vol/bind | 91 |
| Udgave nummer | 5 |
| Sider (fra-til) | 872-80 |
| Antal sider | 9 |
| ISSN | 0009-9236 |
| DOI | |
| Status | Udgivet - maj 2012 |
| Udgivet eksternt | Ja |