Translation to English by Lindenmaier M and Brinckmann J
31. December 2001
Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)
1. Total Listed Cases
Referring to the non-official second listing of the BfArM as a foundation, there is a database of 32 side effect reports, including those reported by the Swiss health authorities (IKS), the WHO, as well as those cases described in the medical literature. The number of 32 reports is of course not synonymous to 32 cases of confirmed causality. The list contains duplicate reports and questionable classifications. When one collects all the available data for the individual cases, one arrives inevitably at another evaluation of the data.
2. Duplicate Entries
With a more accurate observation of the case reports listed by the BfArM, one finds a range of duplicate entries. Obviously, the duplicate entries were not reconciled against each other when the information was obtained from different sources. Therefore, the report of one and the same case can lead to a threefold entry, if, on the one hand, the event is reported directly from the patient, and on the other hand, the event is also reported via the manufacturer’s duty of notification, and finally, the treating phyisician also turns in a case report. These redundant data entries are not only difficult to recognize, but the inflated number of cases has led to a shift in the risk evaluation for a drug substance. In the case of the BfArM listings, mistakes in data transfer have exacerbated this situation.
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