Year: 2004
Type: article
Abstract: has to be reconsidered.Thirdly, we must find ways of preventing further similar episodes (box).Single phase III drug trials are simply not big enough to detect relatively uncommon but important adverse events, which may affect large numbers of people in routine clinical use.6 The potential public health impact of previously undetected drug related adverse events is likely to be made worse if widely marketed new drugs are prescribed haphazardly and rapidly to large numbers of people.Within five months of the launch of rofecoxib, more than 42 000 patients had been prescribed the drug in England, 11 even though newly marketed drugs carry a black triangle warning, indicating an incomplete safety profile.Unfortunately, postmarketing surveillance is not a panacea to determine safety, as methodological flaws may produce inaccurate results.We therefore recommend that drug companies are legally required to make all data on serious adverse events from clinical studies available to the public immediately after completion of the research.This will allow independent, timely, and updated systematic reviews of serious adverse events.In addition, we advocate the phased introduction of new interventions through randomised trials, which are independent from the pharmaceutical industry and are large enough to study rare outcomes, together with systematic, more robust, and comprehensive approaches to pharma-covigilance.12 Although these measures will not be popular with pharmaceutical companies, they will limit the numbers of patients exposed unsystematically to unknown hazards and provide robust and unbiased evidence on adverse events before a drug is licensed fully.
Source: BMJ
Authors: Erik von Elm, Matthias Egger
Institution: University of Bern
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: bronze
OpenAlex ID: W2144274361