A group of seven of the largest drug manufacturers has formed a consortium to study the genetics of
serious adverse drug reactions.
The most commonly used national surveillance system for ADEs, the FDA Adverse Event Reporting System (AERS), is a passive surveillance system estimated to capture 1%-38% of
serious adverse drug reactions and influenced by such factors as length of time the drug has been on the market and media attention (5).
Serious adverse drug reactions were noted after marketing in more than 10% of 548 drugs approved between 1975 and 1999, according to Dr.
The company will also participate in several NCTR-led projects including the multi-year PADRE project (MAQC-IV), which is focusing on the modelling of drug-protein interactions to identify new genetic variations that may lead to
serious adverse drug reactions.
This figure compares favorably with the FDA's Adverse Event Reporting System, a passive surveillance system estimated to capture 1%-38% of
serious adverse drug reactions. It is a system which is influenced by factors such as the length of time the drug has been on the market and media attention, the CDC noted.
'Rare
serious adverse drug reactions, including serious liver reactions, are described in the product information.
hospitals estimated that approximately 2.2 million
serious adverse drug reactions and 106,000 fatal reactions were recorded in 1994.