Pharmacogenomics and adverse drug reactions

Adverse drug reactions (ADRs) observed during drug development have been the cause for discontinuing development of many drugs. In addition, serious but rare ADRs observed after marketing have led to withdrawal of some drugs. A priori identification of individuals at risk of developing ADRs for a given drug will help develop strategies to reduce the risk for ADRs in these patients. US FDA initiatives and efforts at reducing ADRs to make drugs safer are described, including updating of drug labels to include genomic information intended to reduce ADRs. Pharmacogenomics can also be harnessed to identify individuals at risk of developing serious ADRs and to treat these individuals with alternative therapy, thus converting ADRs that are traditionally considered unavoidable to avoidable ADRs.