Article
Adding pharmacogenetics information to drug labels: lessons learned.
Pharmacogenetics and genomics - 1 Dec 2006
Haga Susanne B, Thummel Kenneth E, Burke Wylie
Abstract excerpt
The US Food and Drug Administration approved a revised package insert for two cancer drugs to include information about the increased risk of severe adverse events owing to enzyme deficiencies caused by genetic variants. The label revisions stopped short of recommending or requiring pharmacogenetic testing prior to or following an adverse event. Despite (or because of) the lack of specific recommendations, we...
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