ABSTRACT

Communication to the public of medical product risks, such as drug-grapefruit juice interaction, is an important aspect of public health agency work. Health Canada, for example, advised the public in 2002 (1) not to consume grapefruit products with medications used for certain medical conditions, such as anxiety, depression, and others. In the United States, the Food and Drug Administration (FDA) includes documented information on drug-grapefruit juice interaction in individual product labeling [also known as the package insert (PI)]. The process that the FDA uses to include such interactions in product labeling is reviewed in Chapter 10.