Pharmacy Times, Volume 0, 0

The breast cancer drug tamoxifen may have a new label warning. A panel of FDAadvisors has recommended that the agency add a warning that postmenopausalwomen who use the drug to treat breast cancer face an increased risk of recurrenceif they have the gene variation CYP2D6.

The panel left it to the FDA to determine whether the drug's label should recommendgenetic testing of postmenopausal breast cancer patients before they areprescribed the medication. The language on the warning may be in the form of asuggestion. The label change could take 6 months to put in place, according toLawrence Lesko, PhD, FDA pharmacology chief.