Public Citizen criticizes Medication Guides
FDA "started the important Medication Guide program off on the wrong foot" with the MedGuide for Glaxo Wellcome's Lotronex, because it is being used to "avoid the banning of a dangerous drug," Public Citizen Health Research Group Director Sidney Wolfe, MD, maintains in an Aug. 31 letter to FDA Commissioner Henney. "The Medication Guides shift too much responsibility into the hands of patients to promptly diagnose what could be, for them, a serious or life-threatening situation." Lotronex recently became the first drug required to include a MedGuide with each prescription (1"The Pink Sheet" Aug. 28, p. 3)
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