FDA Examining Safety of Kids' Cough and Cold Medicines

Mar 5, 2007 3:00 AM

WASHINGTON -- The Food and Drug Administration has started a broad review of the safety of children's cough and cold medicines after receiving a citizens‘ petition filed by a group of pediatricians and public health officials late last week. The petition cited a recent study of hospital emergency room records from 2004 and 2005 released by the Centers for Disease Control and Prevention, Atlanta. The study found that at least 1,519 children under age 2 had suffered serious health problems after being treated with common cough and cold medicines. Three of the children died, the agency found. Charles J. Ganley, director of the office of nonprescription drug products at the FDA, told The New York Times that most over-the-counter cough and cold medicines have not been sufficiently tested in children and the agency is "revisiting the risks and benefits of the use of these drugs in children," and that, "we're particularly concerned about the use of these drugs in children less than 2 years of age." The FDA also said it was too soon to predict whether the review will lead to new regulations. -- Wendy Toth