Show I Cold medicines to warn against use bv by children under 4 Ceci Connolly The Washington Post I The makers of cold and cough medicines announced Tuesday they are voluntarily warning parents not to give their products to children under the age of 4 a move negotiated in private with federal drug regulators over the past six months Medications with the new warning labels will appear in hi stores and pharmacies immediately though experts continue to debate at what age the the over-the-counter remedies may be safe and effective The new labels also advise against using antihistamines to sedate youngsters Last winter the companies to discourage the use of the products in children under underage underage underage age 2 Each year yea drug companies sell 95 million packs of pediatric cold medicine generating about million in revenue More than man children are rushed to hospitals annually because of adverse reactions primarily due to accidental overdoses The include hives dizziness and difficulty breathing Industry representatives who face the prospect of an outright ban on marketing cold remedies for young children by the Food and Drug Administration said they took action because the majority of problems occur in 2 and year 3 We did this because we think its it's the right thing todo todo to todo do for parents said Linda Suydam president of the Consumer Healthcare Products Association She could not provide estimates on the financial impact of the decision Doctors who petitioned the FDA for broader restrictions applauded the new warnings but said they do not go far enough The products should not be available the over-the-counter at least up to age 12 said Wayne Snodgrass a pediatrician ian and clinical at the University of Texas Medical Branch at Galveston A year ago an FDA advisory panel voted to remove from the market all pediatric cold products for children under 6 I am disappointed that the FDA has not followed the recommendations of its own advisory panel Sen Christopher Dodd D said in a letter to Commissioner Andrew von Eschenbach Another cold and flu season is right around the corner comer yet commonly available medical products continue to be marketed and r sold to the parents of young children even though they have not been shown to be 1 1 effective and experts have 1 raised serious questions i about their safety Janet Woodcock director I of FDA's Center for Drug 1 Evaluation and Research said the agency is collecting j 1 more scientific information before making a decision Joshua the Baltimore public health commissioner who has led leda Ja J a coalition of pediatricians I advocating tighter restrictions said both the 4 industry and the FDA have havea a responsibility to educate the public on the new i 4 recommendations Its important that this i not just be an announcement but that the shelves reflect this policy as well he said in an interview In the meantime doctors are reiterating the unfortunate fact that researchers have yet to find a cure for the common cold wId There is no treatment said Michael Shannon director of the clinical pharmacology program at Childrens Children's Hospital Boston The best thing a parent cando can cando cando do is comfort measures such as fluids and rest Cough and cold medicines do not work |