Coping with confusion over kids cold medicines

by Anne Law, October 31st, 2007, 7:08 am

Last week I joined the ranks of confused parents wondering how to treat my child’s cold without resorting to the tried and true cold medicines. While my job at Hoover’s had already given me insight on the voluntary product withdrawal conducted earlier this month on selected pediatric medicines, I nevertheless struggled with my already overly cautious “mommy alert” about what medicines, if any, are safe for my kids.

General confusion caused by the withdrawal has yet to be cleared up. The FDA actions that led to this product recall and the pharmaceutical industry’s responses could have been been clearer, in my opinion. Here’s the low-down on what’s happened thus far:

• In response to a citizen petition submitted earlier this year,  the FDA put out a public health alert August 15 announcing that an advisory panel would meet in October to discuss the safety and effectiveness of children’s cough and cold medicines. The alert cited cases of over-medication and outlined recommendations for parents that can be summed up as: use age-appropriate medicines, read the labels, and consult your physician.

• In late September the FDA released expert reviews of certain medicines (those containing decongestants for children under 2 and antihistamines for children under 6) recommending that these products no longer be sold and that dosing cups and syringes be standardized.

• Industry trade group Consumer Healthcare Products Association simultaneously recommended that the wording “consult a doctor” be replaced with warning labels stating that the products should not be used for children under 2.

• In October pharmaceutical companies including Johnson & Johnson, Novartis, Wyeth, and Prestige Brands caved under public pressure and issued a voluntary withdrawal of selected pediatric multi-symptom medicines, primarily the “infant” variety aimed at children under 2.

• The advisory panel that met October 18-19 voted (21 to 1) for a ban on cold products for children under 2, voted (13 to 9) for a ban on multisymptom cough meds for children under 6, and unanimously recommended standardized dosing devices.

While the FDA is apparently in no hurry to make a final decision on the advisory committee’s recommendations, it is my sincere hope that the pharmaceutical companies will step up and make further efforts to fix these problems. As a parent, I wholeheartedly support an industry-wide consensus on confusing dosing implements. Redesigned labels with fewer happy baby pictures and stronger language, as well as company-funded studies on what medicines really do help sick kids, are steps that manufacturers should take now.

The use of pediatric cold medicines is based on the decades-old assumption that medicines work on children in the same way that they do on adults — an assumption that has been proven incorrect in many studies. Many experts maintain that cold medicines don’t even work on children. While I am skeptical about this conclusion, I do agree that drugs for children need to be proven safe FOR CHILDREN before they are put on the market.