Big pharma will be taking a voluntary hit in its $300 million over-the-counter market for children's cold medicines. While readily available at drugstores everywhere, physicians and other experts have repeatedly called their safety and efficacy into question, although the Consumer Healthcare Products Association (CHPA)--a cold-medicine industry group--maintains the drugs are safe when used appropriately. CHPA represents major drugmakers including Johnson & Johnson, Procter & Gamble and Novartis.
Leading manufacturers of the medications will change the labels to say, "do not use" in children under the age of four, as well as add language to medications containing antihistamine products essentially telling parents not to drug their children for the purposes of helping them sleep. Major companies like McNeil Consumer Healthcare (a division of Johnson & Johnson that makes Children's Sudafed, Children's Benadryl and PediaCare cough and cold medicines) and Wyeth (which makes Dimetapp and Robitussin cough and cold medicines) were among the pharma giants spearheading the voluntary effort.
While some groups, including physicians' groups, requested a ban on the medications for all children under the age of six, the FDA rejected the plea on Monday. On Tuesday, however, drug companies took an ethical leap anyway and publicly advised parents not to use OTC cough and cold remedies in children under the age of four. A previous advisory recommended against giving the medications to children under two and drug companies pulled all infant cough and cold meds off the market a year ago. Some say the hesitancy of the FDA to initiate a broader ban might rest on fears that, without the children's option, desperate parents might try to give children adult medications to relieve symptoms.
Prominent physician groups, including the American Academy of Pediatricians, say the research is weak on the drugs and that, considering the risks and the dearth of safety and efficacy information, there isn't a solid reason to use the medications in children under the age of six. In fact, an earlier CDC study found that each year approximately 7,000 children ages 11 and younger (with most between two and five years) end up in the emergency room after ingesting cough and cold medicines designed for children. Likewise, there were reports of 10 infant deaths associated with OTC cold medicines in 2006, according to Arizona researchers.
A spokesperson for Johnson & Johnson in Canada said that the company will not put the warnings on Canadian products, however.