January 17, 2008
By Aaron Smith, CNNMoney.com
January 17 2008: 11:13 AM EST
NEW YORK (CNNMoney.com) -- The FDA warned parents not to give over-the-counter cold medicine to children under 2, because of "serious and potentially life-threatening side effects."
This warning affects drugmakers Johnson & Johnson (JNJ, Fortune 500), Wyeth (WYE, Fortune 500) and Novartis (NVS), but not by much, as over-the-counter medicine makes up just a sliver or those companies' sales.
For example, over-the-counter drugs make up less than one-tenth of Wyeth sales, and cold medicine for babies and toddlers make up a smaller fraction of those revenues. Also, the warning was expected, as the FDA has been investigating the use of cold medicine in children for some time.
"It reaffirms our voluntary recall in October," said Wyeth spokesman Doug Petkes. "We felt this was a way to reduce dosing errors, and overdosing in children, who we felt were the most vulnerable."
Les Funtleyder, analyst for Miller Tabak, said the sales impact on drugmakers is "limited."
"Higher value drugs and medical devices are more meaningful to sales than cold medicine," said Funtleyder. "I think more important issue here is not business, but public health. This will cause anxiety among parents because while there's a warning, there are no suggestions about alternate types of treatment or therapy."
The Food and Drug Administration said it was continuing to investigate the safety and effectiveness of over-the-counter cold medicine in children between the ages of 2 and 11.


January 17, 2008