‘Tis the season for runny noses and nasty hacking, especially among kids, but the recent hoopla about the safety and necessity of over-the-counter remedies is giving drugmakers a cold sweat.

Normally, this is a $300 million-a-year business, but sales are slowing since product withdrawals began Oct. 11 of OTC meds for children less than 2 years old, The Chicago Tribune reports. And a week later, an FDA advisory panel decided that kids ages 2 to 6 also shouldn’t use various antitussives, decongestants and antihistamines because pediatric effectiveness hasn’t been studied and the risks outweigh benefits.

And so unit volume sales of children’s OTC remedies were down 0.3 percent, to 9.16 million, for the 10-week period ending Oct. 20, while dollar sales are up a little less than 1 percent, to $54 million, according to marketing information from Nielsen. By comparison, dollar sales and unit sales were up 14 percent and 12 percent, respectively, during the same period from 2005 to 2006.

“Parents who rely on cough and cold medicines are expressing frustration,” Melissa Davies, research director for Nielsen subsidiary Nielsen Online, tells the paper. “There were a lot of fence sitters who wondered whether this stuff worked who have been swayed (not to use cough and cold meds for their kids).”

UPDATE: Three DC pols - Henry Waxman, Ted Kennedy and Tom Allen - today introduced a bill that would allow the FDA to revoke authorization to market OTC drugs without having to follow enact lengthy rules needed to follow the FDA panel recommendation. “The pediatric cough and cold medicine debacle has shown us that FDA’s authority over OTC drugs is seriously outdated,” says Waxman. Here is the bill and a fact sheet.

Some docs say the publicity turning consumers away is a good thing. “I find that less people are asking me about what they should do when their child has a cold,” Joel Schwab, associate professor of pediatrics at the University of Chicago, tells the Trib. “You don’t have to go out at 1 a.m. to the White Hen and get something that is expensive that may not work anyway, so this is good news that fewer people are using them.”

You can read more here.