No OTC Cough & Cold Meds For Small Kids
4 CommentsBy Ed Silverman // October 7th, 2008 // 2:04 pm
An industry trade group, which represents such drugmakers as Procter & Gamble, Novartis and Johnson & Johnson, unexpectedly declared that several very popular over-the-counter cough and cold meds for children younger than four years old should not be used because of the risk of rare complications associated with inappropriate use.
The voluntary move comes just one week after an FDA meeting was held in which a group of doctors and consumer advocates cited ineffective and even dangerous meds for small children as justification for an all-out ban. The Consumer Healthcare Products Association maintains that dosing errots and accidental ingestions - not the safety of the meds - are to blame for serious adverse events.
“We’re doing this out of an abundance of caution,” Linda Suydam, the CHPA’s president, tells Reuters. Here is the statement from the group.
The industry group is limited its ban to children younger than 4 because an analysis showed most problems occurred in 2-year-olds and 3-year-olds, Suydam adds. Meanwhile, the drugmakers are shipping meds with packaging that cautions parents not to give the products to youngsters. The move only applies to syrups, pills and tablets, but nasal sprays, inhaled medicines, lotions or rubs.
Last January, the FDA issued a public health advisory that the drugs should not be given to children younger than 2 years old. Among the meds - Novartis’s Triaminic; Johnson & Johnson’s Tylenol and PediaCare; Wyeth’s Dimetapp and Procter & Gamble’s NyQuil. All available for decades, the meds may increase the risk of hallucinations, stroke and seizures, among other things, often because of dosing errors. They also have never been proven to work, some docs say.
The drugs were allowed on the market under rules for over-the-counter products that do not require data showing safety and efficacy. Instead, data were extrapolated from adults. And industry reps rejected concerns, saying the meds are safe for children over 2 years old when used as directed.
FDA officials have already banned marketing of the products to children younger than 2 and told reporters in a teleconference this afternoon that they plan to review trial data about safety, dosing and effectiveness in about six months. Later, the FDA plans to issue a rule covering more specific usage.
Nathan
This is so absurd… I’m going out to the store and stocking up on cold medicines for my toddlers. A few stupid parents who can’t read labels end up making life harder on all of us.
So far I have not seen any evidence that these drugs cause negative effects when used according to the label. Moreover, there are not studies that show that these drugs are INEFFECTIVE in toddlers. Rather, there are no studies showing them to be effective OR ineffective. But, as almost any parent who has used them can testify, they DO work.
Chris
On the rare times we needed them, we never found them to be effective, anyway. Simple things like using a humidifier seem to do the trick just as well.
A shoutout for breastfeeding: the best prevention and it shortens duration of illness, too!
Julie
I agree with Nathan. We all know that the medicines do not shorten the duration of the cold, but help the child feel better and get the rest they (and us parents) need. They absolutely work!
My kids are older than 4 years old now TG, so I can only sympathize with those parents and kids that this ruling will undoubtedly affect in a very negative way. This decision will keep kids out of school more days, keep parents out of work, cause unnecesary suffering for the kids and the parents, and no one will get any sleep.
I will also be one in line purchasing as many of these meds as I can to stock up - either that or have to run to Mexico to get them!
Getting really tired of the “nanny” mentality of these agencies who make absurd decisions liek this.
nipsey russell
errr….they are changing the labeling. you two are going to “stock up” on medicine now because you dont want to buy the medicine later with a different label? weird!