Waxman: No OTC Meds For Kids Under 2
11 CommentsBy Ed Silverman // October 5th, 2007 // 5:25 pm
The California Democrat, who chairs the Committee on Oversight and Government Reform in Congress, is asking OTC makers to voluntarily relabel their products with a warning not to give the drugs to anyone under 2 years old, the Associated Press reports.
Although Waxman stopped short of asking the FDA to mandate an immediate label change, he did send a letter this week to a trade group representing Novartis, Johnson & Johnson and Procter & Gamble, among others, asking for voluntary label revisions. His letter comes not long after the FDA made a nonbinding recommendation that the drugs shouldn’t be taken by very young children. Current labeling directs parents to consult a doctor before administering the drugs to infants and toddlers and many doctors say they are safe to use, the AP notes.
In his Oct. 3 letter, Waxman questioned why companies haven’t already pulled products with the existing label off the market, citing J&J’s Tylenol Infants’ Drops Cold & Cough Plus as an example of a med that should be removed from store shelves. Similar treatments feature pictures of babies and come in dropper form, suggesting they are specially formulated for youngsters.
The FDA is reviewing the safety of the drugs at the request of Baltimore city officials, including the city’s commissioner of health, Joshua Sharfstein, a former staffer in Waxman’s office. The officials made the request after a study showed roughly 900 children aged 4 or younger who live in Maryland overdosed on these medications in 2004.
After reviewing reports of side effects over the last four decades, the FDA found 54 child fatalities from over-the-counter decongestant medicines. The agency found 69 reports of children’s deaths connected with antihistamines, which are used to treat runny noses. At a meeting set for Oct. 18-19, the agency will consider whether to formally request labeling changes.
The Consumer Healthcare Products Association submitted their response to Waxman’s letter to be considered at the FDA meeting. The letter says its members agree with limiting the use of these medications to children above the age of 2. “Member companies are no longer advertising or promoting these medicines for infants,” the trade group representing OTC makers, said in a statement. The companies are working to adopt the limited labeling recommended by the group and FDA.
In his letter, Waxman requests CHPA explain what steps it will take to sure the medications are not used in infants and toddlers.
Lisa Van S
Ed,
Someone should tell Waxman and FDA to ban antipsychotics for those age 18 and under……..
Bob
Ed,
Someone should tell Lisa to get a hobby or a man and calm down.
Lisa…No need to post in every article about antipsychotics.
We know your story. Relax.
Lisa Van S
Bob,
Is this a poor attempt on your part,.. at being a comedian?..
Bob
Lisa-Nope. If you’re going to post non-sensical drivel, then I’m going to follow you in every article and point it out.
Lisa Van S
Bob,
Ohhhh Boy,.. cant wait…
Donna
For all you Lisa Basher’s, has it hit home yet? maybe you should shut up until it do’s…you’ll know then…
Bob
Donna-I already know her story. It’s not that hard to use Google.
Blame the drug companies. Take no responsibility. Whatever makes you sleep better at night, I guess.
Lisa Van S
Bob,
When Industry cant defend their Drug…
They blame the Child…
How immature is that?!…
AA
Bob,
All you do is attack Lisa instead of explaining why her arguments are incorrect.
Speaking of personal responsibility, how do propose that kids who have no say in the psych drugs that are prescribed be able to do that?
How should Rebecca Riley have taken personal responsibility for the meds that killed her?
AA
Bob
AA-The parents are at fault.
the side effects aren’t hidden. But prove to me how Paxil can make one person carve themselves up, but the next person be perfectly normal. Obviously, there are much bigger issues (the person) that comes into play.
Laurie
“But prove to me how Paxil can make one person carve themselves up, but the next person be perfectly normal. ”
The same way that one blood pressure medication works on one person, and not on another. It’s called not being clones. These are drugs that have no defined method of action. Even pharma admits that they don’t know how these drugs work. Therefore every individual body/brain chemistry could, and does respond differently. You’r simplified thinking about brain chemisty, just highlights the lack of research on the subject. Brain chemisty doesn’t happen in a vacuum. When you effect one neurotransmitter you effect them all.
I’m sure it’s very reassuring to you that everyone who has had a bad reaction is lying. There are thousands of people who can dispute your thinking.