Infant cold medicines pulled for overdose risk

[MrsPinecone]

http://www.chpa-info.org/ChpaPortal/...CMedicines.htm

Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines

• Potential misuse of these infant medicines, not product safety, is driving the voluntary withdrawal
• This withdrawal does not affect cough and cold medicines for children age 2 and older
• Further evaluation of these oral cough and cold medicines for infants and children will occur at the October 18 and 19 FDA advisory committee meeting

Washington, D.C."The Consumer Healthcare Products Association (CHPA) on behalf of the leading makers of over-the-counter cough and cold medicines today announced voluntary market withdrawals of oral cough and cold medicines that refer to "infants." The voluntary withdrawal affects only these "infant" oral medicines, not those intended and labeled for use in children age two and older.
"Its important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," said Linda A. Suydam, D.P.A, president of CHPA. "The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."
The branded cough and cold medicines that are being voluntarily withdrawn are:

• Dimetapp® Decongestant Plus Cough Infant Drops
• Dimetapp® Decongestant Infant Drops
• Little Colds® Decongestant Plus Cough
• Little Colds® Multi-Symptom Cold Formula
• PEDIACARE® Infant Drops Decongestant (containing pseudoephedrine)
• PEDIACARE® Infant Drops Decongestant & Cough (containing pseudoephedrine)
• PEDIACARE® Infant Dropper Decongestant (containing phenylephrine)
• PEDIACARE® Infant Dropper Long-Acting Cough
• PEDIACARE® Infant Dropper Decongestant & Cough (containing phenylephrine)
• Robitussin® Infant Cough DM Drops
• Triaminic® Infant & Toddler Thin Strips® Decongestant
• Triaminic® Infant & Toddler Thin Strips® Decongestant Plus Cough
• TYLENOL® Concentrated Infants' Drops Plus Cold
• TYLENOL® Concentrated Infants' Drops Plus Cold & Cough

This voluntary withdrawal does not affect medicines intended for children age two and older. CHPA and its member companies have put forth recommendations to the U.S. Food and Drug Administration (FDA) to strengthen the labels on all oral OTC children's cough and cold medicines from "ask a doctor" before using to "do not use" in children under two years.

CHPA made these recommendations to the FDA in preparation for a joint FDA advisory committee meeting on October 18 and 19. These recommendations, as well as several additional recommendations, including those proposed by FDA review staff, will be explored further at this meeting.

"These medicines are and always have been” safe at recommended doses," Suydam said.

"These voluntary actions are being taken out of an abundance of caution. The vast majority of parents and caregivers safely use these medicines to help relieve their children's symptoms. But as with all medicines, it's important that parents read over-the-counter medicine labels carefully, use these medicines only as directed, and store them safely out of the reach of children."

CHPA will be launching a major, multi-year national campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children, partnering with major physician, nurse, and pharmacist organizations.

More information about the voluntary withdrawal can be found at www.OTCSafety.org.

Note to editors: Images of the group of products being voluntarily withdrawn are available at www.OTCsafety.org.

CHPA is the 126-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products.

[Cynthiabutterfly]

?

I don't get it.

Are they just not going to sell cough/cold medicine?

Are they going to keep it behind the counter with the antihistamines and only sell it after they give you a stern talking to about overdosing?

How weird.

[bexx09]

Infant cold medicines pulled for overdose risk
Nonprescription products for children under age 2
MSNBC News Services
Updated: 5:12 a.m. PT Oct 11, 2007

CHICAGO - Johnson & Johnson, Wyeth and other makers of infants’ nonprescription cough and cold products are recalling certain medicines in the United States because of the danger of overdose, the Consumer Healthcare Products Association said on Thursday.

Novartis and Prestige Brands Holdings are recalling their oral infant cough and cold medicines, as well, because data show that when the medicines are misused, it can lead to overdose, especially in children under the age of 2 years.

CVS Caremark Corp. is also removing the nonprescription products from its drugstores following the voluntary recalls.

The pharmacy chain said it will immediately remove all products subject to the recall as well as any store-brand equivalents. Customers who bought the products at a CVS store may return them for a full refund, the company said.

A spokeswoman for Consumer Heathcare, a trade association representing the makers of over-the-counter medicines, said overdoses have led to death and serious injury in rare instances.

In a statement, J&J's McNeil-PPC unit cited "rare instances of misuse", which could lead to overdoses.

The products being recalled include: infants' Tylenol Drops Plus Cold; Concentrated Infants' Tylenol Drops Plus Cold & Cough; Pediacare Infant Drops Decongestant; Pediacare Infant Drops Decongestant & Cough; Pediacare Infant Dropper Decongestant; Pediacare Infant Dropper Long-Acting Cough; and Pediacare Infant Dropper Decongestant & Cough (PE) products.

Cough and cold products for children age two and over and single-ingredient pain reliever and fever reducers expressly labeled for infants are not included in the recall.

The recall comes two months after the Food and Drug Administration issued a public health advisory warning parents not to give cough and cold medications to children under 2 years of age without a doctor's direction. The FDA's Nonprescription Drugs Advisory Committee will meet Oct. 18-19 to discuss the use of cough and cold drugs by children.

Safety experts for the U.S. Food and Drug Administration have urged the agency to consider a ban on these medicines for children under the age of 6 years.

Many experts say there is little evidence that these medicines are effective in such young children and are calling for mandatory warning labels that say the medicines should not be used in children under 2 years of age.

Questions about the products should be directed to McNeil's Consumer Relationship Center at 1-877-895-3665 (English) or 1-888-466-8746 (Spanish).

The Associated Press and Reuters contributed to this report

URL: Infant cold medicines pulled for overdose risk - Kids & Parenting - MSNBC.com

[jecca]

Originally Posted by Cynthiabutterfly ? I don't get it. Are they just not going to sell cough/cold medicine? Are they going to keep it behind the counter with the antihistamines and only sell it after they give you a stern talking to about overdosing? How weird.

I don't get it, either.
I think just about anything be "misused" and be dangerous.

[TheWoman]

The parent wakes up in the middle of the night because Junior is stuffy and can't sleep. She goes to the medicine cabinet and only has the stuff for 2 and older, and there are no instructions for how much to give her 1 year old. She doesn't want to call the doctor in the middle of the night over a stuffy nose, so she just guesses how much to give.

Sounds much more likely to be misused if the parent doesn't have proper instructions.

[terrynn]

From what I've heard, the infant meds are more concentrated than the liquid for older kids making it possilble to overdose. Someone brought a lawsuit against the manufacturer prompting the recall.

Mrs P and Bexx,

Thanks for the information! Very important to know.

My ped has provided my DH and I a dosage chart with different meds for the infant concentrated and children's products based on weight. This chart allows us to know the exact dosage to give our infant if we chose to use the children's formulation.

IMO, I am glad they are doing a voluntary withdrawal since I do not see the usefulness in cold meds for children under a certain age, especially infants. Again, this is just my opinion and it is only after long/informative discussions with our ped. I would hope, though, that since there is this recall the drug manufacturers and doctors will make it MANDATORY to provide parents with medication dosage charts.

Can someone rep, Mrs P, for me. I have given out too much rep in the last 24 hrs!

[TheWoman]

IMO, I am glad they are doing a voluntary recall since I do not see the usefulness in cold meds for children under a certain age, especially infants. Again, this is just my opinion and it is only after long/informative discussions with our ped.

My doctor agrees, and says that decongestants can actually make babies more likely to get ear infections.

I'm totally confussed. My daughter (9 mos.) is getting Robitussin cold right now. It is "pediatric" but does not have a dosing for under 2 years of age. So I was just taking the smallest dose and giving her half. (she has never had an ear infection or my other two toddlers ever) I don't see any problem with this and I'm probably going to get flamed for it but...
A 2 year old is not an infant. So many "infant" meds say do not use on children under two. Then what in the world are babies supost to get when their sick? My daughter has been extremely congested for a couple days and the Robitussin actually works awesome and keeps her clear so she can sleep without waking because she can't breath.
But as for this recall, what are they going to change? The label saying not to use it on children under two? What will that change? They still need to have something for infants to use.
I do also having a dosing chart for pain relivers but it does not include cold meds. Most drug compainies weren't comfortable saying these meds could even be used on infants so this information wasnt included.

So what should I do with my sick little girl? (please only advise, I'm not debating)