Infant cold medicines pulled for overdose risk

[Siageah]

These products were never designed to work on children. They were never tested for safety on children. And studies have shown that, in the dosage recommended for children under 6, that decongestants are ineffective. They will, very likely, either pull these products for children under 6 as well soon or will relabel them.

[MeAcHy]

Everyone should be very careful giving infants these medications my son (4 months old) passed away 4 days after meeting with his Dr. I was very percise in giving him the exact dose on time as the Dr. instructed me to do and he died from DM intoxication all of the other ingrediants that were in the medication were at theraputic levels and the DM was in the fatal level. We learned later that 10% of the population can't metabolize these ingeridents and the only ways to determan if your child is one in this 10% group is a blood test or they pass away. I recently learned that the some ingredents are beening used as a seditive for infants in these meds and is not helping them at all. I ask that everyone be really careful when giving any medications to an infant and pay attention to any changes in your child. (Screaming, loss of appitite, sunking of the eyes) DM is not safe for any child without a blood test first it is an opium derivitive and we should need a perscription to get it. It is in the same group as codine and we need perscriptions for that so why are our children being given these drugs OTC. These drugs are not helping they are covering the symptoms.

MeAcHy,
I am so sorry for your loss! No words can ease your pain. Thanks for providing the information amidst your grief.

Originally Posted by MeAcHy Everyone should be very careful giving infants these medications my son (4 months old) passed away 4 days after meeting with his Dr. I was very percise in giving him the exact dose on time as the Dr. instructed me to do and he died from DM intoxication all of the other ingrediants that were in the medication were at theraputic levels and the DM was in the fatal level. We learned later that 10% of the population can't metabolize these ingeridents and the only ways to determan if your child is one in this 10% group is a blood test or they pass away. I recently learned that the some ingredents are beening used as a seditive for infants in these meds and is not helping them at all. I ask that everyone be really careful when giving any medications to an infant and pay attention to any changes in your child. (Screaming, loss of appitite, sunking of the eyes) DM is not safe for any child without a blood test first it is an opium derivitive and we should need a perscription to get it. It is in the same group as codine and we need perscriptions for that so why are our children being given these drugs OTC. These drugs are not helping they are covering the symptoms.

[derketchup]

Originally Posted by austinmomto2 Mrs P, Thanks for the clarification that it is not a recall but a withdrawal. FYI: The Guaifenesin in plain Robitussin and generic forms is NOT a decongestant but an expectorant. Which is why our ped states that it is safe to use in children under 2. It just helps the congestion become more productive. However, every ped is different so my recommendation is to consult your child/ren's ped and see what they recommend.

When I think of "plain Robitussin", I immediately think of Robitussin Long-Acting Cough. The only ingredient it contains is Dextromethorpan, so in my mind that is plain. KWIM?

Guaifenesin is guaifenesin and has nothing to do with the trademark "Robitussin".

I just wanted to point this out because I don't want someone to read that it's okay to give their baby the "plain robitussin" and have the same assumption I did.

Very good point, Der ketchup! I also thought the same thing when my ped suggested the "plain robitussin". I immediately went to Robitussin long lasting cough and when I checked the ingredients it did not have ONLY Guaifenesin. Had I not looked at the ingredients to check that I was only getting Guaifenesin in the medicine, then I would have bought and used the incorrect one for my daughter. So, it just goes to show the importance of looking at all medication ingredients if you/ the dr choose to use them on the child.

Just for clarification, I wasn't suggesting that only Robitussin contained Guaifenesin. I know there are a lot of generic brands that contain Guaifenesin only. I was only using Robitussin as the product since it was one of the brands listed in the voluntary withdrawal.

Thanks again for clarifying, it is easy to make that assumption.

Originally Posted by derketchup When I think of "plain Robitussin", I immediately think of Robitussin Long-Acting Cough. The only ingredient it contains is Dextromethorpan, so in my mind that is plain. KWIM? Guaifenesin is guaifenesin and has nothing to do with the trademark "Robitussin". I just wanted to point this out because I don't want someone to read that it's okay to give their baby the "plain robitussin" and have the same assumption I did.

[kdownie]

Originally Posted by MrsPinecone Children under two are not supposed to get ANY form of decongestant. It usually does not help and can be harmful-- think heart palpitations, etc. Colds should be treated with nasal saline drops, the snot sucker (aka nasal aspirator), humidity and, if over 3 months, Vicks Baby Rub. Johnson's Vapor Cream can be used if over 6 months. This is not really a recall. My original title stated that it is a VOLUNTARY WITHDRAWAL of these meds.

So why would my DD's pediatrician say it was okay? I did try nose drops first, but she hated them. I guess I will just keep trying that.

Now I feel terrible! Thankfully, nothing has happened, but I gave her the pediacare decongestant drops just 2 weeks ago.

[kinc4]

Just received the email from Wyeth.




The appropriateness of cough and cold medicines for children is being discussed a great deal this cold and flu season. Wyeth Consumer Healthcare has important information to share with you on this topic since safety, especially for our young consumers, is most important to us.
Robitussin and Dimetapp cough and cold medicines are safe when used as directed. However, inaccurate or inappropriate use can lead to accidental overdosing. While this happens infrequently, children are the most vulnerable to overdosing. Therefore, Wyeth Consumer Healthcare has two very important messages for parents and caregivers:
For Children Under Age Two
We are no longer recommending the use of cough and cold medicines in infants and children under age two and are voluntarily taking the following infant products off the market:
For Children Age Two to Under Six
We are voluntarily recalling from the market the following products because the dosage cups enclosed do not have a half-teaspoon mark, which is the recommended dose for children age two to under six. Please be assured that this action is not related to the safety of the medication itself, but rather is due to the dosage cup markings only.
We recommend that parents and caregivers with children age two to under six do the following:

• Keep the product if it is intended for use in adults or children age six and over
• Do not use these medicines in children age two to under six because the dosage cups do not have a half-teaspoon mark, which is the dose on the label for this age group.
• Consult their healthcare professional concerning the most appropriate way to treat cough and cold symptoms for children age two to under six.
• Discard these Robitussin and Dimetapp medicines appropriately.

We are currently producing a new dosage cup with a half-teaspoon mark. These products are expected to be back on store shelves with the new dosage cups in November 2007.
This recall does not impact other Robitussin and Dimetapp cough and cold products. When used according to label directions, over the counter cough and cold products can be used safely in children age two and older, as well as in adults.
If you need more information about treating your child's coughs and colds, please contact your physician. If you have specific questions about our products, please contact us at 1-800-762-4675. And, as always, please read and follow all label directions carefully before using any medicines.
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[toppincl]

ok, so they're recalling the product, but not offering a replacement cup? And as a consumer, I should just toss it in the trash? I think not!!

Thanks for the heads up, but I have to admit I'm a little miffed right now :D I use a dosing syringe, since there's no way I could accurately measure and/or get my son to drink it from the cup, but they should at LEAST offer a replacement!!