FDA warns of giving children cough, cold meds

mommy&wifeisme · **FDA warns of giving children cough, cold meds**

Interesting article.
FDA warns of giving kids cough, cold meds - Cold & Flu - MSNBC.com

treehugger · 09-29-2007, 08:26 AM

Quote:

Also on Friday, the FDA gave drug companies until Oct. 31 to stop making and selling any unapproved prescription medicines labeled for use by children younger than 6 that contain the painkiller and cough suppressant hydrocodone.

The move is part of a broader effort to remove from sale an estimated 200 unapproved prescription cough medicines made with the narcotic.

Manufacturers of any other unapproved hydrocodone medicines, beyond those intended for young children, must stop making them by Dec. 31 and cease shipping them by March 31, 2008, the FDA said. It said the order applies to most of the hydrocodone formulations sold as cough medicines.

I wonder which one's they are in?????

MXD · 09-29-2007, 10:51 AM

Quote:

Originally Posted by treehugger

I wonder which one's they are in?????

I think the article may be somewhat confusing. The medications they are talking about are all prescription.....and while the labeling may state "ok for use under 6" as a Pharmacist I have never seen a Dr prescribe a Hydrocodone-containing cough suppresant for a patient that young. On the flip side it's going to be another case of goverment regulation that causes a decent product to be removed from the market and the adults who are prescribed this won't be able to get it anymore.

It all boils down to which drug companies were willing to submit the proper
"paperwork" to have their products stay on the market.

Quote:

In most cases the products have been sold for decades, but in the 1960s Congress authorized the FDA to review drugs marketed from 1938 through 1962 to determine both safety and efficacy. In 1982, a hydrocodone cough syrup was reviewed as required by the Drug Efficacy Study Implementation (DESI) "and it was found to be safe and effective," Autor said. As a result of that action, all other hydrocodone cough syrups were required to submit to DESI review.

Seven companies did receive FDA approval for their products, but the rest -- more than 200 -- simply continued to market their products without approval. "They just took the shortcut,"

These 7 are approved:
TussiCaps, Tussionex/Pennkinetic, Hydrocodone compound by Actavis Mid Atlantic,
Mycodone by Morton Grove, Homatropine methlybromide and hydrocodone bitartrate by Actavis Totowa (same as brand name Hycodan),Hycodan by Endo Pharmaceutical
Homatropine methypromide by King Pharmaceutical

Some of the others that are apparently not approved are Histussin Hc, Vicodin Tuss, Codiclear, and their generics, etc.....

So I think maybe where it gets a little confusing is that they are not technically "unappproved" they are safe and effetive as drugs but the goverment just wanted the companies to prove their labeling "safe for under 6" and those additional companies chose not too (for whatever reasons)....but you also have to keep in mind I have never seen a Pediatrician write for a Hydrocodone based cough syrup....and I doubt they would just do it lightly, if ever.

My quote came from this article
Medical News: FDA Pulls Plug on 200-Plus Unapproved Cough Syrups With Hydrocodone - in Product Alert, Prescriptions from MedPage Today

summeranne · 09-29-2007, 01:18 PM

Hydrocodone - Wikipedia, the free encyclopedia has lists of medicines containing hydrocodone.

anniebananie · 09-29-2007, 01:29 PM

Thanks for the info MXD. My doctor, actually, has prescriped hydrocodone for my son last year (he was 5 then). 1/4 tsp at night, before bed. I am annoyed because it is yet another Government regulation that will only increase the cost of medications. Uugh.

penelope · 09-29-2007, 07:11 PM

I have stopped giving my youngest(3) cough medicine a while ago. And the only reason I ever gave her any is because my husband insisted. My doctor told me that they didn't really help. Just told me to give her lots of liquids. Honestly I don't ever remember an over the counter medication helping my children with their colds. Tylenol and Motrin is all that I will give my little one. The others are older now, but I still just give cold medicine at bedtime so they can sleep.