Today the FDA (US Food & Drug Administration) is removing many allergy, cough and cold products from the shelves of your pharmacy. If you have a favorite that has worked for you, perhaps you should stock up. What's going on? Well, it turns out that there are a ton of drugs out there that lack FDA approval, yet doctors and patients alike are unaware.
Why does it matter? Our FDA actually does a great job of collecting and reacting to adverse events related to medications, acting swiftly to remove products that could cause danger. Though there are not oodles of reports with this group of products, there are enough, especially considering that because most are over-the-counter, adverse events are much less likely to be reported.
Frankly, as I went through the list, I was very surprised that some drugs that I have previously written prescriptions for (like Entex PSE and Bromfed) are NOT FDA approved. The main reason I don't routinely recommend herbal treatments is their lack of FDA regulation, which means there is no guarantee of the amount of ACTIVE product in each tablet or capsule. Turns out, this could be true for any of these allergy, cough & cold remedies as well. Additionally, in the past couple of years, pediatric recommendations have changed greatly, especially for kids younger than two years. Many of these medications do not issue any such precautions.
Here are a few, but go to the FDA website for a full list: Accuhist DM, Aerohist, Allerx, Aquatab, Bromfed, Biotuss, Brovex, Carbodex, Deconamine, Duravent, Entex, Guaifenesin, Histex, Lodrane, Rescon, Ru Tuss, ZCof, etc.
Note that the Triamic brand and Robitussin brand are NOT on the list.
BOTTOM LINE: Go to the FDA WEBSITE and scan the list to be sure YOUR upper respiratory medicine of choice is NOT on the list!
2 comments:
It says on that FDA link that they are being removed because the manufacturers failed to keep up with the requirement to "register and list" these drug products with the FDA.
Surely it takes more than that to stay "approved".
Doesn't exactly give patients a lot of confidence in prescriptions or OTC's. I would say 99% of patients never do any research into medications being prescribed. We want to trust our doctors but the truth is that our doctors don't always have the up to date/correct information either as things can often change so rapidly. Time for docs and patients alike to do some homework and take the time to openly discuss medications together. ;-)
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