courtesy www.free-animations.co.ukDear Ones:
Anyone such as myself who has worked in the 'drug and cosmetics field' (like those who work in many other industries, as well) knows that the Federal Register is one's 'required reading' in order to keep current with FDA/HHS, EPA, DOT, etc. regulations.
The Federal Register becomes one's 'constant companion'. Here's today's issue if you're curious:
Complying with all the federal 'regs' (regulations) applicable to one's industry requires vigilance and a great deal of reading, no doubt about it.
Changes sometimes seem to occur at the whim and will of the federal 'powers-that-be' and at other times, they can seem quite reasonable.
But no matter, for such publications are 'law' and must be obeyed.
And as with most 'bureaucracy', the public-at-large may be left scratching their heads over what is going on, which is why I write what I do.
A number of the last two days 'headlines' read something like this: "FDA Orders Prescription Cold, Allergy Medicines Off the Market" with the blurb "FDA Orders 500 Medicines off the market"LINK: http://www.aolhealth.com/2011/03/02/fda-orders-prescription-cold-allergy-medicines-off-the-market/
Five-hundred Medicines...say what? According to original March 2, 2011 Federal Register Health And Human Services document itself.
"SUMMARY: The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved and misbranded oral drug products that are labeled for prescription use and offered for relief of symptoms of cold, cough, or allergy and persons who manufacture or cause the manufacture of such products. These drug products are marketed without approved applications, and many are inappropriately labeled for use in infants and young children. These drug products must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA), or comply with an FDA over-the-counter (OTC) drug final monograph, before marketing."
If you read this doc carefully, you will see the following drugs listed:
"Some of the products covered by this notice contain active ingredients that are in tannate salt form (tannate drugs). FDA has reviewed the publicly available scientific literature on these ingredients, and has determined that unapproved oral drugs labeled for prescription use and offered for relief of symptoms of cold, cough, or allergy that contain the following ingredients are not generally recognized as safe and effective (GRASE): Brompheniramine tannate;carbetapentane tannate; carbinoxamine tannate; chlorpheniramine tannate; dexbrompheniramine tannate; dexchlorpheniramine tannate; dextromethorphan tannate; diphenhydramine tannate; ephedrine tannate; phenylephrine tannate; pseudoephedrine tannate; pyrilamine tannate; and triprolidine tannate. Therefore, products containing these ingredients are new drugs within the
meaning of section 201(p) of the FD&C Act, and require approved NDAs or ANDAs before
A cursory reading would suggest that all of the standard 'cold, flu and allergy' drugs are being 'pulled', but that's not so.
It's only the 'tannate' form and is something your health care provider should be aware of and should advise you about. He or she must also not prescribe it any longer.
But, just on the off-chance that anyone is not being properly informed, let me break it down for you. It's not that confusing.
Most of the pharmaceuticals we use are formulated in a 'salt form', most commonly as a 'hydrochloride (HCl) or as a 'sulfate' (SO4), both of which allow the drug to be 'released' immediately in the humans and other mammals.
Sometimes 'immediate-release' medicines are good, but these do require regular 're-dosing'.
Enter the concept of 'time-release' formulations, such as 'specially coated tablets' and 'encapsulation technologies' ('tiny time pills') and the like.
Pharmaceutical chemists know that it is also possible to formulate the drug itself in such a way that it is absorbed more slowly (i.e. extended release) by fiddling with the chemical structure itself.
Enter the 'tannate' salt, as an alternative to the hydrochloride and sulfate salts so often used in drug formulation.
Tannates are prepared by reacting the drug 'free base' with tannic acid, resulting in a slow-release formulation for the drugs listed above.
Now Uncle Sam (the FDA, actually) is saying that these tannates have never been properly verified to be performing as stated, ergo the 'withdrawal' (or more dramatically, the 'banning of') 500 drugs.
The FDA is withdrawing them because the manufacturers are selling them without having gone through the NDA (new drug application) process required for prescription as well as for non-prescription drugs.
The intent of NDA requirement is that the 'efficiency and efficacy' of a drug be demonstrable and PROVEN....meaning, 'the drug's got to perform as stated'!
And since many of these 'tannates' are intended for pediatric use (use in infants and children), it is especially urgent that these cold, flu and allergy drugs be 'proven' before being administered to anyone at any age, let alone our littlest ones.
Please note that the drugs listed here themselves in free base form are not withdrawn, nor are their 'other salt forms', only the tannates which are 'prescription only' in the USA.
No 'OTC' (over-the-counter) drugs are affected. I guess you could say that some headlines are going for the 'spectacular', though in the world of 'Compliance', the FDA action under discussion here is not that unusual.
They (the FDA) have their eye on 'unique formualtions' such as extended release drugs, for the latter have the following drawbacks on any day:
-potential for 'sudden release'/overdose with improperly compounded medications
-potential for 'inadequate release/under-dosing with improperly compounded medications
-potential problems in the event of allergy to the drug itself
-potential allergy to the 'extended-release' component(s) itself.
Per the last above, there is always a certain amount of 'tannic acid' residue, albeit small, in the tannate compounds under discussion here.
Tannic acid is an astringent found in tea and is used to 'tan hides'. As used in the drugs formulations here, it is 'GRAS'-generally recognized as safe.
Still, it might be nice if the drug manufacturers would follow the dictates of the FDA and PROVE that all is well with residual tannin/tannic acid levels in their drugs while they're going about their NDA application business.
Looking out for you, I am
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"