Skip to content

Month: January 2008

Oops. Let’s not blow this out of proportion!

A very overreactive rumor is being started as I type this about the FDA and Armour, and I think this whole topic needs to be leveled out. The rumor is as follows:

1) The FDA has stopped manufacture of all grandfathered drugs like Armour.
2) Armour will no longer be available at your local pharmacy

i.e. it’s being banned, discontinued, taken off the market, gotten rid off…you name it.

Now first let me clarify that all are totally and completely false. Forest Labs is still making Armour, and you can also find Armour at your local pharmacy, even if certain strengths are easier found than others.

Here is what is going on: In the January-February issue of the 2007 (i.e. a YEAR AGO) FDA Consumer Magazine, an article came out by Michelle Meadows titled The FDA Takes Action Against Unapproved Drugs. But this is NOT new news. This is based on the June 2006 release guidance by the FDA, called Marketed Unapproved Drugs–Compliance Policy Guide. What the FDA is doing is working to get unapproved drugs meet their approval guidelines.

What is an unapproved drug? For one, they are those drugs which were around before the FDA (Federal Drug Administration) came into existence in 1938, and these drugs were ‘grandfathered’ in with the subsequent FDA-approved drugs thereafter. (Armour is an example. Synthroid was too until it did what it took to be approved in 2002) Other examples, as explained in the January/February 2007 article, are when only one company may have approval to market a drug, but other companies are illegally marketing their versions of the drug without having gone through the FDA’s approval process. Another scenario is that a combination of ingredients is approved by the FDA, but a company is marketing a single ingredient without approval.

The article also clearly states: Before pursuing regulatory action against unapproved drugs, the FDA plans to consider the effects on the public health, including whether the product is medically necessary. The agency recognizes that some unapproved therapies offer benefits. An example is Phenobarbital, a drug used to control seizures. In some cases, FDA action requiring drug approvals will be gradual to avoid shortages of medically necessary products. In other words, whenever the day may come that Forest Labs is asked that Armour meet the regulations of the FDA, the process will be gradual and Forest will be given a fair deadline to do what it takes.

Kathy, a pharmacist with Forest Labs, reminds us that Armour has never been asked to go through that process (or they may not be admitting it yet so they can go through it in peace.). And if the day comes, they will do what it takes. Armour is a safe and life-giving product. And you bet your booties that even if it looked threatened some day, there would be a huge uprising from patients to stop it. But that’s not going to happen, just as it was for Synthroid where Abbott labs did what it took to be approved, and succeeded.

So, take heart: everything is fine. Armour is still being made. Your pharmacies still have it, even when some strengths are easier to come by than others. And I’ll keep you informed. And remember: I’ve always told you to stock up on your desiccated thyroid products anyway. 🙂

p.s. The root of the rumor comes from a recent recall by Forest Labs concerning its 3, 4 and 5 grain tablets, which had a 6-month potency problem, and a misunderstanding about it’s implications by individuals. Those tablets are currently scheduled to be out again by the end of January.

http://www.fda.gov/fdac/features/2007/107_drug.html
http://www.fda.gov/cder/guidance/6911fnl.pdf

***Want to spread the word and be your own thyroid patient advocate? Get your t-shirt here.

16 replies

The right way to find a good doctor!

A friend of mine, Kerry, recently confessed to me and a few friends that it was time to find a new doctor. Her normal one had been a disappointment for her far too many times. Time to move on.

And how she is moving on TOTALLY impresses me, and I think all of you reading this should consider this positively assertive and self-advocating strategy.

First, she scoured through her list of doctors on her insurance plan, and found one that looked promising. She called and spoke to his nurse on the phone. She then told us the following: I explained that I use Armour and refuse to change meds; I am VERY involved in my health; I watch my Frees carefully and don’t rely on the TSH at all since the feedback loop is interrupted by meds..etc. With that said, the nurse stated she would check with the doctor.

In other words, my friend Kerry refused to do what all of us have done most of our lives–approach the doctor passively. She clearly outlined who she is, where her intelligence is about her body, and that she expects a partnership, not a demi-god, one-sided dictatorship of what is right and what isn’t right for her health care.

She also stated that if this doctor didn’t come through, her next strategy was to write a letter about her health needs and how she wants to be very involved in her treatment, then fax it to every available doctor on her insurance list in her area and see if she gets someone calling.

MAJOR, HAND-CLAPPING BRAVO, Kerry!!

THAT, friends, is the way each and every thyroid patient should approach their health care: candid as to your beliefs about your treatment, and what you want from the doctor. And eventually, your assertive approach will produce a doctor who is going to be a gem for you! Remember: it’s YOUR body and YOU live in it.

p.s. Without an insurance plan? Pull out the Yellow pages! And don’t hesitate to use parts of this Dear Doctor template letter to help you flesh out and compose your words or letter.

***WANT TO MAKE A FASHION STATEMENT ABOUT YOUR THYROID TREATMENT? Go HERE for a thyroid advocacy t-shirt. I dare you to wear it to your doctors appointment. (But if you don’t, wear it everywhere else. It does attract questions.)

12 replies