The 2009 FDA Ombudsman report, and why you need to contact the FDA
Good or interesting news is kinda slack right now.
But last week, the ombudsman of the FDA’s Center for Drug Evaluation and Research (CDER), came out with their 2009 report that I found interesting. The Ombudsman are those who receive and impartially look at any communications from patients to the FDA about medications.
On the fourth page, you find this under the heading Drug Shortages: Desiccated Natural Thyroid does not have FDA approval and it’s availability became quite limited in 2009. Many consumers complained to the ombudsman because of their preference of desiccated natural thyroid as thyroid replacement medication over the FDA approved synthetic versions.
Of course, the above gives a potentially false impression that the shortages were due to the lack of FDA approval–and reasons for this stupidity concerning “FDA-approval” are explained here.
To the contrary, last years shortages may be explained by production issues with the North American producer of desiccated thyroid powder, as well as demand being greater than supply thanks to patients finding out about the superiority of desiccated thyroid over T4-only meds like Synthroid. The STTM website and book is working, as are numerous good patient groups and forums!
But the above reveals that they are hearing thyroid patients speak.
So with this being a somewhat silent period, waiting to see when the FDA will require RLC (Naturethroid) to do ridiculously expensive clinical trials to prove what patients have already known for 110 years–that desiccated thyroid is safe and effective–it can be a GOOD time to continue communication with the FDA. How? By reporting YOUR EXPERIENCE AND PROBLEMS with T4 for their 2010 report next year. i.e. it will serve to cement why so many did call to state their preference. Here’s how:
- Call or fax them and report what happened to you on T4: 1-800-332-1088
- Fill out their form: http://www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf and fax or mail to MedWatch; 5600 Fishers Lane; Rockville, MDÂ 20852-9787
- Contact the FDA rep for your state: http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm
If you had depression or other psychological issues while on T4, report it.
If you have rising cholesterol, low ferritin, and/or low B12 because of T4, report it.
If you had dry skin or hair, digestive issues, or aches and pains, report them.
If the quality of your life was lowered on T4, report it, outline it, detail it.
If you got adrenal stress because of being on T4, underscore that lousy truth to them.
I have reported my problems with levothyroxine to the FDA. I got a call from Mylar, its manufacturer. I realized maybe it wasn’t such a good idea to give them a lot of info because they would probably twist it around and use it against us. Then, they sort of proved me right because I got a call from Forest Labs saying that Mylar told them I had a problem with Armour. That was flat out false. I still think we need to inform the FDA, but I think we need to be careful what we say to manufacturers of T4 medications. Of course, they are going to be snakes.