During this period, the FDA also issued warnings to a manufacturer regarding a levothyroxine sodium product that lost potency when stored at the higher end of the recommended temperature range, and one whose potency ranged from 74.7 percent to 90.4, instead of the 90 percent to 110 percent required at the time. Because these products were being marketed without NDA's, manufacturers had not had to file for FDA approval each time they reformulated their levothyroxine sodium products.Manufacturers had changed inactive ingredients, physical form of coloring agents and other product aspects, resulting in significant changes in potency, in some cases increasing or decreasing potency by as much as 30 percent.In some cases, problems result from the fact that levothyroxine sodium is unstable in the presence of light, temperature, air, and humidity.In the period between 19, there were no less than 10 recalls of levothyroxine sodium tablets involving 150 lots and more than 100 million tablets.80% of the effect is seen by two weeks, back to baseline by 4-6 weeks, assuming no dietary or caloric alterations. Read more There is no linear relationship to doses.Most studies are directed at levels of low density lipid (LDL-C) levels, with significant benefits in patients with known coronary artery disease and less (or no) benefits in patients without it who are considered to be at low risk.I never had a ultrasound or any lab testing to rule out cancer - pathology was negative.Post surgery I was kept hypo for many years - until I figured out how to dose my self, relying on where I fell in the FT-4 and FT-3 labs.
Implications for Patients What implications did these developments have for patients taking levothyroxine thyroid hormone replacement products?
In all but one case, the recalls were initiated because tablets were found to be subpotent or because their levothyroxine tablets lost potency before their expiration dates.
The remaining recalls were initiated for a product that was found to be too potent.
Early in the calibration phase post TT doses can be changed many times and they are nice to have on hand should you need to increase or decrease strengths. Remission was never going to happen for me so I opted for surgery to remove.
Final DX by surgeon was Hashitoxicosis, TPO antibodies over 2000 and TSI 316% within the year prior to surgery.
I remember reading somewhere (but of course I can't find it now) that Synthroid has a long shelf life, and one should not accept pills that are near the expiration date.