Recently, Major Pharmaceuticals issued a press release stating that the US Food and Drug Administration (FDA) has required them to cease production of a century old treatment option, a naturally dessicated thyroid drug , due to a change in FDA regulatory procedures.
Under their "Unapproved Drugs Campaign", the FDA is eliminating the regulations that previously allowed the production and distribution of these effective drugs. It has been reported that this action could have caused the shut down of manufacturing at two other firms. Additionally, the bioidentical hormone medications, which include Armour Thyroid and Nature-Throid, are on back-order at several other distributors. Ironically, there's also been a report of a national shortage of the Thyroid USP, the porcine desiccated thyroid raw material used to create the pills. No official information has been released by the FDA about the future of these prescriptions.
Use of these drugs formulations began at the turn of the 20th century, they never went through the various drug application processes that the FDA instituted because the drugs were already on the market. Thyroid patients have anecdotally reported that these prescriptions have fewer side effects and increased efficacy. Research results showed that patients with hypothyroidism may have improved brain activity and overall mood in comparison to those patients on Synthroid (thyroxine), the commonly prescribed synthetic thyroid hormone. (Bunevicius et al., 1999)
Health practitioners and patients have come together to strategize on keeping these much needed drugs on the market. The FDA is threatening a consumer's right to choose a natural treatment option.
Individuals concerned about availability of these drugs or the health of their thyroid should read more from About.com's thyroid expert Mary Shomon and the Save Natural Thyroid Coaltion.
(New England Journal of Medicine;1999;340:424-429)
For more info: Shortage Update
2 comments:
There seems to be a lot of panic about this natural thyroid situation and rightfully so. Hundreds of thousands of Americans rely on this to treat their hypothyroidism. Therefore, I think it is really important that Americans know that there is a natural thyroid product readily available in Canada. It is called ERFA Thyroid and can be found at Armour Thyroid Shortage
Actually they're not. While it's true that a couple of the smaller manufacturers like Major did stop production last summer due to issues with the FDA....but there were multiple issues.
The FDA's own drug shortage report says they are not http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm#thyroid
"FDA has not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market."
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