As a thyroid patient who was profoundly harmed by the use of Synthroid and Levoxyl in the treatment of my hypothyroidism, and as an activist who sees this same harmful truth with potentially millions of other patients, I find this recent news interesting.
But you gotta wonder if they will be wearing noise reduction headsets and ear plugs…or not…when it comes to the scandal of synthetic T4-only medications. Will they?
Just today, the U.S. Department of Health and Human Services and the Food and Drug Administration (FDA) announced the Safe Use Initiative, “a program aimed at reducing the likelihood of preventable harm from medication use”.
Statements I gleaned from this initiative include:
1. Today, tens of millions of people in the United States depend on prescription and over”the”counter (OTC) medications to sustain their health–as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, even death, as a result of preventable medication errors or misuse.
2. Although FDA and many other stakeholders have been working to improve how the healthcare system manages medication risks in the United States, it is widely recognized that more needs to be done to protect the public from preventable harm from medication use.
3. Medications offer great benefit, but they come with risks. Whenever medications are not used optimally, risks of harm can increase significantly.
4. FDA proposes to identify, using a transparent and collaborative process, specific candidate cases (e.g., drugs, drug classes, and/or therapeutic situations) that are associated with significant amounts of preventable harm.
This initiative is actually far broader than what I gleaned above, and also involves self-abuse, exposure of dangerous medications to children, dire side effects, and more. Five areas are also specifically targeted: Consumer medication information (CMI), Medication dosing devices, Acetaminophen toxicity, Alcohol-based surgical preps, and Medications in vials. You can read more in the fact sheet.
But if the FDA is going to do their job with this initiative, or do their job overall, you have to wonder if they will listen to and include the problems associated with being treated with a T4-only medication as experienced by millions of patients worldwide. Continuing symptoms of hypothyroidism while on this inadequate treatment is widespread and damaging for many, causing hands reaching deep in pockets to pay for numerous doctors appointments, besides antidepressants, anti-anxiety meds, blood pressure meds, statins, cortisol meds for adrenal fatigue, and other medications which we would have never needed, and would have been preventable, if we had been on natural desiccated thyroid like Naturethroid or Westhroid in the first place.
Many patients on thyroxine, T4-only medications will also report actual hospital visits due to the side effects of a poor treatment.
In other words, thyroxine aka levothyroxine aka T4 treatment has been an unsafe and harmful treatment, causing millions to suffer unnecessary injuries and side effects for over 50 years of its useless and popular use. It fits the Safe Use Initiative. Or at the very least, it calls for the FDA to listen to patient experience with this lousy choice to treat hypothyroidism.
Listen to us, FDA. Listen and be wise.
P.S. See the blog post below about a genetic reason why so many do lousy on T4.
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4 Responses to “FDA’s Safe Use Initiative–think they will listen to our cries about T4-only meds?”
Leigh
Response to Sandy, just before me, questioning whether phrase “desiccated thyroid” is on the FDA website: yes, it is. Re-do the search using a format I learned from reading Google’s help-with-search pages: enter your search terms and then hit the spacebar and add site:fda.gov, which limits Google’s search to just the fda site. You’ll get about 10 hits.
And as for the safe use initiative, the FDA ought not create more work for itself – what it already does it does so badly – is there some way to say that without sounding like a crank?
Sandy
I don’t think the words natural or desiccated are even on the FDA website. I see what they suggest as the only treatment (synthroid & the like). I did a internal search on the FDA site for desiccated thyroid – the result list links lands you on The American Thyroid Association’s website. THEY say, “sold as a prescription, desiccated thyroid is illegal”. Having purchased it from my local Walgreens for the past three years, this was a surprise to me!
Dwayne
I doubt it. It’s all about money in the end.
Rose
I filed a MedWatch report to tell the FDA that I was harmed by use of T4 only treatment. You can do it online or they will mail you a form.
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
I think T4 medicines need a label that says, “Patient may still experience symptoms of hypothyroidism while taking this medication.” I think that’s what the FDA does – put warnings on medications.