EarplugsAs 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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  • Check out the patient-to-patient book with even more detail (and which doc­tors seem to res­pect more than websites).
  • Need to unders­tand all your best options for thy­roid treat­ment? Go here.
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4 Responses to “FDA’s Safe Use Initiative – think they will listen to our cries about T4-only meds?”

  1. Rose said:

    Nov 04, 09 at 2:46 pm

    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.

  2. Dwayne said:

    Nov 05, 09 at 6:05 am

    I doubt it. It’s all about money in the end.

  3. Sandy said:

    Nov 18, 09 at 2:49 pm

    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!

  4. Leigh said:

    Nov 20, 09 at 5:21 am

    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?


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