NASEM Assessment on the Safety and Effectiveness of Compounded Bioidentical Hormone Therapy (cBHT)

readalot

Member

Email from FDA, emphasis added is mine. One could imagine what this may lead to...women especially may be affected since if T compounded creams go away then that leaves only the pellets or injections. I can tell you how challenging it is to get even a progressive Provider to consider sub-Q injections for a female :).

In recent years, we’ve become aware of a rise in the use of compounded hormonal therapy, often marketed and referred to as compounded bioidentical hormone therapy (cBHT), instead of FDA-approved drug products for hormone therapy. These cBHT products can contain hormones such as estradiol, estrone, dehydroepiandrosterone and testosterone. They are often advertised as having certain advantages over FDA-approved products, such as being derived from natural sources, being effective and safer than FDA-approved drugs that are synthetic or chemically modified, or not having the risks or side-effects associated with FDA-approved hormone therapies.

The agency has been concerned that health care professionals and patients may not be aware of the uncertainties of the benefits and potential safety risks with these compounded products. As a result, FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to organize an ad hoc committee to provide an independent assessment and evaluate the available scientific evidence relating to the safety and effectiveness of these products and discuss whether the available evidence supports use of cBHT products to treat patients (see the button for the free PDF on the right side of NASEM’s report webpage).

Based on its research and analysis, NASEM determined there was a lack of rigorous evidence of safety and effectiveness from well-designed or properly controlled clinical studies. NASEM found information about the safety and effectiveness of cBHT came mostly from low quality data, such as anecdotal claims, patient reports, and prescriber testimonies. Further, there is limited federal and state-level oversight of the quality and use of cBHT preparations. Given the lack of high-quality clinical evidence and minimal oversight of cBHT, NASEM concluded that their wide-spread use poses a public health concern.

FDA is reviewing NASEM’s findings to inform our next steps regarding cBHT. We will continue to work with compounders, regulators, healthcare professionals and patients as we develop policies that ensure continued access to compounded drugs for patients who need them, while also protecting patients from the risks of receiving a compounded drug when an FDA-approved product is appropriate for their medical care.

Finally, we are also requesting nominations for members to serve on the Pharmacy Compounding Advisory Committee, who provide advice to the agency on scientific, technical and medical issues concerning human drug compounding.Email



For more information, please visit FDA's Human Drug Compounding web site.

 

TucsonJJ

Member
IMO, the FDA is a disgrace... nothing more than a shill for the crooks of BIG PHARMA. I would ignore anything they said... and research it elsewhere.
 

Joe Sixpack

Active Member
Good grief. first they come after HCG and now it's T cream. Don't the pin heads in the FDA have something else to do with their time?
 

TucsonJJ

Member
Good grief. first they come after HCG and now it's T cream. Don't the pin heads in the FDA have something else to do with their time?
I bet they keep busy... torpedoeing any big discovery like a cancer cure... they are probably working hard for Evil Bill Gates' mandatory vaccination/depopulation dream right now...
 
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