Cardiologist & Obesity Medicine Specialist | Founder & Medical Director of Cardiometabolic Health/ myW8 | Healthcare Consultant | Advancing Heart Health through Evidence-Based Obesity Care
Read my Medscape article on the responsible use of compounded GLP-1s in Obesity care. Instead of a complete ban, we should guide their usage safely and in line with the FD&C Act. This approach can be especially beneficial for patients with cardiovascular disease during branded medication shortages. Check it out! #GLP1s #ObesityCare #FDCA #PatientSafety
As a newly minted ABOM Diplomate, I fail to understand how unstudied, unverified compounds satisfy the rigor of the CVOT trials, regardless of the state or federal “approval” of their use. The other approved AOMs have limited CVOT risks in good trials . I’ll be sticking to the FDA approved meds, and await the easing of manufacturing shortages.
"You cannot learn what you think you already know." – Epictetus Much of what some prescribers have stated in news stories and even here about compounded drugs is simply inaccurate and misinformed. As Dr. Einav indicates in his piece, FDA-approved drugs should ALWAYS be the first line of therapy. But it's simply not rational, fair, or compassionate to say to a patient when a life-changing medication is in shortage that they'll just need to do without – particularly when compounding pharmacies are using the EXACT SAME API made by the EXACT SAME CONTRACT MANUFACTURERS that supply the drug manufacturers and ADHERING TO THE EXACT SAME FORMULA used by the drug manufacturers (Fun fact: It's printed in the insert for the branded drug). True, compounded drugs are not FDA-approved. That's why they are not a first-line therapy. But FDA approval is no guarantee of safety, and absence of FDA approval does not mean unsafe. Is the risk higher? Perhaps. But it's a leap to jump from "higher-risk" to "unsafe." And all that bluster about not knowing what's in a compounded medication? Total nonsense. Compounded drugs come with a certificate of analysis attesting to purity, plus compounding labs submit their preparations for third party testing.
100% agree this is the correct approach. Well said
Founder and Chief Medical Officer knownwell. Bringing weight inclusive healthcare to all
9moAs you know, I as well as our national obesity organizations wholeheartedly disagree with your assessment of this urgent public health situation. You say that buying a “copy” of a semaglutide drug from an FDA approved manufacturer of other drugs: “This ensures the APIs' quality, potency, and purity, crucial for the safety and efficacy of compounded medications.” Yet it does no such thing and is a key issue. “Compounded drugs are not FDA-approved”. Buying a copied API that cannot be FDA approved and we have no data on its cardiovascular safety in my opinion is a risk that is too high to take when we have much proven safer treatments especially given the safety and efficacy of bariatric surgery. We have no data that these “copy” cat or counterfeit products work with the same degree as the original as they are not proven biosimilars at this point. And it is false to say that our other treatments have cardiovascular risks. We do not have that data as you know. In fact studies of Qsymia show positive changes, lower blood pressure, decreased waist circumference that align with improving cardiovascular risk factors. More patients should be counseled on surgery, our most well studied, proven treatment vs an unproven copied drug.