"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.
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
