Comment from Gieszl Dr. Scott

As a licensed physician for 47 years… and a patient taking Ozempic … I support compounded drugs in certain circumstances, including, for example, for patients requiring customized dosing or during periods of a shortage of an FDA approved drug as we experienced with GLP-1s. I am therefore troubled by the FDA’s recently reported increase in adverse events associated with compounded GLP-1s, including counterfeit GLP-1s directly marketed to patients at bargain prices. These are serious adverse reactions including numerous hospitalizations and deaths. I am not surprised at these developments given the explosion in doses of compounded GLP-1s in a population with pre-existing health risks from excess weight or obesity. We have at-risk patients taking FDA unapproved drugs … a predictable trigger for increased adverse reactions.. To be clear, every drug has side effects. The FDA does a good job assessing the side effects and risks of drugs before approval. However, the FDA does not review compounded GLP-1s. As a shortage of FDA-approved unfolded, the compounding industry commendably responded with attractively priced drugs. Fortunately, we now have an adequate supply of FDA approved GLP-1s. The problem now is the continued flow of cheap compounded GLP-1s, some counterfeit, and dangerous compounders’ marketing practices. Even worse is compounders adding ingredients never evaluated by the FDA for safety and/or efficacy. The FDA appropriately stepped forward and proposed excluding certain ingredients from the 503B bulk list for GLP-1s. The FDA’s action comes at the right time, not a moment too soon. I support the FDA decision. It is an appropriate response to the increasing number of adverse reactions. It is important the FDA keep with their obligations to protect our patients’ safety and health. George Scott Gieszl, MD, Board Certified in Anesthesiology