On September, 29, 2023, FDA warned pharmacists and consumers alike about the dangers of compounded peptides. This included drugs commonly used in “peptide therapy” such as Ipamorelin, Ibutamoren GHRP-2, GHRP-6, Mesylate, Tesamorelin, CJC-1295, BPC-157, Semax Nootropic Spray, Melanotan II, MOTs-C, GHK-Cu, AOD-9604, IGF LR3, Dihexa, Kisspeptin, and Tesofensine. With few exceptions, the vast majority of these drugs do not have FDA approval and can’t be legally sold as compounded drugs or dietary supplements. Many of these peptides have little to no safety data. Others rely primarily, if not exclusively, on rodent studies. Some of these drugs have had their clinical trials halted when a test subject died. 

Whatever data exists for these substances, after years of consideration, the FDA has determined that it is inadequate to guarantee public safety. Some patients in peptide clinical trials have experienced complications such as cardiac arrythmias, decreased insulin sensitivity, congestive heart failures.  Others have experienced melanoma, posterior reversible encephalopathy syndrome, and sympathomimetic toxidrome.  Still others have experienced increased heart rate and systemic vasodilatory reaction. Because inadequate data exists on these peptides, it is not fully known whether these side effects arise from the substances themselves or impurities produced during the manufacturing process.

Additionally, many of these drugs present the patient with a significant chance of having an immunogenic response. An “immunogenic response” is a natural immune response causes the body to respond to the peptide by rejecting it the same way as the body would respond to a virus. This natural is dangerous because the structure of many of these peptides are based on natural hormones, causing an immune response attacking the body’s own hormones. For example, using peptides such as GHRP-2 or CJC-1295, which are essentially modified versions of natural growth hormone releasing hormone, could cause the body to no longer respond to this hormone. This could result in a temporary or permanent growth hormone deficiency and potentially force the patient to require lifelong corrective medication.

The final and most common side effects are caused by impurities in compounded peptide products. Peptides are complex molecules that require advanced manufacturing and sterilization techniques. Indeed, FDA has found impurities that endanger the public health in many of the peptide products examined. This problem is made worse by the fact that, as these drugs lack FDA approval, or an appropriate United States Pharmacopeia monograph which scientifically details the acceptable characteristics of the finished peptide. 

With limited data available to establish efficacy and safety, peptide therapy presents an unreasonable risk, especially for individuals with preexisting medical conditions that may be exacerbated by the use of illegal peptides.

‍