Important safety information
This page summarizes important safety information for the treatments our articles discuss. It is not a complete list of risks. Your clinician reviews your history before prescribing anything, and you should read the information that comes with your medication.
When to get help right away
Call 911 or go to the nearest emergency room for chest pain, trouble breathing, swelling of the face, lips or throat, fainting, or sudden weakness or numbness. Report side effects to your clinician, and you may also report them to the FDA through MedWatch at fda.gov/medwatch.
Sources: FDA MedWatch
GLP-1 medications (semaglutide, tirzepatide)
Compounded semaglutide and compounded tirzepatide are not FDA-approved and are not the same as brand-name products. The FDA has published its concerns about unapproved GLP-1 drugs used for weight loss (fda.gov).
GLP-1 medications are not for people with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2), and they are not used during pregnancy. The FDA-approved products carry a boxed warning about thyroid C-cell tumors seen in rodents.
The most common side effects are nausea, vomiting, diarrhea and constipation. Get medical help for severe stomach pain that does not go away, which can be a sign of pancreatitis, and for signs of a serious allergic reaction.
Sources: FDA: Concerns with unapproved GLP-1 drugs used for weight loss
Hormone therapy
Testosterone therapy is prescribed only after confirmed low testosterone on repeat morning blood tests. It can raise red blood cell counts and reduce sperm production, so it needs monitoring and is not the right choice for men trying to conceive without a discussion first. The Endocrine Society guideline advises against starting it in some men, including those with untreated severe sleep apnea (PubMed 29562364).
Menopause hormone therapy has benefits and risks that depend on age, time since menopause and health history, including risks of blood clots and stroke. Women with a uterus who take estrogen also need a progestogen to protect the uterine lining (The Menopause Society 2022 position statement, PubMed 35797481). Compounded bioidentical hormones are not FDA-approved.
Sources: Endocrine Society testosterone therapy guideline (2018); The 2022 hormone therapy position statement of The North American Menopause Society
Peptide therapy
Most peptides discussed in our articles are not FDA-approved. When prescribed, they are prepared by licensed 503A compounding pharmacies, and the FDA lists some bulk substances that may present significant safety risks in compounding (fda.gov). Peptides sold as "research use only" are not made or tested for people.
Common side effects include redness, itching or swelling where the injection is given. Get medical help right away for signs of a serious allergic reaction.
Sources: FDA: Bulk drug substances that may present significant safety risks in compounding
Questions
For questions about your own treatment, contact your Protocol Health clinician or email care@protocolhealthmd.com.
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Editorial policy · Medical review process · Important safety information · Richard Dentico, MD · Blog