Is compounded Semaglutide FDA- approved?

Question

Hello doctor,

I am 43 years old and curious about compounded Semaglutide for weight management. I currently weigh 232 pounds at 5 feet 4 inches with a body mass index (BMI) of 39.8. I was diagnosed with polycystic ovary syndrome (PCOS) at 19, which has caused irregular periods, hirsutism, and acne despite multiple treatment attempts. I have also developed insulin resistance with a hemoglobin A1c of 6.1 percent, hypertension averaging 146/92 mm Hg while on lisinopril, and dyslipidemia with triglycerides of 276 mg/dL(milligrams per deciliter) and high-density lipoprotein (HDL) of only 31 mg/dL. Recently, I was diagnosed with moderate fatty liver disease with alanine aminotransferase (ALT) of 68 U/L and aspartate aminotransferase (AST) of 52 U/L. My family history is concerning, with my mother developing type 2 diabetes and having a heart attack at 52 years old.

I have tried numerous weight loss approaches, including medically supervised diets, intermittent fasting, phentermine (which caused insomnia and anxiety), and Contrave (which caused intolerable nausea). A fertility specialist has emphasized that weight loss is critical for improving ovulation and possibly achieving pregnancy, which my husband and I are still hoping for after years of trying. I attempted to get Wegovy (Semaglutide) through insurance, but my claim was denied because "obesity alone" is not covered, despite documentation of my metabolic complications. The out-of-pocket cost for Wegovy is approximately 1,350 dollars monthly, which is financially impossible with the current fertility treatment expenses. A local compounding pharmacy offers semaglutide at 285 dollars monthly, which might be manageable.

I would like to know if the compounded version is comparable in safety and effectiveness to FDA-approved products. Are there any concerns about quality control or consistency with compounded medications? How should we monitor for proper dosing and potential complications? What laboratory tests should be checked before starting treatment? I am desperate for an effective solution, as my health is deteriorating while conventional approaches have been unsuccessful.

Please help.

Thank you.

Answer 1

Hello,

Welcome to icliniq.com.

I understand your concern.

According to your medical history and your concern regarding treatment with Semaglutide.

First, I want you to explain in complete detail about Semaglutide, its mechanism of action, how it works, benefits, and possible side effects.

Semaglutide -

It is a glucagon-like peptide receptor agonist (GLP1 agonist) mimicking the function of the body’s natural GLP1 hormone.
This plays a vital role in regulating the blood sugar level by stimulating insulin production and suppressing glucagon (a hormone that raises blood sugar levels).
It works by imitating the effects of the GLP-1 hormone.
It also prevents the liver from producing excess glucose, thus aiding in maintaining a balanced blood sugar level.

Benefits-

Studies have shown that Semaglutide can effectively decrease blood sugar levels in adults with type 2 diabetes.
It has also been associated with weight loss as an added advantage for individuals with type 2 diabetes who are overweight or obese.

Side effects include nausea, vomiting, diarrhea, and abdominal pain.

The effectiveness of Semaglutide will be decided after thoroughly examining all your reports and physical conditions.

So do not take it on the advice of any random pharmacy. Please consult with a good doctor before starting it.

I hope this helps.

Kindly follow up if you have more concerns.

Thank you.