This article is based on the article, Compounded Semaglutide: Risks, Side Effects, and Insurance Coverage, published on healthline on September 6, 2024.
Semaglutide has gained significant attention as an effective medication for managing type 2 diabetes and promoting weight loss. While brand-name versions like Ozempic, Rybelsus, and Wegovy are widely recognized, compounded semaglutide has emerged as an alternative.
It is crucial to understand the differences, risks, and safety considerations associated with compounded semaglutide.
IT MAY BE BETTER TO DESIGN AND TRACK YOUR WEIGHT LOSS THE SLOW AND STEADY WAY
What is Compounded Semaglutide?
Compounding involves a pharmacy creating a customized medication by mixing or altering drug ingredients. This practice can be helpful during drug shortages or when a patient needs a specific formulation not commercially available.
Compounded semaglutide aims to provide a similar active ingredient to the branded medications but is not subject to the same rigorous FDA oversight.
The FDA’s Stance on Compounded Semaglutide
The Food and Drug Administration (FDA) generally advises against using compounded medications when an FDA-approved option is available.
This is because compounded drugs do not undergo the same safety and effectiveness testing as approved medications, potentially leading to contamination, mislabeling, or incorrect dosages.
The FDA has received reports of adverse effects, inconsistent ingredients, and fraudulent marketing related to compounded semaglutide. In some cases, compounded versions contained too little, too much, or no active semaglutide.
A case series in 2023 highlighted instances of gastrointestinal issues in individuals who received incorrectly administered compounded semaglutide from an aesthetic spa.
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Key Differences Between Standard and Compounded Semaglutide
- FDA Approval:
- Branded Semaglutide (Ozempic, Rybelsus, Wegovy): Yes
- Compounded Semaglutide: No
- Safety & Efficacy:
- Branded Semaglutide: Rigorously tested
- Compounded Semaglutide: Not regulated
- Manufacturing:
- Branded Semaglutide: Standardized
- Compounded Semaglutide: Varies by pharmacy
- Overdose Prevention:
- Branded Semaglutide: Prefilled injection pen
- Compounded Semaglutide: May lack safety features
Potential Risks and Side Effects
Compounded semaglutide carries potential risks due to the lack of FDA oversight.
Side effects associated with semaglutide, in general, may include:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Constipation
More serious complications can include pancreatitis, diabetic retinopathy, low blood sugar, and kidney injury.
Additionally, there are concerns about thyroid C-cell tumors based on studies in rodents.
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Semaglutide Salts
The FDA has raised concerns about compounding facilities using semaglutide salts (e.g., semaglutide sodium, semaglutide acetate) instead of the base form found in branded medications.
The FDA states that compounded versions containing these salt forms “have not been shown to be safe and effective”.
Making an Informed Decision
If you’re considering compounded semaglutide, it’s crucial to weigh the potential risks and benefits carefully.
The FDA recommends using FDA-approved medications when available.
If you opt for compounded semaglutide, ensure you do so under the guidance of a doctor.
Compounded semaglutide offers a potentially cheaper alternative to brand-name medications, but it comes with significant safety concerns.
The lack of FDA oversight, potential for inconsistent ingredients, and risk of adverse effects make it essential to proceed with caution and consult with a healthcare professional.
DISCLAIMER
This article provides general information and does not constitute medical advice. Consult your healthcare provider for personalized recommendations. If symptoms persist, consult your doctor.
