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Key takeaways
Compounded semaglutide is not FDA approved, making its safety and effectiveness uncertain.
Differences in how it’s made or stored can make compounded semaglutide less effective.
Incorrect injection techniques and underlying health problems may slow weight-loss results with semaglutide or its compounded forms.
Consult a healthcare provider before using any form of semaglutide to ensure proper dosing and safety.
Semaglutide is the active ingredient in the brand-name medications Ozempic, Wegovy, and Rybelsus. It’s a glucagon-like peptide-1 (GLP-1) receptor agonist that was first approved to treat Type 2 diabetes. Wegovy is the latest brand-name version approved for weight loss in individuals who are overweight or have obesity with weight-related health conditions. As it became more popular for helping people shed pounds, demand skyrocketed.
Due to shortages and high costs, many people are seeking alternatives or cheaper options. Some online providers have started offering compounded semaglutide as a budget-friendly alternative. They claim it’s just like the brand-name drug but at a fraction of the price. However, people using compounded semaglutide may not see the weight loss they expect, for various reasons. Read on to learn more about compounded semaglutide, how it works, and why you might not lose the weight you’d expect to lose on it.
What is compounded semaglutide?
Compounded semaglutide is a custom-made version of the weight loss drugs approved by the Food and Drug Administration (FDA). It’s not the same as brand-name Ozempic, Wegovy, or Rybelsus.
Compounding pharmacists are allowed to compound certain medications when there’s a shortage of brand-name drugs or when the need to meet the specific needs of individuals. The process might include altering the strength of a medication, changing it from a solid tablet to a topical cream, or preparing a formulation that avoids allergens or certain inactive ingredients. For example, a person with a severe allergy to some dyes or fillers found in commercially available medications might benefit from a compounded version with different ingredients.
In the case of semaglutide, some pharmacists might compound the medication using the same ingredients as the brand-name versions. They might do this to help tackle shortages and capitalize on the demand for weight-loss treatments. Even without a shortage, compounded semaglutide may be marketed as an alternative, appealing to those looking for an affordable option and creating a lucrative opportunity for pharmacies.
Still, compounded semaglutide isn’t FDA approved. Its safety and effectiveness haven’t been tested like other prescription drugs. Compounded drugs are meant to fill gaps in care, not replace approved medicines.
How does compounded semaglutide work?
Compounded semaglutide is made to work like FDA-approved semaglutide. It’s typically prepared to help with weight management and blood sugar control, and it does so by mimicking a hormone called GLP-1 that our bodies make naturally.
GLP-1 helps control hunger and how the body uses food. It slows down how fast the stomach empties, making people feel full longer. Semaglutide also affects the brain’s hunger signals, which can lead to eating less food and fewer calories. Over time, using the drug may result in weight loss for some people. For those with Type 2 diabetes, semaglutide can help lower blood sugar levels by making the body produce more insulin when blood sugar is high.
Semaglutide has been shown to be effective for managing blood sugar and excess weight. In one study, people with overweight or obesity who took semaglutide lost around 6% of their body weight after three months and nearly 11% after six months.
Another study found that over about a year and a half, those taking semaglutide lost around 14% of their body weight on average, compared to only about 2% weight loss for those taking a placebo. The study also showed that semaglutide helped improve the body’s ability to process sugar and maintain healthy blood sugar levels.
However, there’s a catch. Compounded versions haven’t undergone extensive clinical trials to test their safety and effectiveness. Therefore, compounded semaglutide might not work as well as the real deal. In addition, while semaglutide can be helpful, it’s not a magic fix. Lifestyle changes such as dietary changes and regular exercise are still important.
Reasons for compounded semaglutide not working
Compounded semaglutide might not help everyone lose weight, and this could be due to several reasons. These can include problems with the dosage, meaning the amount taken might be wrong for some people. Additionally, each person’s body reacts differently to medications, affecting how well semaglutide works.
Wrong dosage
The right dosage is key for semaglutide to work well. Compounded versions might have a different strength than FDA-approved drugs, which can lead to taking too little or too much. Too little won’t help with weight loss, while too much can cause bad side effects. Compounded drugs may not have clear dosing rules like brand-name medications do. It’s easier to know if the dosage is right for you when you have the guidance of your healthcare provider.
Inconsistent formulation
Compounded semaglutide can vary from batch to batch. This means the drug may not be the same each time you get it. The active ingredient might not be mixed right, or it might break down fast. These changes can make the drug less effective, which is why FDA-approved drugs are often better, as the manufacturers must follow strict rules to make sure each dose is the same. Compounded semaglutide can be found in unique forms, such as nasal sprays, orally disintegrating tablets, and oral capsules. However, there’s a lack of large clinical trials proving how effective these different forms are.
Storage conditions
How the drug is stored also matters for how effective it is for weight loss. Heat, light, and moisture can all affect the stability of semaglutide. It might not work well if it’s not kept the right way. Without clear storage rules, compounded drugs may go bad faster than FDA-approved drugs, which can make them less effective or even unsafe. It’s difficult to know whether a compounded drug was stored properly before it reaches you.
Injection technique
How you inject the drug is important. If done wrong, the drug might not work as well. Semaglutide injections typically need to go under the skin, not into muscle or fat. Using the wrong needle or injecting in the wrong spot may cause problems. It might hurt more or not work as well. Without receiving adequate training on how to inject compounded drugs, people may make mistakes and achieve poor results.
Underlying health conditions
Some health problems can make it hard to lose weight, even with semaglutide. Conditions like hypothyroidism (underactive thyroid) and polycystic ovary syndrome (PCOS) can slow weight loss. Therefore, it’s important to talk to a healthcare provider about other health problems, so they can determine if something else is hindering weight loss.
Inconsistent use
Taking the drug the same way each time is key. Skipping doses or changing when you take them might make the drug less effective. It’s easy to forget or get off track with a new drug. Compounded drugs might not come with clear instructions, which can make it difficult to use them correctly. Keeping a schedule and sticking to it is important for the best results.
Individual body responses
Everyone’s body is different. Some people might not respond well to semaglutide, even if it’s manufactured as intended. It’s not always easy to know how you’ll react without trying it. Less-than-ideal responses can happen with any weight loss drug: Some people might lose weight fast, while others might not see much change. Talking to a healthcare provider familiar with your health history and any other medications you may be taking can help you decide whether semaglutide is the right choice.
Quality of compounding pharmacy
Not all compounding pharmacies are the same. Some might not follow the best practices, leading them to produce drugs that don’t work well or aren’t safe. Compounded drugs might be cheaper, but they might also be less reliable. Furthermore, as drug shortages end, these compounded options might not be available or allowed.
Compounded semaglutide might not work for everyone due to various reasons. These reasons can differ from person to person based on the person’s overall health and other factors. If you’re not getting the desired results, it’s important to talk to your healthcare provider.
How long does it take to see compounded semaglutide results?
Seeing results from compounded semaglutide can take time. It can take four to five weeks for semaglutide to reach steady-state levels in the blood. Steady-state levels are achieved when the amount of the drug in your body stays constant because you are taking it at the same rate that your body is removing it.
Most people taking a semaglutide subcutaneous injection or oral tablet start noticing changes within four to eight weeks of starting treatment. However, weight loss is usually gradual. Some might lose 5% to 10% of their body weight in the first few months, while others might take longer to see changes.
Much of the research on the time frame for weight loss is based on clinical trials conducted for the FDA-approved brand-name versions. Because compounded semaglutide isn’t FDA approved, its effectiveness and the amount of time ita takes to work can vary.
Patience is key in any weight loss journey. Quick fixes rarely lead to lasting weight-loss results, especially without lifestyle changes like a nutritious diet and regular physical activity. While many may be tempted to take higher doses to achieve more significant weight loss, doing so may increase the risk of serious side effects.
Is compounded semaglutide safe?
The safety of compounded semaglutide is hard to guarantee. The potential risks with compounded drugs are numerous, especially if you don’t choose a reliable compounding pharmacy. These risks might include:
- Incorrect dosing
- Contamination
- Unknown side effects
- Allergic reactions
- Unapproved ingredients
- Ineffective formulation
- Inconsistent quality
- Risk of infection
Online platforms that offer a prescription for compounded semaglutide might do so without requiring a consultation. Some online prescribers might not fully check a patient’s health history, which can lead to adverse events.
One of the biggest concerns with using compounded semaglutide is dosing errors. The FDA has reported serious cases in which people accidentally took too much of the medication, sometimes requiring hospitalization. Many people who self-inject might not be familiar with how to measure their doses correctly.
If you’re considering compounded semaglutide, make sure to seek medical advice from your healthcare provider about how to properly measure and administer a dose. It’s also important for your healthcare provider to prescribe the right strength and dosage, as compounded semaglutide can come in various forms. They can help weigh the risks and benefits of using compounded medications. With your healthcare provider’s clear instructions and training on using syringes, you can prevent mistakes and more effectively reach your weight-loss goals.
The bottom line
Compounded semaglutide is a custom-made version of a weight loss medication that some people might find appealing because it can be cheaper and more available than FDA-approved options. However, it might not work as well as the approved versions and can be less safe due to issues like uneven mixing of ingredients, wrong doses, and unproven dosage forms.
While some people might lose weight over time, the fact that the FDA hasn’t approved compounded semaglutide raises concerns about its quality and safety, including risks like contamination or incorrect dosages. It’s important to talk to a healthcare provider to make sure the treatment is safe and effective and to explore other options that might be better for you.
Sources
- Weight loss outcomes associated with semaglutide treatment for patients with overweight or obesity, JAMA Network (2022)
- Changes in glucose metabolism and glycemic status with once-weekly subcutaneous semaglutide 2.4 mg among participants with prediabetes in the STEP program, Diabetes Care (2022)
- What causes obesity & overweight?, Eunice Kennedy Shriver National Institute of Child Health and Human Development (2021)
- Compounding and the FDA: Questions and Answers, Food and Drug Administration (2024)
- Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes, Reviews in Endocrine and Metabolic Disorders (2022)
- FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products, Food and Drug Administration (2024)
- Thinking of using a compounding pharmacy? What you need to know, Harvard Health Publishing (2024)