Is Compounded Semaglutide Safe? Understanding the Risks and Benefits

Losing weight can be extremely difficult when you arrive at a point where diet and exercise aren’t working. With the obesity epidemic showing no signs of slowing down, many are interested in new treatments. 

A recent promising solution for weight reduction is semaglutide. Because of its recent shortages, compounded semaglutide has become more common. But is it effective? What are its advantages and risks when used for weight loss? Read on to find out.

What Is Compounded Semaglutide 

Semaglutide belongs to a class of medications called GLP-1 (i.e., glucagon-like peptide-1) receptor agonists. It slows down gastric emptying, improves satiety, and regulates appetite. Initially, semaglutide was prescribed to patients with type 2 diabetes due to its ability to control blood sugar. With time, some of its brand names, such as Wegovy, have also been approved for weight management, while others, like Ozempic and Rybelsus, can be prescribed for weight loss off-label. 

Compounded semaglutide works the same way but differs in its manufacturing process: it is produced in pharmacies and altered according to the individual patient’s needs. Since ingredients are combined outside a standard manufacturing process, there is a risk of having lower or higher doses of semaglutide and differing inactive ingredients, which may influence effectiveness and side effects.

Compounded medications do not have FDA approval because they haven’t gone through extensive clinical trials to establish their safety. Although they can be prescribed when FDA-approved versions are unavailable according to a drug shortage list. When you receive a semaglutide prescription from the doctor, remember to ask about all available options to choose the most suitable one collaboratively.

Is Compounded Semaglutide Safe to Use for Weight Loss?

The FDA has received various reports claiming the adverse effects of compounded semaglutide for weight loss. These versions are not regulated, hence, there is a risk of dosage errors and contamination and fewer safety guarantees. For example, According to the FDA, compounders use salts of semaglutide like semaglutide sodium and semaglutide acetate; this method is not recognized by the agency and does not fulfill FD&C requirements on utilizable active ingredients.

It is preferred that in the presence of approved medications, their compounded versions are not used due to these risks. Also, since the quality of compounded medications varies, there is a lower possibility of consistent results for weight loss. If there is still a need for compounded semaglutide, it is recommended to obtain it in specially accredited pharmacies. 

Compounded Semaglutide vs. Ozempic, Wegovy and Other Weight Loss Medications

Regulation and Approval

The biggest difference is that Ozempic, Wegovy, and other brand-name weight loss medications are regulated and approved by the FDA while compounded semaglutide is not. These medications have undergone elaborate clinical trials before being introduced into the market. This ensures their quality, safety, and efficacy. The quality and effectiveness of compounded semaglutide vary over compounding pharmacies.

Cost

Brand-name medications like Ozempic and Wegovy are more expensive than compounded versions of semaglutide, especially if the individual lacks insurance coverage. On top of that, these medications involve high out-of-pocket costs.

Availability

In terms of availability, standard semaglutide can be accessed from any pharmacy but compounded semaglutide is only available in compounding pharmacies. However, the shortages of brand-name medications have increased demand for compounded semaglutide.

Risks and Effectiveness

The risks associated with brand-name medications are known, well-studied, and included in the label, which is not the case for compounded medications. Clinical trials also show their effectiveness; for example, this study states that individuals can lose 5.9% of initial body weight in 3 months and 10.9% in six months of taking semaglutide.

At the same time, there are no studies assessing the effectiveness of compounded semaglutide because it is manufactured in different pharmacies with slight differences. Also, because of the medication’s potentially different formulation, risks and side effects of compounded semaglutide may impact its effectiveness for weight loss.

Where and How to Get Prescribed Semaglutide (Not Compounded)

Just like its compounded version, standard semaglutide under brand names Ozempic, Wegovy, and Rybelsus requires a prescription. These prescriptions can be issued by licensed healthcare providers such as doctors or nurse practitioners, either in walk-in clinics or through telehealth platforms. During a consultation, a healthcare provider will assess your medical history and eligibility requirements and prescribe weight loss medication if appropriate. These medications can be covered by insurance (although not by all insurance plans); it is also possible to find online coupons, discounts, and patient assistance programs.

The Importance of Medical Guidance When Taking Weight Loss Medications

It is important to have regular follow-up appointments to monitor if your weight loss process goes as expected. These are the key reasons:

• Safety and appropriate use: Correct medical advice will help address side effects and adjust the plan as necessary.

• Higher probability of expected results: Under medical supervision, you can discuss the effectiveness of treatment and request changes if needed. This can also prevent misuse of weight loss medications.

• Long-term success: Medication for weight management is stopped at some point, and professional guidance becomes even more important. To see long-term, sustainable results, you’ll have to follow recommendations on diet, physical activity, and other healthy lifestyle choices.

End Note 

If you are considering compounded semaglutide for weight loss, it is essential to weigh the risks and benefits. Consult a healthcare professional to discuss all available options and make an informed decision; everybody is unique, and it’s crucial to identify what can work best for you.

FAQ

Can semaglutide be compounded?

Yes, special pharmacies can compound semaglutide. However, this is usually done when the commercial versions are not available or if the patients require a customized dosage.

Is compounded semaglutide legal?

In the US, compounded semaglutide is legal if it is prepared by specialized pharmacies having compounding licenses as long as they comply with FDA regulations.

Is compounded semaglutide FDA-approved?

Compounded semaglutide is not FDA-approved. This is because the FDA can not regulate compounded drugs as effectively as required. Therefore, compounded semaglutide formulations are not evaluated by the FDA for safety and efficacy.

Do you need a prescription for compounded semaglutide?

Yes, a licensed healthcare provider has to prescribe it to you after an in-person or online consultation, if deemed appropriate.

Is compounded semaglutide the same as Ozempic?

Semaglutide is the active ingredient in both, but they are not equal. Ozempic is an FDA-approved medication (although prescribed for weight loss off-label) while compounded semaglutide is not. Ozempic is produced by pharmaceutical companies while compounded semaglutide is produced by compounding pharmacies, hence its formulation may slightly differ.