949.945.0025 Appointment

Is Compounded Semaglutide Safe to Use?

Published by Dr. Brandon Richland, MD

Compounding medication is used to create a unique treatment to address specific individual needs of patients. One example of a compounded drug is compounded semaglutide, which is often composed of semaglutide and cyanocobalamin. The use of compounded semaglutide can lead to unknown reactions, this is the big problem from not being an approved medication.

Key Takeaways of Compounded Semaglutide

  • Compounding is the process of combining, mixing, or altering drugs to create a medication specific to an individual’s needs.
  • Despite its potential benefits, compounded semaglutide should be avoided as it hasn’t been approved by the FDA, and lacks the necessary quality control measures.
  • Patients considering using compounded semaglutide should seek medical advice beforehand to understand the potential risks associated with the drug.
  • Most doctors advise against this form of medication due to patient safety concerns and unregulated distribution.

What is Semaglutide?

Semaglutide is a GLP 1 receptor agonist that helps lower blood glucose levels, and is used for treatment of type 2 diabetes. Is the generic term for main brands Wegovy and Ozempic. Similar medication to semaglutide is Tirzepatide, which is the generic term for pharmaceutical brand name Mounjaro.

It is also known as an effective medication for weight loss in obese or overweight patients by helping regulate metabolism and reduce blood sugar levels to improve digestion and appetite control.

Uses & Dosage of Semaglutide

Semaglutide medication for weight loss mimics the GLP 1 hormone to reduce hunger by signaling a feeling of fullness within the brain. It is often taken subcutaneously once a day in combination with lifestyle changes such as regular exercise and dieting.

Patients with type 2 diabetes who use semaglutide for diabetes treatment. find success in managing their conditions when using semaglutide properly. Their usual dosage is 0.5 mg once weekly via injection or depending on their doctor’s prescription instructions.

What is Compounding?

Compounding is the process of combining, mixing, or altering ingredients to create a new type of medication. It involves modifying the ingredients of two or more drugs and then combining them together based on the patient’s specific conditions or requirements.

Compounding is also used to reformulate a commercially available drug by adjusting its dosage forms, flavors, and potencies that may make it easier for patients to take. It is often used if there is no safe alternative available.

Can Semaglutide be Compounded?

Compounded versions of semaglutide are available for purchase, but these are not officially approved by the FDA.

Image Credit: Sherryyates / 123RF.com (Licensed).

Relevance of Compounded Semaglutide

The FDA has received reports of adverse events after patients used compounded semaglutide, and subsequently warns against using such products. There is no reliable assurance that compounds actually contain the same active ingredient as approved drugs or are safe for human use due to a lack of testing and FDA approval.

This means that individuals may inadvertently be exposing themselves to unknown harmful effects, by taking this drug without fully understanding the dangers associated with it.

Potential Concerns With Compounded Semaglutide

The FDA warns that there is no basis for compounding the drug using the available semaglutide salts and that its bioavailability may be reduced due to destruction during compounding.

Compounded medications are produced without quality control measures such as those used when manufacturing an FDA approved drug, creating a risk of contamination which could endanger a patient’s health if not inspected properly.

Patient Information on Compounded Semaglutide

Patients considering the use of compounded semaglutide should fully educate themselves by talking to their healthcare provider about the safety and efficacy of this form of medication before any use.

Important Things Patients Should Know

Women should be aware that compounds of semaglutide are not considered safe, nor are they as effective as FDA approved products. Note that some compounded versions of semaglutide may contain ingredients or lack active ingredients that could lead to serious side effects or unexpected reactions.

The FDA has raised concerns about unanticipated side effects in people who use such forms of compounded medicines for health reasons.

If unexpected symptoms develop while taking any form of compounded semaglutide, patients should immediately seek help from medical professionals and report all relevant information to the Food and Drug Administration (FDA).

Safety Considerations for Patients

Compounded semaglutide is custom made, meaning it doesn’t undergo the same rigorous testing process as commercially available formulations. Its safety and efficacy are far from established.

Some compounding pharmacies may also utilize salt forms of the drug which lack approval for use in humans or animals respectively due to feared safety issues. Seeking professional medical advice from a qualified healthcare provider, prior to commencing treatment is strongly recommended when looking at compounds for semaglutide or other medications.

It has not been tested or approved by the FDA and could lead to serious health consequences if used improperly. Healthcare providers should advise their patients to avoid any products marketed as compounded semaglutide or generic semaglutide as these are not approved medications per federal requirements.

Reporting Issues to the FDA

Patients should report any issues or concerns related to compounded semaglutide directly to the FDA. As a regulatory agency, the role of the FDA is to protect public health by ensuring the safety and efficacy of all drugs available in the market.

With cases of compounded semaglutide products possibly containing different active ingredients or concentrations than those approved, patients must be aware of potential risks associated with these products, and bring their safety concerns directly to government authorities like the FDA.

Women in particular should be constantly on the lookout for adverse effects, as research suggests changes in hormone levels could impact drug absorption causing interactions involving flavored medications such as this one.

Testing and Approval of Compounded Semaglutide

FDA requires compounded medications to go through a regulatory approval process to ensure public safety and adherence to the highest quality standards.

Image Credit: Filistimlyanin / 123RF.com (Licensed).

Regulatory Processes for Compounded Medications

Compounded versions of semaglutide marketed as injections have not undergone any testing nor been approved by the FDA and therefore make them unavailable for marketing as an approved drug. This means that the compounded version of semaglutide has not gone through a rigorous process, regarding safety and efficacy standards normally required from medications prescribed to patients.

This can lead to potential risks such as decreased potency or bioavailability and side effects related to the inappropriate combination and proportions of active ingredients that were used in compounding these medicines.

Ensuring the Safety and Efficacy of Compounded Semaglutide

To ensure the safety and efficacy of compounded semaglutide, healthcare providers and compounding pharmacies must abide by FDA regulations and guidelines. The FDA approves drugs for safety, quality, potency, and bioequivalence to ensure a product’s effectiveness in reaching its intended target or disease state.

Compounded semaglutide products containing salt based or compounded forms of semaglutide, such as semaglutide sodium and semaglutide acetate have not been approved or evaluated by the FDA due to concerns about their safety and effectiveness compared with branded versions of the drug like Ozempic or Wegovy.

All reports on adverse events associated with compounded drugs should be reported promptly to MedWatch, which is the FDA Safety Information program so they can investigate further if necessary.

Risks and Unauthorized Sources of Compounded Semaglutide

Patients must be aware of unauthorized sources that could sell potentially unsafe products, counterfeit or ineffective compounded semaglutide products.

Potential Risks of Compounded Versions of Semaglutide

The danger of using compounded semaglutide must be taken seriously as it possesses many potential risks. The FDA has not approved this medication and has warned against its use due to the risk of high blood pressure, heart attacks, and strokes.

High levels of sodium may put individuals at risk as this salt is not always monitored by pharmacy compounding. The source of compounded semaglutide sodium is often unknown, which puts patient safety in jeopardy since the quality cannot be ensured or regulated.

Serious health issues such as pancreatitis, thyroid cancer, pancreas cancer, and gallstones have also been associated with both compounded and FDA approved versions of semaglutide.

For patients interested in taking any form of semaglutide, consult with a doctor who can offer recommendations based on individual medical history before beginning treatment, especially when first purchasing prescription medicine online or through online pharmacy.

Unauthorized Distribution and Sources

Only obtain semaglutide products from an FDA approved source. Regulators have raised concerns about pharmacies offering unauthorized alternatives to the medication, as these non FDA approved semaglutide products may not contain the same active ingredient or provide expected benefits.

The FDA warns against turning to compounding pharmacies for generic versions of semaglutide compounds due to potential safety risks such as improper quality control and sterility assurance issues during their creation process.

The Bottom Line on Compounded Semaglutide

Compounded semaglutide poses potential risks, and patients and healthcare professionals must be aware of the differences between this medication and its brand name counterparts.

Recommendations for Patients and Healthcare Professionals

Healthcare professionals prescribing or administering compounded semaglutide have an important responsibility in monitoring patient safety following therapy with this medication, ensuring accurate prescriptions are given and keeping up to date on relevant research surrounding compounding practices.

Compounded semaglutide may have the same effect as its branded counterparts. Patients should be aware of the associated potential risks due to the lack of data available about its use.

Is highly recommended to use proper semaglutide or tirzepatide, and use the recognizable brands like Wegovy, Ozempic or Mounjaro. Contact an experienced doctor, this will make sure you are using the correct and safe semaglutide medication.

Frequently Asked Questions About Compounded Semaglutide

1. How Does Compounded Semaglutide Work?

Compounded semaglutide works by mimicking the hormones released by the body’s beta cells to reduce blood sugar levels after meals and help regulate appetite. It can help manage type 2 diabetes symptoms more effectively over time, especially when taken regularly along with lifestyle changes such as proper diet and exercise.

2. Who Should Take Compounded Drugs?

It’s not recommended to use compounded semaglutide. It’s better to use approved brands like Wegovy, Ozempic, Mounjaro (tirzepatide). This medication has to be under the supervision of a physician as dosage may vary based on individual needs or conditions related to their diabetes management plan or for the weight loss treatment.

Patients taking any other medication or supplement alongside this drug should consult with medical personnel before use. Due to possible side effects like nausea, vomiting, diarrhea and dizziness or other more serious reactions.

Image Credit: Nenetus / 123RF.com (Licensed).

Conclusion and Summary for Is Compounded Semaglutide Safe to Use?

Compounded semaglutide is a medication that has not been approved by the FDA for safe use. Patients should know that this compounded drug doesn’t have the same safety parameters, efficacy, and regulatory standards compared to branded medications such as Ozempic and Wegovy.

Do not use any kind of compounded medication. If you are thinking of using semaglutide, stick to big, recognizable and approved FDA brands, such as Wegovy, Ozempic, Mounjaro or Tirzepatide. Compounded semaglutide can bring unexpected risks to your health.

Please note that this article is intended for informational purposes only and should not be construed as medical advice. Before making any changes to your treatments, please consult with your healthcare provider to discuss the appropriateness and safety of such changes.

Ready For Your First-Class Cosmetic Experience in Orange County (OC) California (CA)?

Are you located in one of these Orange County (OC) / Southern California cities?

Aliso Viejo, Anaheim, Brea, Buena Park, Costa Mesa, Coto de Caza, Cypress, Dana Point, Fountain Valley, Fullerton, Garden Grove, Huntington Beach, Irvine, La Habra, La Palma, Laguna Beach, Laguna Hills, Laguna Niguel, Laguna Woods, Ladera Ranch, Lake Forest, Los Alamitos, Mission Viejo, Newport Beach, Orange, Placentia, Rancho Santa Margarita, San Clemente, San Juan Capistrano, Santa Ana, Seal Beach, Stanton, Tustin, Villa Park, Westminster, or Yorba Linda?

Plastic Surgeon Dr. Brandon Richland, MD and our Cosmetic Aesthetics Team are ready to help you look and feel your absolute best.

Elevate your confidence and self esteem levels to unfathomable new heights!

Schedule your in-person consultation in our modern and luxurious offices in either Fountain Valley, CA (Main HQ) or our Newport Beach, CA office. 

Do you live outside of Southern California or short on time? For your convenience, Virtual Consultations are also available.

Our warm and engaging Team of carefully selected Aesthetics Professionals will make you feel calm, cool, collected, and right at home throughout your entire consultation and surgery process.

Schedule Your Aesthetics Consultation here, or call us directly at 714-241-0646 or 949-945-0025 today.

About the Author

Dr. Brandon Richland, MD is a respected Board Certified Licensed Plastic Surgeon in Orange County / Southern California specializing in cosmetic and reconstructive surgeries.

Driven by his passion for medicine, Dr. Richland obtained his Doctor of Medicine (M.D.) degree from the prestigious program at Saint Louis University (SLU) School of Medicine in 2013. His exceptional skills were recognized when he received the McGraw Hill / Lange Medical Student Academic Achievement Award, and graduated top of his class with Honors. For his undergraduate degree, he attended University of California, Los Angeles (UCLA) and graduated with Honors in 2009.

To further enhance his surgical expertise, Dr. Richland completed his Residency in Plastic Surgery at the University of California, Irvine (UCI) from 2013 to 2019 earning the Academic Achievement Award twice during this period. A total of 14 years in dedicated schooling and medical residency.

Dr. Richland is actively involved with healthcare and medical societies, as a Diplomate of the American Board of Plastic Surgery, a member of the American Society of Plastic Surgeons, American Society of Aesthetic Plastic Surgeons, and the California Society of Plastic Surgeons.

Contact Dr. Richland today by visiting RichlandMD.com, scheduling a cosmetic consultation, or by calling 714-241-0646 or 949-945-0025 directly.