Esto es lo que sabemos sobre la seguridad de la semaglutida sublingual

Key Points:

1. Specialized pharmacies create compounded medications tailored to a person's unique needs. In some cases, compounded medicines also help fulfill medications when the brand-name versions are in short supply.
2. While compounded medications are not FDA-approved, the best way to get quality medication is to work with a medical provider who sources prescriptions from a licensed facility.
3. Dr. B works with FDA-registered 503B compounding pharmacy partners who follow strict rules and test their products rigorously. So our patients can trust that the compounded Semaglutide medication they receive is safe and effective.

Dr. B is thrilled to offer patients safe, effective and affordable GLP-1 medications via Shed It—our holistic prescription weight loss program.

Naturally, we expect patients to have questions about how compounded medicines are made and how the sublingual compounded form compares to injectable versions of Semaglutide.

Here's what you need to know about the safety of compounded Semaglutide.

What exactly is a compounded weight loss medication?

Compounded products are made by pharmacists at specialized pharmacies.

Sometimes, pharmacists custom-make compounded medicines as an alternative to standard drug formulas so that they fit a patient’s unique needs.

For example, someone who can't swallow capsules might order a compounded medicine in liquid form. Or a person who is allergic to the dye in a skin cream might have a compounded version made without that ingredient.

At other times, compounded medications are made to address a drug shortage.

In 2022, the US Food and Drug Administration (FDA) added brand-name Semaglutide weight loss injection medications to its drug shortage list. Pharmacies that met certain requirements were permitted to create compounded forms of the same medications to fill those gaps for the patients requiring treatment.

Recently removed from the drug shortage list, the FDA gave those compounding pharmacies a specific timeframe to dispense their remaining injectable Semaglutide medications.

But the sublingual form of Semaglutide is not affected by the drug shortage list. So it can still be prescribed and filled by compounding pharmacies.

Are compounded medications FDA-approved?

Compounded medications are not generics or FDA-approved drugs. That means the FDA does not verify their safety and efficacy in the same way that it approves standard medications.

But in the US, state agencies (and sometimes the FDA) oversee the specialized pharmacies that make compounded medicines. In some cases, compounding pharmacies even source their active ingredients from the same FDA-registered facilities used by drug manufacturers.

While the medications they make are not FDA-approved, licensed compounding pharmacies follow strict safety standards. They also test their products carefully to guarantee their quality, potency, stability and effectiveness.

A licensed provider can help you source medicines from state-licensed pharmacies or outsourcing facilities registered with the FDA and make sure that your compounded prescription treatment is the correct formula and dosage for you.

How does compounded sublingual Semaglutide compare to other prescription medical weight loss options?

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist medication. That means it mimics the GLP-1 hormone made in the body. This hormone helps lower blood sugar levels, slow digestion and promote fullness.

Semaglutide is the active ingredient in brand-name Wegovy®* and Ozempic®* autoinjector pens. (Dr. B also prescribes these medications.)

Compounded sublingual Semaglutide works a bit differently.

• This form is taken sublingually, which means a liquid medication is held under the tongue rather than being injected directly into tissues.
• Sublingual Semaglutide is taken daily, whereas Ozempic® and Wegovy® are administered weekly.
• Before the FDA approved injectable Semaglutide for weight loss, Wegovy® underwent several clinical trials that monitored its safety and efficacy. Because sublingual Semaglutide is a compounded drug, researchers did not include this form in those trials.
• Since sublingually administered Semaglutide has not been tested in clinical settings, we lack equivalent data on its safety and efficacy in patients. However, sublingual medication forms have been safely administered for many years. 

Why are weight-loss medications controversial?

There are a few reasons why compounded medical weight loss medications get a lot of (justified) buzz.

• Because the FDA doesn’t review and approve them, they can vary in quality and effectiveness—especially compared to their brand-name or generic medication versions.
• Weight loss medications are often not covered by health insurance. So they can be expensive to pay for out-of-pocket, especially as they’re prescribed indefinitely to manage a chronic condition.
• Most people tend to regain weight if they stop taking GLP-1 weight loss medicines.
• Losing weight alone does not automatically improve health.
• GLP-1 treatment is prescribed with diet and exercise. But because the medications cause weight loss, not every patient adheres to the guidelines. When this happens, the medication can cause adverse effects like muscle and bone density loss.

A holistic approach to prescription weight loss is the best way to guarantee lasting benefits. By combining effective personalized compounded Semaglutide weight loss medication with nourishing foods and regular movement, you can manage chronic conditions and achieve your health goals.

Can I get sublingual Semaglutide prescribed online? 

Dr. B prescribes compounded sublingual Semaglutide via our holistic prescription weight loss program, Shed It.

If qualified for treatment, patients meet monthly with a certified weight loss (obesity) doctor via chat or video to review their health history, symptoms, goals and treatment progress.

Because we always want our patients to feel completely safe throughout treatment, the monthly Shed It program fee includes unlimited check-ins with a licensed provider and our support team. So if our patients have questions or concerns, they can request a provider callback or chat with a team member at any time.

Learn more about how Shed It works in this Dr. B article or…

Start a Shed It consultation today!

Wegovy® and Ozempic® are registered trademarks of their respective owners. Our use of these names is for informational purposes only and does not imply any affiliation, endorsement or approval by the trademark holders.

Sources:

Lupkin, Sydney. (2024). Compounding pharmacies are making their own versions of blockbuster weight loss drugs. NPR.

US Food and Drug Administration. (2022). Compounding and the FDA: Questions and answers.

US Food and Drug Administration. (2020). Compounding laws and policies.

US Food and Drug Administration. (2024). Medications containing semaglutide marketed for type 2 diabetes or weight loss.