Compounded medications can offer a cheaper way to obtain scarce drugs. But the FDA has raised concerns about salt-compounded forms of semaglutide, which may not be safe or effective.

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The drug semaglutide can be used for weight loss, along with diet and exercise, when treating type 2 diabetes. Its use has surged since the Food and Drug Administration (FDA) first approved it in 2021. This has led to a drug shortage and rising prices.

As a result, the idea of using a compounded version of semaglutide that’s mixed with other drugs or different ingredients has become more popular. However, these versions of the drug are not considered safe or effective.

This article will provide more detail about semaglutide and how compounded versions have materialized. It will also explain why the FDA has issued a warning stating that these compounded options may not be safe.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. This means it mimics the GLP-1 hormone, which is released in your digestive tract when you eat. It can prompt your body to make more insulin, which lowers your blood sugar. Semaglutide reduces your appetite by signaling a feeling of fullness in your brain.

This medication is sold in a few forms:

  • Ozempic (injectable): approved in 2017 for lowering blood sugar levels in adults with type 2 diabetes, as well as reducing the risk of heart attack, stroke, or death in those with type 2 diabetes and heart disease
  • Rybelsus (tablet): approved in 2019 as the first and only GLP-1 analog in pill form and indicated to improve blood sugar regulation in adults with type 2 diabetes
  • Wegovy (injectable): approved in 2021 for weight management

Research shows that Wegovy, Ozempic, and Rybelsus can be effective for weight loss.

Use of Rybelsus and Ozempic for weight loss is considered “off-label,” meaning the FDA has not specifically cleared those medications for that use. But doctors can still write a prescription for someone to use one of these medications this way if they feel that it will be safe and effective for that person.

However, to maintain the weight loss benefits of semaglutide, people need to continue taking it. Long-term use of brand-name medication can be costly. This is why a shortage is so concerning to people who rely on this medication and why compounded versions have become more popular.

Compounding involves combining, mixing, or changing the ingredients of two or more drugs to create a new medication.

Sometimes drugs are compounded so people with allergies to certain dyes can take them. It may also be an option for people who need a liquid form of medication instead of a pill form.

Compounding drugs can fulfill an important purpose. When a drug is in shortage, compounders may be able to legally create a compounded version of a drug as long as they meet certain requirements.

Ozempic and Wegovy are both listed on the FDA’s drug shortage list, but the FDA states that people should not use a compounded drug if the approved drug is available.

While there is a long history of compounding drugs to meet specific needs, compounded drugs are not approved by the FDA.

Although there are some restrictions on compounders, the FDA does not verify the safety, quality, or effectiveness of compounded drugs.

Sometimes drugs that are poorly compounded may include too much of the active ingredients. This can lead to serious health complications and even death.

Specifically, the FDA has issued a warning letter about the safety of compounded semaglutide. It mentions reports of compounders using salt forms of semaglutide, even though the FDA has found no valid reason for compounding the drug using these forms.

These salt forms have different active ingredients than the approved medications and have not been shown to be safe or effective.

Potential side effects of semaglutide include:

  • nausea and vomiting
  • diarrhea and constipation
  • stomach pain
  • fatigue
  • hypoglycemia (low blood sugar)
  • acute kidney injury
  • injection-site reactions to injected versions of the drug

Overall, semaglutide is also linked to an increased risk for pancreatitis, pancreatic cancer, thyroid cancer, and gallstones.

And it’s important to remember that when semaglutide is combined with other drugs, additional side effects may occur.

‘I took Ozempic, then got pancreatitis’

Read more here on the personal story of someone who took Ozempic and ended up experiencing pancreatitis as a side effect.

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One of the newest drugs on the market for type 2 diabetes is Mounjaro, a first-in-class injectable medication that was approved in 2022.

Tirzepatide is the active ingredient in Mounjaro. it works by stimulating two hormone receptors in your body instead of just one, as semaglutide does.

Both tirzepatide and semaglutide mimic the hormone GLP-1, but tirzepatide also mimics another hormone, glucose-dependent insulinotropic polypeptide (GIP), and this may further contribute to weight loss.

However, the FDA has not yet approved tirzepatide for weight loss, while semaglutide in the form of Wegovy is approved for weight loss.

Semaglutide is a drug that can be used for weight loss and management of type 2 diabetes. A shortage of semaglutide and rising costs have left many people wondering whether a compounded version is a safe way to access this drug.

The FDA has warned against the use of compounded semaglutide options. If your doctor believes that you would benefit from taking semaglutide, it’s important to discuss with them the safest way to get it and what alternative medications they might suggest.