Compounded semaglutide: Is it safe?

Semaglutide is a drug that belongs to a class of medications called glucagon-like peptide-1 (GLP-1) receptor agonists. These drugs mimic the GLP-1 hormone that the gut releases in response to food.

As a 2019 review explains, GLP-1 has numerous functions, including:

• stimulating the pancreas to secrete more insulin, which reduces blood sugar levels
• delaying the time it takes for food to empty out of the stomach
• promoting satiety (fullness) and reducing appetite

The FDA currently approves the following three semaglutide products:

• Rybelsus tablets and Ozempic injections: Doctors may prescribe either of these drugs to lower blood sugar levels in adults with type 2 diabetes who are also following an appropriate diet and exercise program. Ozempic can also reduce the risk of heart attacks and stroke in adults with type 2 diabetes and heart disease.
• Wegovy injection: Doctors may prescribe Wegovy to help treat overweight and obesity in adults and children over 12 years of age who have weight-related medical problems. It can help with weight loss and weight maintenance in individuals who are also following an appropriate diet and exercise program.

Compounded semaglutide is semaglutide that has been through a process called compounding, in which a person alters the drug’s ingredients or combines it with one or more other drugs.

The person who compounds the drug may be a licensed pharmacist or doctor or someone working under the supervision of a licensed pharmacist.

Pharmacists may compound a drug for an individual who cannot take the FDA-approved version of the drug because of an allergy to one of its ingredients or an inability to swallow tablets or capsules.

While the FDA recognizes that compounded drugs fulfill an important medical need for certain individuals, these drugs are not FDA-approved.

This means that the FDA does not verify their quality, safety, or effectiveness before they reach the market.

Semaglutide drugs may have various risks or side effects.

Semaglutide may cause mild side effects, such as:

Semaglutide can also cause more serious side effects. For example, this drug may cause hypoglycemia, where a person’s blood sugar levels drop too low. Without immediate treatment, this condition can be life threatening.

Possible symptoms of hypoglycemia to be aware of include:

• a rapid heartbeat
• shaking
• sweating
• dizziness or lightheadedness
• nervousness or anxiety
• irritability
• confusion

Some other potential side effects of semaglutide that require immediate medical attention include:

• persistent pain beginning in the upper left or middle of the abdomen, which may spread to the back
• skin rashes or hives
• swelling of the following areas:
  • face, mouth, tongue, or throat
  • legs, ankles, or feet
• difficulty breathing or swallowing
• decreased urination
• vision changes
• headache
• slurred speech
• shakiness or jitteriness
• weakness
• mood changes
• drowsiness

Compared with FDA-approved semaglutide, compounded semaglutide poses more risks. This is because compounded drugs may:

• become exposed to contaminants during the compounding process
• contain excess amounts of the active ingredient
• contain traces of other ingredients

The FDA notes that compounded products that are contaminated or have too much of the active ingredient can cause harm or even death. However, compounded semaglutide is considered a safe medication overall.

• metformin
• dipeptidyl peptidase 4 inhibitors
• sodium-glucose cotransporter 2 inhibitors
• sulfonylureas
• thiazolidinediones
• GLP1/GIP agent (tirzepatide)

It is best to contact a healthcare professional if a person with diabetes is finding it difficult to manage their blood sugar levels.

People can also talk with a doctor about their current diabetes treatment plan and other available treatment options.

The FDA does not regulate compounded drugs and cannot verify their safety.

Wegovy is one of three semaglutide products. Because the FDA does not regulate the safety or effectiveness of compounded semaglutide, there is no way to know if it is as effective as FDA-approved semaglutide.

Semaglutide is an FDA-approved drug that healthcare professionals may prescribe to help control blood sugar levels in adults with type 2 diabetes. People also use it to treat overweight and obesity.

Compounded semaglutide is semaglutide a person has chemically altered or mixed with one or more other drugs. Pharmacists may do this for people who cannot take the FDA-approved version of a drug. The FDA does not approve compounded drugs, as it cannot verify their safety or effectiveness.

Semaglutide may increase the risk of hypoglycemia and may cause side effects such as abdominal pain, heartburn, and nausea. Serious side effects to watch out for include a rapid heartbeat, shaking, and sweating. Compounded semaglutide poses additional risks due to the risk of contamination or excess amounts of the active ingredient.

It is best for a person who is having difficulty managing their blood sugar to speak with a doctor.