Left Chevron
Back
Left Chevron
Reporting a Medication Error

Staying Safe When Using New Medications for Obesity

Published March 31, 2023

Many people want to lose weight as quickly as possible. As a result, new diets to lose weight are always popular. Often, you must follow special instructions such as what you can or cannot eat. You may need to purchase products such as pre-packaged food, protein bars, and powdered shakes. Recently, through the power of social media and studies that show positive results in losing weight, a new treatment has gained public attention. There are no shakes to drink or foods you cannot eat. It just takes injecting a prescription medicine called semaglutide under the skin. Semaglutide works by decreasing your appetite, so you eat less.

Figure 1 (left). FDA-approved Ozempic prefilled syringe is for treating type 2 diabetes. Figure 2 (right). FDA-approved Wegovy prefilled syringe is for treating obesity and other weight-related medical problems.

That all sounds easy. However, if you are thinking about using semaglutide to lose weight, it is important to know the following.

First, semaglutide is a prescription medicine used to treat type 2 diabetes. It helps the insulin in your body lower blood sugar levels. Semaglutide, known by the brand name Ozempic, was approved to treat type 2 diabetes by the US Food and Drug Administration (FDA) in 2017 (Figure 1). It comes in a prefilled pen device that you must inject once every week.

Figure 3. Example of a website sale price with a one-month supply below the price of the FDA-approved product.

A side effect of semaglutide is weight loss. So, the manufacturer did studies using semaglutide at a higher dose to treat obesity. The new, higher-dosed product, given the brand name Wegovy, was FDA approved in June 2021 to treat obesity or other weight-related medical problems (Figure 2).

Soon, people started talking on social media about how you can lose weight by using semaglutide. Even some celebrities talked about it, and semaglutide soon became known as “the hottest drug in Hollywood.” Prescriptions for Wegovy increased even with its high cost (about $1,350 for a month’s supply), which often was not covered by insurance.1-2 Ozempic, for diabetes, is about half the price of Wegovy.3 So, doctors began prescribing Ozempic off-label for weight loss. An off-label prescription is when a doctor legally prescribes an approved medicine for an unapproved use. Since the need for both drugs is so high, the manufacturer has not been able to make enough. By December 2022, many pharmacies could not obtain either medicine to fill prescriptions. Even patients who needed semaglutide to treat their diabetes could not get it. Both prescription medicines were put on the FDA drug shortage list.

Figure 4. Example of a website letting a customer purchase semaglutide without a prescription.

Some people who were not able to fill their prescriptions at their local pharmacies found another way to get the medicine – compounding pharmacies. If a medicine is on the FDA drug shortage list, a compounding pharmacy may make the medicine from raw ingredients, from an FDA-registered and inspected manufacturer. But how they get the ingredients is sometimes in question. Novo Nordisk, the manufacturer of Ozempic and Wegovy, has exclusive rights to semaglutide. Novo Nordisk confirmed it does not provide the raw ingredients to compounding pharmacies. So, they are unsure how compounding pharmacies make the medicine. It could be from a different form of semaglutide such as semaglutide sodium. Or they may start with Ozempic or Wegovy and prepare a different strength.

The availability and use of semaglutide has increased quickly. There are many online websites where you can buy semaglutide. It is an easy way for consumers to get the medicine and the price is much less than the FDA-approved products (Figure 3). Consumers, however, should be aware that compounded drug products can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product.  However, compounded drug products such as semaglutide, pose a higher risk to patients than FDA-approved drug products because compounded drug products do not undergo FDA safety checks.  Compounded drug products should only be used when the needs of patients cannot be met by an FDA-approved drug product.

Websites that sell semaglutide for weight loss often call themselves weight loss spas and weight loss clinics. They do not require a prescription (Figure 4) or may say that you can get a “prescription” from their online physician (at an additional cost). Some websites are also advertising a “youth program” for children ages 12 and older (Figure 5).

Figure 5. An example of a website for youth.

Because the manufacturer has not authorized anyone to duplicate their product, it is unknown how safe other sources of semaglutide are. Many of the websites state they are getting the medicine from a compounder, but it is not known which compounder provides them. Therefore, there is no guarantee the medicine is what it claims to be.

Here's what you can do:

  • Do NOT use semaglutide without being followed closely by the doctor who prescribed the medicine for you. This includes having regular visits (i.e., every 3 months).
  • The medicine is for obesity, which a doctor needs to diagnose. It should not be used to lose just a few pounds.
  • There are certain conditions where semaglutide should not be used, including decreased kidney function and acute inflammation of the pancreas.
  • You must be monitored by your doctor to make sure that serious side effects do not occur. For example, semaglutide can cause problems with your pancreas, kidneys, and gallbladder. Other side effects include low blood sugar, dizziness, fast heartbeat, sweating, mood changes, and more.
  • Semaglutide products from compounding pharmacies cannot be guaranteed as safe and may not even be located in the United States.
  • Semaglutide, manufactured by Novo Nordisk, is only available in a pen for self-injection. Never use semaglutide from a vial, where you need to prepare doses using a syringe and needle to inject.
  • Wegovy is the only semaglutide medicine FDA approved for weight loss. Be sure the brand name Wegovy is on the prefilled pen.
  • Semaglutide is only FDA approved for people ages 12 and older. It is not known if it is safe for children younger than 12.

     References:             

  1. NovoNordisk Forecasts Record Profit Fueled by Obesity Drug -Bloomberg  
  2. What Does Wegovy® Cost? | NovoCare®   
  3. Ozempic® Cost | NovoCare®

More Safety Articles