The Semaglutides — What are they?
Semaglutide is a compound belonging to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. The body’s GLP-1 hormone is released in the gastrointestinal tract in response to eating. One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar). The compound semaglutide mimics the body’s own GLP-1 hormone, proving itself a powerful tool in treating Type 2 Diabetes (UCLA Health).
According to the Food and Drug Administration, in higher amounts, GLP-1 reacts with the parts of the brain that reduce appetite and can signal a feeling of fullness. Semaglutide’s ability to produce insulin and reduce blood sugar made the compound a desirable Type 2 diabetic treatment option. However, given its appetite-suppressant qualities, semaglutide attracted an alternative audience seeking a different treatment goal — weight loss.
The Danish pharmaceutical company Novo Nordisk invented and developed the semaglutide compound and has since released three drugs sold under the names Ozempic, Wegovy, and Rybelsus. Semaglutide is the active agent in each drug. While the compound was originally approved only as an antidiabetic medication, patients have flocked to their weight loss properties (NYTimes).
Ozempic and Wegovy are under-the-skin drugs, meant to be injected once a week in the stomach, thigh or arm through a pen-like instrument. The FDA approved Ozempic in 2017 only to lower blood sugar levels in adults with Type 2 diabetes, but it is now commonly prescribed for the off-label use of weight loss. Wegovy, on the other hand, was approved by the agency in 2021 to treat adults for weight loss (FDA).
For Ozempic, the beginning dose is 0.25 mg once a week for the first 4 weeks. According to the Ozempic website, this gives the body a chance to acclimate to the medicine. At Week 5, the dose is increased to 0.5 mg once a week.
The injection method for Wegovy is similar. Wegovy comes in 5 different dosages. Users start Wegovy at a dose of 0.25 mg once a week and increase the dose every 4 weeks until they reach the full dose of 2.4 mg. Each dose comes in a different color pen and is injected at the same body sites as Ozempic. Wegovy is also used for chronic weight management in pediatric patients aged 12 and older.
Rybelsus, approved in 2019, serves the same function as Ozempic, but is offered in daily oral tablet form to be taken thirty minutes before eating. This oral medication provides a convenient alternative to injectable options. Users will usually take 3 mg once a day for the first month, after which the dose will be raised to 7 mg once a day. After the first month, a healthcare provider would decide whether a dosage increase to 14 mg is beneficial (Health Line).
Oral medications like Rybelsus offer a daily pill option, while Ozempic and Wegovy are once-weekly injections.
FDA Approved Regulation
Semaglutide products are soaring in popularity. Of the three FDA approved semaglutides, only Wegovy is currently approved for weight loss.
Ozempic injection is approved to lower blood sugar levels in adults with Type 2 Diabetes when paired with diet and exercise. It is also approved to reduce the risk of heart attack, stroke, or death in adults with Type 2 Diabetes and known heart disease. The FDA has not approved Ozempic as a weight loss drug.
Despite not having approval for weight loss, Ozempic sales have soared for those looking to lose weight. While Ozempic isn’t an over-the-counter drug, patients have been readily able to obtain off-label prescriptions for Ozempic from healthcare professionals. It is important to obtain prescription drugs from state-licensed pharmacies within the U.S. to ensure the quality and safety of drug manufacturing, packaging, distribution, and labeling.
Unlike Ozempic, Wegovy is specifically approved by the FDA for weight loss. In 2021, the agency approved the drug to help adults and children aged 12 years and older with obesity. The drug is also meant to assist overweight adults who also have weight-related conditions, such as high blood pressure, high cholesterol, or Type 2 diabetes, to lose weight. The drug is to be paired alongside reduced calorie diet and increased exercise.
Similar to Ozempic, Rybelsus is approved to lower blood sugar levels in adults with Type 2 Diabetes, in addition to diet and exercise. To date, Novo Nordisk has not sought a weight loss indication for Rybelsus. All three semaglutide medications are only available with a prescription, and there are no FDA-approved generic versions (FDA). It is crucial to take only prescribed medications and avoid purchasing from unauthorized sources.
Some Negative Side Effects
Although semaglutide drugs like Ozempic are effective in managing type 2 diabetes and aiding in weight loss, they come with a range of adverse side effects:
- Serious allergic reactions: Symptoms like swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, severe rash or itching, fainting, or rapid heartbeat warrant immediate medical attention.
- Gallbladder problems: Gallbladder issues, such as gallstones, have been reported in some users. Symptoms include upper abdominal pain, fever, jaundice, or clay-colored stools, which should be addressed by a healthcare provider.
- Pancreatitis (inflammation of the pancreas): Users should stop taking Ozempic and contact their healthcare provider immediately if they experience severe, persistent abdominal pain, with or without vomiting. The pain may radiate from the abdomen to the back.
- Vision changes: Any changes in vision during treatment should be reported to a healthcare provider promptly.
- Low blood sugar (hypoglycemia): The risk of low blood sugar is higher when Ozempic is combined with other medications, such as sulfonylureas or insulin. Symptoms of hypoglycemia can include dizziness, blurred vision, irritability, sweating, slurred speech, confusion, and shakiness.
- Kidney problems (kidney failure): Nausea, vomiting, and diarrhea associated with Ozempic can lead to dehydration, which may worsen kidney function, particularly in individuals with pre-existing kidney issues. Staying hydrated is critical to reducing this risk
Additionally, common side effects noted on the Ozempic label include nausea, vomiting, diarrhea, abdominal pain, and constipation.
The FDA’s Adverse Event Reporting System (FAERS) has logged over 10,000 adverse events related to semaglutide through the fourth quarter of 2021. Among these, semaglutide products were frequently associated with gallbladder-related disorders. Specific reports include 7,538 adverse events for Ozempic, 1,223 for Rybelsus, and 564 for Wegovy. These figures underscore the importance of monitoring side effects and discussing any concerns with a healthcare provider while using these medications.
The Risks of a High-Cost Weight Loss Drug
Novo Nordisk, the Danish pharmaceutical company behind semaglutide, holds the patent for this antidiabetic medication, allowing it to set high prices without competition. According to the Institute for Clinical and Economic Review (ICER), these prices are significantly inflated. ICER’s report, Medications for Obesity Treatment: Effectiveness and Value, suggests that a fair price for semaglutide-based drugs, considering their health benefits, would be 44% to 57% less than their current cost. In 2022, ICER issued an affordability alert for semaglutide, urging policymakers and stakeholders to address its unsustainable pricing.
While Ozempic is covered by most health insurance for managing diabetes, it is not typically covered for obesity treatment. Wegovy, a semaglutide medication approved by the FDA for weight loss, costs approximately $1,300 per month out of pocket, with Ozempic priced similarly. For many, the high cost limits long-term use. Those who discontinue the drug often experience rebound weight gain, making it even harder to maintain weight loss. A study in Diabetes, Obesity and Metabolism found that most users regain the weight within a year of stopping the medication.
Due to the high costs and ongoing shortages, people have started exploring alternatives, including compounded versions of semaglutide from compounding pharmacies. Compounding involves combining or altering ingredients to create a medication tailored to an individual patient’s needs. The FDA permits compounding in cases of drug shortages, provided specific requirements under the Federal Food, Drug, and Cosmetic (FD&C) Act are met. However, compounded drugs are not FDA-reviewed for safety, effectiveness, or quality.
This lack of oversight creates significant risks. Physicians and researchers have raised concerns about the sourcing and composition of compounded semaglutide. Novo Nordisk, the sole distributor of Ozempic and Wegovy, has confirmed it does not supply semaglutide ingredients to compounding pharmacies. Some compounded versions may use semaglutide sodium, a cheaper, unapproved compound intended for research purposes only. Semaglutide sodium is neither FDA-approved nor legally sold for medical use.
The FDA has received reports of adverse events associated with compounded semaglutide. Patients using these alternatives may face unknown risks, as compounded versions lack the rigorous testing and safety standards applied to FDA-approved drugs. The FDA advises against using compounded medications when an approved drug is available, emphasizing the potential dangers of these unregulated alternatives.
Growing Popularity
It is not uncommon for health care providers to prescribe medications for “off-label” use, and Ozempic is a clear cut example. “Off-label” use is taking a medication for a different purpose than what it is explicitly intended for. Taking Ozempic for weight loss, when it is approved and intended for treating Type 2 Diabetes, is an example.
The FDA states that when taking a drug for its approved use, you can be sure the agency has conducted a careful evaluation of its benefits and risks for that use, the decision to use the drug is supported by strong scientific data, and there is approved drug labeling for healthcare providers on how to use the drug safely and effectively for that use (FDA).
However, the FDA also states that once it has approved a drug, healthcare providers may prescribe that drug for unapproved uses, if they judge that it is medically appropriate for their patient. This is not an uncommon practice, but as it becomes increasingly available, it also becomes increasingly popular — especially when celebrities and social media promote the practice.
Elon Musk, the tech magnate, was asked in a tweet, “Hey, @elonmusk what’s your secret? You look awesome, fit, ripped & healthy. Lifting weights? Eating healthy?” To which Musk responded “Fasting…And Wegovy”.
At this year’s Academy Awards ceremony, host Jimmy Kimmel joked, “Everybody looks so great. When I look around this room, I can’t help but wonder, ‘Is Ozempic right for me?’” Actress and comedian Chelsea Handler admitted to taking the weight loss drug without fully understanding it. After finding out the drug was intended for Type 2 diabetics, the actress claimed she immediately stopped.
Actress Amy Schumer also admitted to beginning Ozempic but stopped after feeling so sick she couldn’t play with her son. She then criticized other celebrities, without naming any specifics, for denying or not being forthcoming about Ozempic usage. Tik Tok creator and model Remi Bader revealed she took Ozempic after being prescribed by her doctor but claimed she gained double the weight back. Other celebrities such as Julia Fox, Kyle Richards, Mindy Kaling, and others have denied using Ozempic despite allegations to the contrary (Elle).
Semaglutide and its oral counterpart, Rybelsus, are also being used for weight management, showing potential effectiveness compared to injectable options like Wegovy.
Future Inventions
Novo Nordisk is working towards a new oral form of semaglutide, as recently published in their two self-funded studies on July 25, 2023. The first study demonstrated that 50 milligrams of semaglutide, when taken orally each day, is about as effective as the weekly Wegovy shots that reduce weight in overweight or obese people. Wegovy shots contain just 2.4 milligrams of semaglutide. The second study aimed to prove the efficacy of oral semaglutide for people with Type 2 diabetes. Participants were divided into three groups, each given either 14-milligram, 25-milligram, or 50-milligram doses daily by mouth. The higher the dose, the more weight is lost (NYTimes).
However, it also seemed that the higher the dosage, the more side effects were experienced. The study found that adverse events were reported by 404 (76%) participants in the oral semaglutide 14 mg group, 422 (79%) in the 25 mg group, and 428 (80%) in the 50 mg group. Gastrointestinal disorders, which were reported as mostly mild to moderate, occurred more frequently with oral semaglutide 25 mg and 50 mg than with 14 mg (Aroda et al.).
No new safety concerns were revealed, which may lead to the introduction of oral forms of Ozempic and Wegovy. However, an oral semaglutide has already been approved. Rybelsus, as mentioned above, is an FDA approved drug for adults with Type 2 diabetes, but the semaglutide dosage is comparably lower and according to the New York Times, Rybelsus at current doses is less effective than Ozempic and Wegovy for weight loss.
Goza and Honnold Investigating Semaglutides Claims
We are now investigating claims for patients who have been seriously hurt by taking semaglutide medications. Currently, we are evaluating medical malpractice and product liability claims involving the following injuries:
- Kidney injury and acute renal failure due to dehydration from vomiting and diarrhea
- Hiatal hernia and esophageal injury from forceful vomiting
- Gallbladder disease and surgical gallbladder removal prior to the March 2022 label change
- Intestinal obstruction caused by constipation, dehydration, and the delay of food passing through the GI tract
- Suicidal ideations and suicide attempts
- Vision loss, worsening of diabetic eye disease, and macular damage caused by taking semaglutide (especially long-term use)
- Medical malpractice where patients suffer serious injury from semaglutide because the prescribing doctor did not properly inform the patient of the serious potential risks of the drug or take necessary steps when adverse effects developed
Given the widespread prescribing of these medications, especially off-label prescribing for those who are not obese or seriously overweight, patients are being unnecessarily hurt. We look forward to working with you on a referral or co-counsel basis. Please contact us at (913) 451-3433 or fill out a contact form regarding any questions you might have regarding potential semaglutide claims.
Goza & Honnold, a trusted personal injury law firm serving Missouri and Kansas, is known for our dedication to client advocacy and trial excellence. With a strong focus on auto accidents, medical negligence, and product liability cases, our experienced attorneys work diligently to secure fair outcomes while being fully prepared to take cases to trial when necessary. We work closely with our clients to build strong cases that reflect their unique experiences.