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.
Negative Side Effects
While undoubtedly effective, semaglutide drugs have significant adverse side effects. Ozempic details its most common serious side effects on the drug’s warning label. Currently, listed side effects include:
- inflammation of your pancreas (pancreatitis). Stop using Ozempic® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Ozempic®.
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Ozempic® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or Iightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
- kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
- serious allergic reactions. Stop using Ozempic® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
- gallbladder problems. Gallbladder problems have happened in some people who take Ozempic®. Tell your healthcare provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.
The most common side effects of Ozempic® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation, according to the Ozempic warning label.
Over 10,000 semaglutide-related adverse events were reported to the FDA’s Adverse Event Reporting System (FAERS) — a database that contains adverse event reports, medication error reports, and product quality complaints submitted to the FDA — through the 4th quarter of 2021. Semaglutide products were identified as suspect products for gallbladder-related disorders in these reports, finding 7,538 adverse reports for Ozempic; 1,223 for Rybelsus, and 564 for Wegovy.
Gallbladder Warning
The Ozempic label currently warns that acute gallbladder disease and Thyroid C-cell tumors can occur. However, until March 2022, the Ozempic warning label did not adequately warn patients or doctors about the risk of gallbladder disease despite evidence arising that patients experienced such complications.
A series of published scientific studies and reports concluded that acute cholecystitis (gallbladder disease) and cholelithiasis (gallstones) was associated with therapy of GLP-1 receptors and drugs. In other words, Ozempic’s chemical makeup put users at higher risk of gallbladder related diseases, while the label issued no warning before March 2022 (Green Matters).
In one of these studies, Daniel Woronow, MD, and colleagues from the FDA in Silver Spring, Maryland, found that 36 patients taking semaglutide between 2005 and 2016 developed acute gallbladder disease, three of whom died. In 42 percent of those cases, the gallbladder problems started within 90 days of first taking Ozempic. Novo Nordisk added warning labels about gallbladder complications to the drug in March 2022.
Law firms are now investigating cases of patients who developed gallbladder problems after taking the drug. The legal issue is whether Novo Nordisk knew or should have known about the serious health risks Ozempic poses to users of their drug and neglected to properly warn doctors and patients of this risk.
Individuals who used Ozempic prior to the updated warning label, including the gallbladder risks, and who developed gallbladder disease, gallstones, or had their gallbladder surgically removed may be able to pursue a product liability lawsuit and receive financial compensation.
Projectile Vomiting
Ozempic’s warning label advises users to stop using the drug if they experience stomach pain, sometimes accompanied by vomiting. Nausea is the most common side effect, and up to 20% of people taking it for Type 2 diabetes reported nausea in clinical trials, according to GoodRx Health.
Nausea and vomiting are more likely with the higher doses of semaglutide. This is why the semaglutide dosage, whether in the form of Ozempic or Wegovy, is slowly increased over several weeks. While Ozempic says this is normal, vomiting accompanied by severe stomach pain could be severe enough to require kidney function monitoring due to the risk of dehydration (Good Rx Health). Interestingly, the Rybelsus label advises physicians to monitor kidney function in patients who experience serious vomiting.
Ozempic users experiencing this uncomfortable side effect have taken to Reddit discussion groups, hoping to find out if others are having similar problems. One user submitted her inability to control the vomiting after starting Ozempic. She wrote: “I had a green juice, and the green juice came out in the form of projectile vomiting…It was so bad that my sister thought I was choking on my own vomit…I just ended up vomiting all over myself and feeling really shakey.”
The discussion forum was flooded with relatable experiences and pieces of advice. One user responded with: “This happened to me, I was taking .25 and would projectile vomit every day.” Another replied: “I now keep barf bags in my car.”
Ozempic Face
In addition to the internal side effects of Ozempic, users who take the drug for its cosmetic benefits are finding the slimming drug is doing its job a little too well. Unflattering effects have triggered the popular buzzword: Ozempic face.
Some users experience a gaunt, aged appearance in the face. Dr. Oren Tepper, a plastic surgeon in New York who was quoted in an Ozempic New York Times article, stated that when it comes to facial aging, fat is usually key to a more youthful appearance. “Ozempic face” is a hollowed, sagging, and more wrinkled appearance thanks to Ozempic’s ability to shave weight from everywhere.
Not only have Ozempic users experienced less flattering facial appearances, but “Ozempic Butt” and “Ozempic Fingers” have earned buzzword status as well. Fat loss can occur in the butt, leading to a deflated, flat, and sagging appearance that users don’t typically desire. Users with “Ozempic Fingers” find that their jewelry and rings no longer fit, and their fingers and wrists are more bony than before. The New York Post found that jewelers have reported women sizing down rings and bracelets, up a shocking 150% compared to last year.
Sh*t the Bed Club
An even more unseemly effect of Ozempic, according to the Post, includes waking up with soiled sheets. Some users say they’ve joined a “sh*t the bed club” due to the significant gastrointestinal effects of Ozempic. Semaglutide users congregate on the Reddit discussion forum, trying to sift through what is normal and what might be cause for alarm.
One comment on the discussion thread reads, “Almost shit my pants today RUNNING for the bathroom when my constipation, without warning, decided to identify as WWIII.” According to Insider, about 30% of Wegovy users have suffered from diarrhea, while 24% have experienced constipation.
Suicidal Ideation
On Monday, July 10th, the European Medicines Agency said it would undertake a review into a number of obesity-treating and antidiabetic drugs after it was reported some patients experienced thoughts of suicide or self-harm (CNBC).
The statement made by the EMA said that its safety committee was “currently evaluating the risk of suicidal thoughts and thoughts of self-harm in patients who used a semaglutide — or liraglutide — containing medicine for weight loss.” The call for this evaluation is the result of three case reports: two cases of suicidal thoughts, one following the use of Saxenda (a daily liraglutide antidiabetic), and one following the use of Ozempic. The third case reported thoughts of self-injury with Saxenda.
Interestingly, the current Wegovy label does list suicidal thoughts as a potential adverse reaction. Such a warning is not included in the labels for Ozempic or Rybelsus. According to the New York Post, the EMA has launched an investigation into all of Novo Nordisk’s weight loss treatments, as well as any other medications that contain semaglutide or liraglutide.
Bowel Obstruction
A study published in the monthly journal Acta Pharmaceutica Sinica B found an “increased risk” of intestinal obstruction when taking semaglutide. Researchers showed that the risk of intestinal obstruction when taking semaglutide is 4.5 times higher than when receiving other glucose control medications. The researchers found that drugs mimicking GLP-1 can reduce motility in the gut, leading to constipation and potential intestinal obstruction — a potentially fatal condition that requires surgery (The Edge).
Dangers of a high-cost Weight Loss Drug
Novo Nordisk, the Danish pharmaceutical company that originally developed semaglutide, holds a patent on the antidiabetic. Because of its patent, Novo Nordisk is able to charge whatever it wants, and according to the Institute for Clinical and Economic Review, Novo Nordisk is grossly overcharging.
In an evidence report by the ICER titled Medications for Obesity Treatment: Effectiveness and Value, the nonprofit estimated that a fair price for the drugs, when considering the overarching health benefit, would be 44% to 57% cheaper than what they are currently sold for. In 2022, ICER issued an access and affordability alert for semaglutide in the management of overweight and obesity, signaling stakeholders and policymakers to take action.
Antidiabetic drugs like Ozempic are not covered for obesity, so most health insurance covers it for treating diabetes only. While Wegovy is FDA-approved for treating weight loss, a month’s supply costs about $1,300 out of pocket. Ozempic is about the same. Users might splurge for the initial weight loss but can’t afford to stay on the medication long-term to keep the weight off.
But when people stop taking semaglutide, there’s often a rebound weight gain that becomes even more insurmountable than before. A study published by Diabetes, Obesity and Metabolism found that users regain most of their lost weight within a year of stopping the medication (Wilding et al.)
Either due to the high cost or ongoing shortages, people are seeking alternatives to Ozempic and Wegovy, according to NBC. One way to find these copycat drugs is through compounding pharmacies.
Compounding “is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient,” the FDA says. “Compounding includes the combining of two or more drugs.” So, pharmacies known to carry and distribute these copycat drugs are called compounding pharmacies.
“When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act,” the FDA says, but the agency doesn’t review these compounded versions for safety, effectiveness or quality. So, while semaglutide may be approved by the FDA, a compounded version of it does not undergo the same monitoring or testing.
According to an article published by NBC Health News, physicians don’t know where compound pharmacies are getting information on semaglutide. Novo Nordisk, the patent holder and sole distributor of Ozempic and Wegovy, said in a statement that it does not provide the ingredients to pharmacies, and compound semaglutide might not be semaglutide at all.
Pharmacies aren’t always transparent about how they’ve created or sourced a drug, according to Dr. Chris McGowan, an owner of a weight loss clinic and a source for the NBC article. Further, it’s possible semaglutide sodium is being sold, a cheaper and modified version of the compound intended for research only. Semaglutide sodium, however, isn’t approved by the FDA, and the sale of it would be wholly illegal (NBC).
The FDA says that it has received reports of adverse events in people who used compounded semaglutide and that patients “should not use a compounded drug if an approved drug is available.”
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.
On the Horizon
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 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.