You’ve likely heard of Ozempic, a type 2 diabetes drug that skyrocketed in popularity for its off-label use for weight loss. However, the potential dangers of the controversial drug often go unreported. If you’re considering Ozempic for weight loss, here’s what you should know.
Established Link Between Ozempic and Gallbladder Issues
According to the FDA, semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists, which mimic the GLP-1 hormone 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). GLP-1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness.
Recently, there has been an established link between GLP-1 receptor antagonists (Ozempic and Wegovy) and cholelithiasis, also known as gallstones. In placebo-controlled trials, cholelithiasis was reported in 1.5% of patients treated with Ozempic 0.5 mg and 0.4% treated with Ozempic 1 mg. Cholelithiasis was not reported in placebo-treated patients.
Ozempic Raises Risk of Acute Gallbladder Disease and Inflammation
Clinical trials, including that of Novo Nordisk, showed that Ozempic could double the risk of acute gallbladder disease in its users. In the trials, 1.6% of semaglutide patients developed gallstones, compared to 0.7% of placebo patients. In addition, gallbladder inflammation was noted in 0.6% of semaglutide patients compared to 0.2% of placebo patients.
Since 2016, multiple scientific journals have established a connection between Ozempic and acute gallbladder disease, gallstones, and inflammation. If you are taking or planning to take Ozempic for type 2 diabetes or weight loss, discuss its potential risks with your doctor to determine if the medication is right for you.
FDA Warns About Ozempic Compounding Risks
Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to an individual patient’s needs. When there is a drug shortage, compounders may be able to make a compounded version if it meets certain requirements in the Food, Drug and Cosmetic (FD&C) Act. Compounded drugs are not FDA-approved, and the FDA cannot verify their safety or effectiveness.
As of May 2023, Ozempic and its sister drug Wegovy are on the FDA’s Drug Shortages List. Compounded semaglutide and semaglutide salts (another form of semaglutide made by compounders) are not reviewed by the FDA for safety, effectiveness, or quality, and the FDA has received adverse event reports after patients used compounded semaglutide.
Is Off-Label Ozempic Use for Weight Loss Dangerous?
Using Ozempic for weight loss can be very dangerous. Ozempic is only intended and approved by the FDA for patients with type 2 diabetes. Unfortunately, due to the immense popularity of the drug for weight loss, it has become harder to obtain for those who depend on it to regulate their blood sugar levels.
Other potentially dangerous side effects of off-label Ozempic use include:
- Allergic reactions
- Hypoglycemia (low blood sugar)
- Diabetic retinopathy (damage to blood vessels in the eye)
- Kidney failure and other kidney problems
- Increased thyroid cancer risk
- Gallstones
- Swelling of the pancreas
Is Ozempic Safe to Take During Pregnancy?
While data from pregnant rodents, rabbits, and monkeys exposed to semaglutide showed structural abnormalities in fetuses and early pregnancy losses, there’s not enough information available at this time to ensure that Ozempic is safe to take during pregnancy.
According to the prescribing information for Ozempic and Wegovy, users should stop taking Ozempic two months before they plan to conceive to ensure that the semaglutide is out of their system during pregnancy. In addition, users should avoid Ozempic while breastfeeding to avoid exposing their infant to semaglutide through nursing.
Ozempic Lawsuit Lawyers Protecting the Good People of The Carolinas
While Ozempic continues to surge in popularity, it is crucial that you stay aware of the many health risks associated with its off-label use. If you have used Ozempic and are experiencing gallbladder issues or other health complications, contact your doctor immediately. The Ozempic lawsuit attorneys at Grimes Teich Anderson are closely monitoring reports of Ozempic’s adverse health effects and are ready to review your case for free. You may be eligible for compensation.
Contact us today by submitting a form below or calling our office at 800-533-6845 for a free case evaluation.