What is the current safety data on Ozempic (semaglutide)?

From the Guidelines

Ozempic (semaglutide) has a generally favorable safety profile based on current data, though it does have some important side effects to be aware of, as reported in the most recent study from 2024 1. The most common side effects include gastrointestinal issues such as nausea, vomiting, diarrhea, and constipation, which typically improve over time as the body adjusts to the medication. More serious but rare concerns include pancreatitis, diabetic retinopathy complications, and potential thyroid C-cell tumors (based on animal studies) as noted in the 2023 study 1. The FDA has also issued warnings about potential risks of intestinal blockage. Recent safety signals being investigated include potential associations with suicidal thoughts and hair loss, though definitive links have not been established. Patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 should not use Ozempic, as stated in the 2023 guideline 1. The medication is typically started at a low dose and titrated upward slowly to minimize gastrointestinal side effects, as recommended in the 2024 review 1. Patients should report severe abdominal pain, persistent vomiting, or signs of allergic reactions immediately to their healthcare provider. The benefits of improved blood sugar control and cardiovascular protection generally outweigh these risks for most patients with type 2 diabetes, as demonstrated in the 2023 study 1.

Some key points to consider when prescribing Ozempic include:

• Starting with a low dose and gradually increasing as needed and tolerated
• Monitoring for signs of pancreatitis, thyroid C-cell tumors, and other rare but serious side effects
• Counseling patients on the potential risks and benefits of the medication
• Encouraging patients to report any adverse effects or concerns promptly
• Considering alternative treatments for patients with a history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. It's also important to note that Ozempic has been shown to have cardiovascular benefits, as reported in the 2024 review 1, which can be an important consideration for patients with type 2 diabetes. Overall, the current safety data on Ozempic suggest that it can be a safe and effective treatment option for many patients with type 2 diabetes, when used appropriately and with careful monitoring 1.

From the FDA Drug Label

Data Animal Data In a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01,0.03 and 0.09 mg/kg/day (0.1-, 0.4-, and 1. 1-fold the MRHD) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to Gestation Day 17. In parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure. In an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010,0.0025 or 0.0075 mg/kg/day (0.03-, 0.3-, and 2. 3-fold the MRHD) were administered throughout organogenesis from Gestation Day 6 to 19. Pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. Early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at ≥0. 0025 mg/kg/day, at clinically relevant exposures. In a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015,0.075, and 0.15 mg/kg twice weekly (0.7-, 3.3-, and 7. 2-fold the MRHD) were administered from Gestation Day 16 to 140. Pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to delivery of slightly smaller offspring at ≥0.075 mg/kg twice weekly (>3X human exposure).

The current safety data on Ozempic (semaglutide) indicates that it may cause:

• reduced growth and fetal abnormalities in animal studies
• early pregnancy losses and increased incidences of minor visceral and skeletal fetal abnormalities in pregnant rabbits
• marked initial maternal body weight loss and reductions in body weight gain and food consumption in pregnant cynomolgus monkeys
• delivery of slightly smaller offspring in pregnant cynomolgus monkeys It is recommended to discontinue Ozempic in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide 2.

From the Research

Safety Data on Ozempic (Semaglutide)

The current safety data on Ozempic (semaglutide) is based on several studies that have evaluated its efficacy and safety in patients with type 2 diabetes.

• The studies have shown that semaglutide is associated with a low risk of severe adverse events, and its safety profile is similar to that of other GLP-1RAs 3, 4, 5, 6, 7.
• Common adverse events associated with semaglutide include gastrointestinal disturbances such as nausea, vomiting, and diarrhea 3, 5, 6, 7.
• The risk of hypoglycemia is low with semaglutide, especially when used as a monotherapy or in combination with other glucose-lowering therapies that do not increase the risk of hypoglycemia 5, 6.
• There is no increased risk of pancreatic cancer or thyroid cancer associated with semaglutide use, based on the available data from randomized controlled trials and real-world studies 3, 4, 5.
• Semaglutide has been shown to have a beneficial effect on cardiovascular outcomes, with a low risk of major adverse cardiovascular events 6, 7.
• The safety profile of oral semaglutide is consistent with the GLP-1RA drug class, with a low risk of hypoglycemia and a high incidence of gastrointestinal adverse events 6, 7.

Specific Safety Concerns

• Gastrointestinal side effects: Semaglutide is associated with an increased risk of gastrointestinal side effects, including nausea, vomiting, and diarrhea 3, 5, 6, 7.
• Pancreatic safety: There is no increased risk of pancreatic cancer or pancreatitis associated with semaglutide use, based on the available data from randomized controlled trials and real-world studies 3, 4, 5.
• Thyroid cancer: There is no increased risk of thyroid cancer associated with semaglutide use, based on the available data from randomized controlled trials and real-world studies 3, 4, 5.
• Cardiovascular safety: Semaglutide has been shown to have a beneficial effect on cardiovascular outcomes, with a low risk of major adverse cardiovascular events 6, 7.