What are the potential side effects and risks of death associated with Ozenlic (generic name) use?

From the Guidelines

Ozenlic (ozanimod) can cause several potential side effects, but deaths directly attributed to the medication are extremely rare. The most common side effects of Ozenlic include nausea, vomiting, diarrhea, abdominal pain, and fatigue, which typically improve over time as the body adjusts to the medication. More serious side effects include macular oedema, infections, and liver enzyme elevation, which may require monitoring and treatment adjustment 1. According to the latest evidence, the occurrence of cancer, serious infection, and macular oedema with ozanimod is low, and no patients have met the criteria for Hy’s law to suggest drug-induced liver injury 1. Additionally, real-world data have shown that ozanimod is generally well-tolerated, with a low rate of adverse events and no reported deaths 1. However, certain patients may be at higher risk with ozanimod treatment, including those with pre-existing cardiac conditions, high risk for macular oedema, and concomitant use of cardiac or immunosuppressive medications 1. Therefore, it is essential to carefully evaluate the benefits and risks of Ozenlic and monitor patients closely for potential side effects, particularly in those with underlying health conditions. Key considerations for clinicians include:

• Monitoring for liver enzyme elevation and lymphopenia
• Assessing the risk of macular oedema and infections
• Evaluating the potential for drug-drug interactions
• Collaborating with general internists for patients with comorbidities and risk factors 1. Overall, the available evidence suggests that Ozenlic is a relatively safe medication when used appropriately, but careful patient selection and monitoring are crucial to minimizing the risk of adverse events 1.

From the Research

Ozenlic Side Effects and Risks of Death

• The generic name for Ozenlic is semaglutide, which is used to treat type 2 diabetes and obesity.
• Studies have shown that semaglutide can have several side effects, including:
  • Weight gain and metabolic disturbances, such as pre-diabetes and diabetes 2
  • Pancreatitis, pancreatic, and thyroid cancer 3
  • Erectile dysfunction in non-diabetic, obese men 4
• There have been reports of fatal effects associated with semaglutide use, which has led to the addition of fatal effects to the list of side effects by regulatory agencies such as the FDA and ANSM 5
• The misuse of semaglutide, particularly among non-diabetic and non-obese populations, has become a public health concern 5, 6
• A study found that public attitudes towards off-label prescribing of semaglutide are split, with 46.3% supporting physician discretion to prescribe off-label, but 63% expressing concern about safety in the context of off-label use 6

Specific Side Effects and Risks

• Pancreatitis: semaglutide has been shown to increase the odds ratio for reported pancreatitis 6-fold compared to other therapies 3
• Pancreatic cancer: semaglutide has been associated with an increased risk of pancreatic cancer, with a higher rate of reported cases compared to other therapies 3
• Erectile dysfunction: semaglutide has been shown to increase the risk of erectile dysfunction in non-diabetic, obese men, with a risk ratio of 4.5 compared to a control cohort 4
• Testosterone deficiency: semaglutide has also been associated with an increased risk of testosterone deficiency in non-diabetic, obese men, with a risk ratio of 1.9 compared to a control cohort 4