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Is Jardiance a high risk medication? Unpacking the Safety Profile

3 min read

While Jardiance (empagliflozin) is widely used for conditions like Type 2 diabetes and heart failure, its safety profile warrants careful consideration. Serious adverse events, including a rare but life-threatening condition called ketoacidosis, have been reported in patients taking Jardiance, requiring a thorough understanding of its risks.

Quick Summary

This article explores the risks associated with Jardiance, detailing its mechanism, common and serious side effects, patient-specific risks, and comparisons with other diabetes medications.

Key Points

  • Overall Risk Profile: Jardiance is not a universally high-risk medication but carries specific, serious risks that necessitate careful patient selection and monitoring.

  • Ketoacidosis Risk: A life-threatening complication, more prevalent in Type 1 diabetics but possible in Type 2, can occur even with normal blood sugar.

  • Genital and Urinary Infections: Increased incidence of genital yeast and serious urinary tract infections, requiring appropriate monitoring and treatment.

  • Amputation Caution: Patients with pre-existing peripheral artery disease or diabetic foot problems may have an increased risk of lower limb amputation.

  • Not for Everyone: Contraindicated in patients with Type 1 diabetes, severe kidney problems, and certain immunosuppressive conditions.

  • Dehydration Risk: Its diuretic effect can cause dehydration and potentially lead to acute kidney injury, especially in elderly or kidney-impaired patients.

  • Fournier's Gangrene Warning: A rare but serious and potentially fatal bacterial infection of the perineum has been reported.

In This Article

Jardiance, also known by its generic name empagliflozin, is a prescription medication in the class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. It is FDA-approved to treat Type 2 diabetes, chronic kidney disease (CKD), and heart failure. It works by inhibiting the SGLT2 protein in the kidneys, which helps the body remove excess glucose through urine. This process not only lowers blood sugar but has also demonstrated significant cardiovascular benefits, including reducing the risk of cardiovascular death in adults with Type 2 diabetes and known heart disease.

How Jardiance Works and its Benefits

Jardiance lowers blood glucose by preventing the kidneys from reabsorbing sugar back into the blood, instead causing it to be expelled in the urine. This unique mechanism is also responsible for many of its beneficial effects beyond glycemic control. For heart failure patients, Jardiance helps by reducing sodium and fluid retention and improving the heart's energy usage, which can decrease the risk of cardiovascular death and hospitalization. For patients with CKD, it is used to reduce the risk of further kidney function decline and cardiovascular death.

Common Side Effects

Common side effects of Jardiance may include genital yeast infections, urinary tract infections, and increased urination, which can lead to thirst and mild dehydration. Some patients may also experience upper respiratory tract infections or nausea.

Serious and Potentially High-Risk Side Effects

More serious, though less frequent, side effects can occur, including diabetic ketoacidosis (a potentially life-threatening condition), dehydration which can lead to acute kidney injury, severe urinary tract and genital infections, and a rare but severe infection called necrotizing fasciitis (Fournier's gangrene). There may also be an increased risk of lower limb amputations, particularly for those with pre-existing conditions, and the risk of low blood sugar increases when Jardiance is taken with insulin or sulfonylureas.

Is Jardiance a High Risk Medication? Assessing the Risk-Benefit Profile

Jardiance is not universally classified as a "high-risk" medication; the risk depends on the individual patient. For many patients, the cardiovascular and renal benefits may outweigh potential side effects. A healthcare provider should assess individual risks and benefits, especially for elderly patients or those with kidney issues, who may face higher risks.

Comparative Safety: Jardiance vs. Other Diabetes Medications

The table below compares Jardiance with other diabetes medications based on mechanism, benefits, and side effects:

Feature Jardiance (SGLT2 Inhibitor) Januvia (DPP-4 Inhibitor) Ozempic (GLP-1 Receptor Agonist) Metformin (Biguanide)
Mechanism Increases glucose excretion via urine. Increases insulin production, decreases sugar production. Stimulates insulin release in response to blood glucose. Reduces glucose production in the liver.
Cardiovascular/Renal Benefits Proven to reduce CV death and improve heart failure/CKD outcomes. No direct cardiovascular benefit for heart failure or CKD. Reduces major CV events. Some evidence of CV benefits, less clear than Jardiance.
Common Side Effects Genital yeast infections, UTIs, increased urination. Upper respiratory tract infections, joint pain. Nausea, vomiting, diarrhea. Nausea, diarrhea, stomach upset.
Serious Side Effects Ketoacidosis, necrotizing fasciitis, amputation risk. Pancreatitis, severe joint pain. Thyroid cancer risk, pancreatitis. Lactic acidosis (rare but serious).

Jardiance offers significant cardiovascular benefits, particularly for those with heart failure, distinguishing it from some other treatments. While generally tolerable, the possibility of certain side effects like infections and rarer serious events like ketoacidosis means its use requires careful consideration.

Conclusion

Jardiance is an effective treatment for Type 2 diabetes, heart failure, and chronic kidney disease, providing notable cardiovascular and renal benefits. However, the potential for serious side effects, such as ketoacidosis, severe infections, and a potential risk of amputation, necessitates careful patient selection and monitoring. It is not appropriate for all patients, including those with Type 1 diabetes or significant kidney impairment. Consulting with a healthcare provider is essential to weigh the benefits against the risks for individual circumstances. Patients should be informed about the warning signs of serious complications and seek immediate medical attention if needed. For more detailed information, patients can consult the Prescribing Information available on the {Link: FDA website https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf}.

Frequently Asked Questions

No, Jardiance is not considered high-risk for all patients. Its risk profile depends heavily on an individual's health status and pre-existing conditions. For many, its cardiovascular and renal benefits outweigh the risks. However, for certain patients with specific risk factors, it does carry a higher risk of serious adverse events.

The most serious, though rare, side effects include ketoacidosis (a potentially fatal buildup of acids in the blood), necrotizing fasciitis (Fournier's gangrene), severe dehydration, and acute kidney injury.

Jardiance is not recommended for patients with Type 1 diabetes, severe kidney disease or those on dialysis, or anyone with a history of a serious allergic reaction to empagliflozin.

Some clinical studies have shown an increased risk of lower limb amputations in patients taking SGLT2 inhibitors like Jardiance. The risk is highest for those with a history of peripheral artery disease, diabetic foot problems, or previous amputations.

While Jardiance on its own has a low risk of causing hypoglycemia, the risk increases significantly when it is combined with other diabetes medications such as insulin or sulfonylureas.

Fournier's gangrene is a rare but serious and life-threatening bacterial infection of the tissue in the genital and anal area. Cases have been reported in patients taking Jardiance, and it requires immediate medical attention.

Jardiance's safety profile is unique compared to other diabetes medications like DPP-4 inhibitors (Januvia) or GLP-1 agonists (Ozempic), which have different common and rare side effects. When compared to metformin, Jardiance has fewer common side effects but carries more serious potential risks.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.