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FDA: Clinical Trials Show Increased Risk of Amputation with Invokana

On Behalf of | May 17, 2017 | FDA Alerts

Recent safety communications published by the US Food and Drug Administration indicate that type 2 diabetes drug, Invokana (canagliflozin), can cause increased risk for foot and leg amputations. This announcement was made after data from two clinical studies showed that such amputations were necessary in nearly twice as many patients taking Invokana as compared to patients taking a placebo. As a result, the FDA has required Invokana manufacturer, Johnson & Johnson, to add new warnings to the drug’s labeling, including the administration’s most severe Boxed Warning.

What is Invokana?

Approved by the United States Food and Drug Administration (FDA) in 2013, Invokana is a form of sodium glucose cotransporter 2 (SGLT2) inhibitor that works to improve glycemic control in patients with Type II Diabetes. SGLT2 medications were released in 2013, after studies showed that they successfully helped to lower blood sugar levels in patients with the disease. Invokana, and other SGLT2 inhibitors, work by prompting the kidneys to remove glucose from the body at rapid rates through urine. However, the process can lead to the diminishment of all glucose within the blood, generating the necessity for the body to burn fat for energy, and in some cases causing ketoacidosis.

It was previously reported that SGLT2 inhibitors have been found to cause ketoacidosis in patients. This highly dangerous condition occurs when the body produces elevated levels of blood acidity known as ketones, and can cause many life-threatening side effects. The condition can eventually lead to death.

Previous Safety Communications

In May 2015, the FDA issued a safety announcement concerning SGLT2 inhibitors which stated that patients and physicians need to closely monitor side effects of drugs such as Invokana. The statement urged consumers to seek immediate medical attention should they experience even mild symptoms related to ketoacidosis, renal toxicity or heart attack.

FDA Safety Information

The FDA has provided guidance for patients and health providers considering these recent developments. The administration has specified that patients taking the medication should notify their physician if they experience any pain, infection, sores or ulcers in their legs or feet, but that they should not stop taking the medication without consulting with a medical professional.

Healthcare professionals should consider a patient’s medical history and possible factors that could predispose a patient to the need for amputations before prescribing Invokana (canagliflozin). These include previous instances of amputation, and a history of neuropathy, peripheral vascular disease or diabetic foot ulcers. The FDA has also requested that patients and medical professionals report adverse effects of Invokana to the MedWatch program.

Forced to Undergo Amputation While Taking Invokana?

Peter Angelos Law is prepared to help victims and their families, who have been harmed by pharmaceutical companies, to recover the compensation they deserve. To discuss your use of Invokana and our ongoing Invokana investigation, contact us for a no-charge consultation.