Diabetes Drug Gets FDA Warning Due to Amputation Risk

by DailyHealthPost

Type 2 diabetes affects 27 million people in the U.S. Another 86 million have prediabetes (1). It occurs when your cells are no longer able to use insulin properly. In response, your pancreas begins to create more insulin, which begins a vicious cycle that may eventually wear out the pancreas from working overtime. Because your cells can’t absorb glucose properly, your blood sugar levels end up dangerously high.

While the condition can be treated by tackling lifestyle factors such as obesity and a high-sugar diet, many diabetics use pharmaceuticals to manage their condition.

Common diabetes drugs include (2,3):

  • Canagliflozin  (Invokana, Invokamet, Invokamet XR)
  • Metformin (Glucophage, Glumetza, others)
  • Sulfonylureas
  • Meglitinides
  • Thiazolidinediones
  • DPP-4 inhibitors
  • GLP-1 receptor agonists
  • SGLT2 inhibitors
  • Insulin (Apidra, Humalog, Novolog, Lantus, Levemir, Humulin N, and Novolin N)

The Risks of Pharmaceuticals

Canagliflozin is an oral tablet that lowers blood sugar by causing the kidneys to get rid of more glucose in the urine.

It’s known to cause serious side effects such as frequent, urgent, burning, or painful urination, pelvic or rectal pain, genital problems, tingling in arms and legs, ulcers or other sores on the skin of the legs or feet, and more.

And that’s just the beginning.

The FDA has recently issued this warning: “Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.” (4)

Their investigation found that patients taking the drug were twice more likely to suffer amputation than diabetics who were treated with a placebo in two separate studies. Toe and foot amputation were more likely although leg amputation also occurred in patients taking the drug.

This problem began with pain, tenderness, numbness, sores and ulcers. As these sores worsened and become infected, amputation became medically necessary.

The FDA now recommends that the drug should not be prescribed unless patients are closely monitored by their physician. At any sign of adverse reaction, patients should be weaned off the drug immediately. Additionally, patients with a history of prior amputation, peripheral vascular disease, neuropathy, and/or diabetic foot ulcers should not be prescribed the drug.

Instead of taking these dangerous drugs, health professionals now suggest that diabetics should focus on improving their condition through exercise and healthy eating habits.

sources: PulseHeadlinesPrescriptionDrugJournal

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