Even When You Know The Truth…It Still Hurts

Diabetes Mellitus Type-2 (DM Type-II) is an illness that can lead to a series of serious complications that result in blindness, kidney failure, amputations, and ultimately death. A standard first line of defense against this disease is controlling one’s weight, eating a balanced diet, and a regular exercise regimen. When these combined efforts do not achieve acceptable blood glucose levels (HbA1c), doctors will prescribe anti-diabetic medications. Unfortunately, the side effects of some of the medications prescribed with the aim of improving the health status of DM Type-II patients create far greater problems than they solve.

On March 29, 2013, the Federal Drug Administration (FDA) approved a new class of adult anti-diabetic oral medications, called sodium glucose co-transporter two (SGLT-2) inhibitors, as a stand-alone treatment option. These particular drugs are intended to lower blood glucose levels by preventing re-absorption of glucose into the bloodstream through the kidneys and then its’ subsequent excretion through urination. Clinical studies of patients using SGLT-2 inhibitors canagliflozin, brand name Invokana) determined that they obtained lower HbA1c levels, lost weight, and experienced mild to moderate adverse reactions…but there was more to this story than was revealed at its’ public debut on the market.

invokana

The FDA approved the use of this drug as safe and effective based on nine clinical trials that were performed before it was released. These clinical trials administered SGLT-2 inhibitors (canagliflozin) as a stand-alone therapy and in combination with other DM Type-II medications. It was contraindicated to prescribe this drug to patients with diabetic ketoacidosis (elevated blood acid levels called ketones) or serious renal dysfunctions. Thereafter the FDA required five more post-market studies to ascertain other adverse effects related to the use of canagliflozin (Invokana).

On August 8, 2014, The FDA granted fast-track approval for canagliflozin in combination with metformin (a biguanide class of anti-diabetic drug) as a treatment option for DM Type-II patients. Biguanides work by simultaneously decreasing the amount of glucose produced by the liver while increasing insulin sensitivity (improving the ability of the body to use its’ own insulin). Less than a year later problems began surfacing in relation to this expanded use of canagliflozin.

invokana canagliflozin

The Federal Drug Administration issued the following notifications regarding the use of SGLT-2 inhibitors (canagliflozin, brand name Invokana):

On May 15, 2015, a warning that the use of canagliflozin may lead to severe ketoacidosis (elevated blood acid levels called ketones) requiring hospitalization.

On May 18, 2016, an alert that ongoing clinical trials found an increase in leg and foot amputations (mostly the toes) in patients using the anti-diabetic drug canagliflozin.

On June 14, 2016, a repeated warning about the risk of kidney damage, the severity of which could cause the kidneys to suddenly cease to function leading to dangerously elevated levels of waste in the body.

On September 10, 2016, a labeling revision to include information that SGLT-2 inhibitors increase the risks of bone fractures and that they decrease bone mineral density.

Any reasonable person would come to the conclusion that the litany of harm that has already been attributed to Invokana side effects would prompt an immediate recall of the product. It seems that even when the truth is known, it doesn’t prevent a greater harm. Medicine is supposed to be good for, isn’t it?.

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