SUMMARY: On June 22, 2015 Health Canada sent a MedEffect email alert about its “Information Update – Forxiga, Invokana: Health Canada begins safety review of diabetes drugs known as SGLT2 inhibitors and risk of ketoacidosis”.
From that email alert we get this:
Health Canada initiated a safety review for the prescription diabetes drugs [Forxiga / Farxiga (dapagliflozin)] and [Invokana (canagliflozin)] and the risk of ketoacidosis, a serious condition that leads to high levels of blood acids called ketones….
In May 2015 the FDA had announced it was investigating a association between Farxiga, Jardiance, and Invokana with diabetic ketoacidosis (DKA), ketoacidosis, or ketosis. See: “FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood”.
Next, from the May 6, 2015 edition of ISMP QuaterWatch, we get this information about Invokana-related kidney failure:
In March of 2013, the FDA approved… [Invokana (canagliflozin)] and its mechanism of action was to inhibit a normal function of the kidney, which is to return any glucose to the blood circulation while excreting other undesirable substances. Instead, [Invokana (canagliflozin)] causes substantial amounts of sugar to be excreted in the urine. In the first year of adverse event data, we saw reports indicating serious injuries involving kidney function…
In the first year after approval… we identified 457 serious adverse event reports, including 5 different adverse effects directly or indirectly related to the renal toxicity of [Invokana (canagliflozin)]. This included kidney failure or impairment ([number] = 54)….
This so-called drug safety “signal” for Invokana-related kidney failure seems applicable, also, to the other sodium glucose cotransporter-2 (SGLT2) diabetes drugs: Farxiga; Jardiance; Invokamet; Xigduo XR; and, Glyxambi.
We are currently investigating possible drug injury cases for people with Type-2 diabetes who used one of these SGLT2 diabetes drugs and developed ketoacidosis or kidney failure, as well as when these diabetics suffer a heart attack (MI), stroke (CVA), or heart failure.[Read this article in full at original source]
Invokana / Farxiga / Jardiance
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