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Invokana Warnings FDA Strengthened

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Invokana-197x300Invokana warnings were strengthened by FDA June 14, 2016. The announcement topped the existing FDA warning made May 18, 2016. The agency wrote that recent reports prompted it to revise the warnings on Invokana’s label to include information about acute kidney injury. FDA also said that it added recommendations to minimize the risk of acute kidney injury from the type 2 diabetes medicines. In addition to Invokana, drugs included in the warning include Invokamet and Dapagliflozin (Farxiga, Xigduo XR).

Type 2 Diabetes Medications

Canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) are prescription medicines used to help lower blood sugar in adults with type 2 diabetes. These drugs belong to a class called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin and dapagliflozin lower blood sugar by causing kidneys to remove sugar through the urine.

FDA said in the June 2016 announcement that from canagliflozin’s approval in March 2013 through October 2015, it had received 101 confirmable case reports of acute kidney injury. Some required hospitalization and dialysis, with canagliflozin or dapagliflozin use. That number includes only reports submitted to FDA; the agency says there are likely additional cases not reported. (In point of fact, it is generally known that only some 10 percent of adverse drug reactions are reported to the FDA.)

Invokana Warnings FDA Strengthened

The FDA recommended that health care professionals consider factors that may predispose people to acute kidney injury before starting those people on canagliflozin or dapagliflozin. The agency said factors that may predispose people to kidney injury include “decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs).” The agency recommends assessing kidney function before beginning canagliflozin or dapagliflozin, and monitoring the patient periodically thereafter. FDA also said, “If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.”
Acute Kidney Injury

Acute kidney injury occurs when the kidneys quit working, which causes dangerous wastes to build in the body. Signs and symptoms of acute kidney injury can include low urine output, or swollen legs or feet. FDA cautioned that people should not quit their medicine without first consulting health care professionals. Stopping medication can trigger harmful, uncontrolled blood sugar levels.

Invokana Adverse Events

FDA requests that healthcare professionals and patients report adverse events or side effects related to the use of these drugs. Reports can be made to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.


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