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FDA Strengthens Kidney Injury Warnings for Diabetes Drugs

FDA Strengthens Kidney Injury Warnings for Diabetes Drugs

June 15, 2016 — The FDA has strengthened warnings about the risk of acute kidney injury from several popular diabetes drugs, especially when patients are also taking common painkillers, blood pressure drugs, or diuretics.

The warnings were issued for canagliflozin (Invokana and Invokamet) and dapagliflozin (Farxiga and Xigduo XR).

These drugs were responsible for 101 confirmed cases of acute kidney injury from March 2013, when Invokana was approved, until October 2015.

About half of the victims developed acute kidney injury within a month, and most improved after discontinuing the drug. Some of the patients were under 65, dehydrated, or on other medications with kidney risks.

The FDA asks patients to seek emergency medical attention if they develop symptoms of acute kidney injury:

“This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet.”

Invokana, Invokamet, Farxiga, and Xigduo XR control type-2 diabetes by forcing the kidneys to remove more sugar from the body in urine. Patients can urinate so much they become dehydrated, which decreases blood-volume and impairs kidney function.

According to the FDA, risk-factors for acute kidney injury include:

  • Decreased blood volume
  • Chronic kidney insufficiency
  • Congestive heart failure

The FDA also said the risk increases for patients on diuretics, blood pressure drugs known as angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and non-steroidal anti-inflammatory drugs (NSAIDs).

These common medications are used by millions of people with diabetes to control blood pressure and nerve pain. NSAIDs include painkillers like ibuprofen and naproxen. ACE inhibitors and ARBs are often prescribed in combination with diuretics to prevent hypertension.

Diuretics can cause dehydration, which makes it hard for the kidneys to do their job. The kidneys can compensate by tightening blood vessels, but this does not work when patients are on blood pressure medications. In severe cases, the kidneys suddenly stop working.

Do I have a Kidney Failure Lawsuit?

The Schmidt Firm, PLLC is currently accepting diabetes drug induced injury cases in all 50 states. If you or somebody you know has been diagnosed with kidney damage, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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