Texas lawyer for Invokana ketoacidosis, kidney failure, heart attack, and stroke.June 15, 2016 — The FDA is strengthening warnings about kidney damage from several diabetes drugs in the SGLT2 inhibitor class, including popular medications like Invokana.

The agency issued a Safety Communication for the following diabetes drugs:

From March 2013, when Invokana was approved, until October 2015, the FDA received 101 confirmed case reports of acute kidney injury, some requiring hospitalization or dialysis. It is likely that additional cases were never reported to the FDA.

In about 50% of cases, acute kidney injury occurred within one month of starting the drug. Most patients improved after discontinuing it. In some cases, patients were under 65 years old, dehydrated, or taking other medications that could harm the kidneys.

Patients should seek medical attention immediately if they experience symptoms of acute kidney injury. According to the FDA:

“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 and other SGLT2 inhibitors control blood-sugar levels by forcing the kidneys to remove more sugar from the body in urine. In some cases, patients urinate so much they become dehydrated, which makes it hard for the kidneys to do their job.

The FDA identified several risk-factors for kidney injury, including:

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

Other medications also increase the risk, including diuretics, blood pressure medications known as angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and non-steroidal anti-inflammatory drugs (NSAIDs).

Unfortunately, millions of people with diabetes take these other medications to control blood pressure and nerve pain. NSAIDs include common painkillers like ibuprofen and naproxen. Diuretics are commonly prescribed in combination with ACE inhibitors or ARBs to control blood pressure.

Diuretics force a patient to urinate more often, which can exacerbate dehydration and reduce the amount of blood that passes through the kidneys. The kidneys can compensate by tightening blood vessels, but ARBs and ACE inhibitors interfere with this safety mechanism. In severe cases, the kidneys suddenly stop working.

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