FDA Stengthens Invokana’s Label to Reflect Severe Kidney Damage
This is Amy German, Managing Associate attorney for The Michael Brady Lynch Firm.
The FDA just revised Invokana’s labeling to warn of acute kidney damage when taking canagliflozin, the active ingredient in the Type 2 Diabetes drug. The label changes come on the heels of surfacing reports, which state that since Invokana’s approval in March 2013, the FDA received 101 confirmed cases of acute kidney damage, which lead to hospitalization and dialysis for many.
Manufactured by Johnson & Johnson, Invokana is a class of drug that lowers blood sugar by causing the kidneys to remove sugar from the body via urine. Patients are at risk of urinating so much that it leads to dehydration. This prevents the kidneys from filtering properly and increases the risk of kidney failure.
Along with the label change, the FDA also advised doctors and health care professionals to consider risk factors that could predispose patients to acute kidney damage. These include low blood volume, congestive heart failure, and certain medications. The medications include diuretics, blood pressure medications known as angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and non-steroidal anti-inflammatory drugs (NSAIDs).
The issue is that a large percentage of people with diabetes need to take these medications, too. Diuretics are often prescribed in combination with ACE inhibitors or ARBs to control blood pressure. NSAIDs include common painkillers like ibuprofen.
Please seek immediate medical attention if you display any signs of severe kidney damage, which includes decreased urine and swelling of lower extremities.
If you or a loved one suffered kidney damage after taking Invokana, contact us today at 877-513-9517.