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Patients Claim that Johnson & Johnson Failed to Warn Them About the Risk of Ketoacidosis and Other Serious Side Effects

White Invokana Pills Spilling Out of a BottleInvokana (known by the generic name canagliflozin) is a relatively new medication intended to help treat type 2 diabetes, and was first approved for use by the Food and Drug Administration (FDA) in 2013. It is currently marketed in the United States by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Since the very beginning, though, there have been protests that this drug may not be as safe as the manufacturer claims.

What Is Invokana?

Invokana belongs to a class of drugs called subtype 2 sodium-glucose transport (SGLT-2) inhibitors that are designed to help reduce blood sugar. This type of drug works primarily in the kidneys, by blocking certain proteins responsible for reabsorbing excess blood sugar. The result is that the extra sugar is lost in the urine instead of returning to the blood. Unfortunately, this method of treatment comes with risks that may not have been properly disclosed by the manufacturer.

SLGT-2 Inhibitors and Ketoacidosis Risk

One of the most dangerous complications of Invokana and other SGLT-2 drugs is ketoacidosis. When the body is low on sugar or unable to process sugar, it begins to use ketone bodies as fuel as an alternate source of energy. The waste products of this process are called ketones, which can build up in the body and cause toxic side effects, including:

  • Exhaustion
  • Mental confusion or difficulty focusing
  • Nausea and vomiting
  • Abdominal pain
  • Sweet, fruity odor in the breath, similar to nail polish remover
  • Excess thirst and frequent urination

If left untreated, ketoacidosis can be fatal. It is a medical emergency and requires immediate care to prevent lapsing into a coma and eventual death.

The FDA issued a Drug Safety Notice in May 2015 linking Invokana and other SGLT-2 inhibitor drugs to this condition. The notice states that patients taking Invokana (canagliflozin), Invokamet (a combination of canagliflozin and metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin, an extended-release formulation), Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin), or Synjardy (empagliflozin and metformin) are all at risk and should seek medical attention immediately if they notice any symptoms of ketoacidosis.

Increased Risk of Kidney Infections

Another potentially lethal side effect of Invokana is a kidney infection, caused by a urinary tract infection (UTI). The FDA issued a Safety Announcement in December of 2015 linking not only Invokana but other SGLT-2 drugs or drug combinations to this dangerous condition. Symptoms of a kidney infection include:

  • Side, back, or groin pain
  • Abdominal pain
  • Unexplained fever
  • A strong and persistent need to urinate
  • Burning sensation during urination
  • Blood or pus in urine
  • Cloudy or foul-smelling urine
  • Nausea or vomiting

Kidney infection can lead to septicemia (blood poisoning) as the infection spreads into the rest of the body. It can also cause permanent kidney damage, resulting in the need for dialysis or even an organ transplant.

Other Risks: Blood Clots, Heart Attacks, and Strokes

Invokana has also been linked to increased cardiovascular risks, including heart attacks or strokes. Even while it was gaining approval for sale in 2013, early clinical trials showed that it increased the risk for both. Due to the extra fluid loss caused by frequent urination, Invokana causes the blood to thicken—this increases the risk of blood clots, which can then lead to stroke or heart attack. Invokana is also known to elevate LDL cholesterol (low-density lipoprotein or “bad” cholesterol) levels, which is a known risk factor for increased chance of heart attack.

Help for Invokana Patients

Even before it hit the market in the United States, experts were warning about the risks of Invokana, yet the company still proceeded to seek approval and sell the drug. The time has come for patients to fight back against drug companies that push drugs to market without warning consumers of the potential dangers.

If you or someone you love has been injured due to taking Invokana, you may be owed compensation, and Wayne Wright LLP would like to hear from you. Call us today for a free, zero-obligation consultation about your legal situation at 800-237-3334.