FDA Warnings


Research Findings and FDA Warnings

A short time after the SGLT2 inhibitors were released on the market, reports were filed about serious health problems related to these medications. Between March 2013 and May 2015, the FDA received information about at least 73 cases of acidosis diagnosed as diabetic ketoacidosis, ketoacidosis or ketosis. These patients were taking Invokana or other SGLT2 inhibitors and needed emergency room treatment or hospitalization.

The FDA has identified serious concerns about Invokana and other drugs. As a result, the agency issued the following safety alerts:

  • During the drug trials before FDA approval in 2013, patients taking Invokana had increased risks of developing fungal infections. Animal studies also indicated that long-term use of this medication could lead to extensive kidney damage, testicular and kidney cancers as well as bone abnormalities.
  • In 2013, the FDA reviewed CANVAS data on the side effects of Invokana. The results showed that the medication increased the risk of stroke by 46% in patients who took Invokana rather than a placebo. Dr. Mat Stroup, an FDA bio-statistician, concluded that patients who took Invokana had a 690% higher risk for cardiovascular problems versus than those who show did not take this medication.
  • In May 2015, a warning was issued about the side effects of Farxiga and other SGLT2 inhibitors. The alert noted that these diabetes drugs may cause diabetic ketoacidosis, acidosis or ketosis.
  • In September 2015, the FDA announced the requirement of new warnings about possible Invokamet and Invokana side effects. These include bone fractures and decreased bone density. The alert also indicates that fractures could occur as early as 12 weeks after beginning treatment.
  • In December 2015, the FDA required that labels on SGLT2 inhibitors include warnings about excess acid in the blood and serious urinary tract infections, which can result in hospitalization. Symptoms include a sense of urgency, burning, pain, fever or blood. The safety alert also warned patients about ketoacidosis (with symptoms such as nausea, vomiting, abdominal pain, tiredness and trouble breathing) and urged them to seek medical help promptly.
  • In April 2016, a study connected Invokana to an increased risk of ketoacidosis. The FDA also  released information that Invokana and other SGLT2 inhibitors may decrease bone density and increase the risk of bone fractures.
  • In May 2016, the FDA issued a safety alert, based on an ongoing clinical study. Findings indicated that patients taking Invokana and Invokamet were exposed to an increased risk of leg and foot amputations, mostly affecting the toes.
  • In December 2016, another warning was posted on the FDA website about the risk of ketoacidosis as an Invokana side effect and the need for reports as well as further research. This safety alert also included details about an increased risk of urosepsis, a severe urinary tract infection that may enter the blood. The problem has led to hospitalization, dialysis and kidney failure.

Although Invokana increases the risk of serious and potentially life-threatening side effects, the FDA has not recalled the medication.


Some Invokana lawsuits, which were filed in 2015, are in the preliminary stages. The discovery process has not started, and early settlements are not anticipated. The first cases, called bellwether trials, will determine the compensation for those suffering diabetes drug complications.

Settlements generally offer funds to help cover expenses incurred from Invokana injuries. Compensation is sometimes offered for:

  • Funeral expenses, if a patient dies
  • Loss of companionship
  • Lost income or inability to work
  • Medical expenses

An Invokana lawyer, who has extensive knowledge of other dangerous medications, can help you file a lawsuit. If you or loved one experienced serious health complications after taking medicine for diabetes or schizophrenia, you may be entitled to compensation. It is important to take action now.

Do you need legal advice about Invokana side effects or injuries suffered from another dangerous medication? Contact our firm for a free, confidential legal consultation.

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