People with type 2 diabetes have an urgent need to lower their blood sugar levels in order to maintain their health and prevent dangerous complications such as kidney damage, heart disease, and blindness. Diet and exercise can help lower blood sugar levels, but many people with type 2 diabetes also need a prescription medication in order to get their blood sugar, or blood glucose, levels back into a healthy range.
In recent years a new class of type 2 diabetes medications has been developed. This class is known as sodium-glucose contransporter-2 (SGLT2) inhibitors. Invokana and Invokamet, known generically as canagliflozin, are SGLT2 inhibitors that work by removing sugar from the body through the kidneys.
Invokana was approved by the Federal Drug Administration (FDA) in March 2013. Since then, however, warnings and concerns about the drug’s safety have been raised around the world. Specifically:
- In December 2014, researchers from the National Institute of Diabetes and Digestive Kidney Diseases announced that SGLT2 inhibitors could increase the risk of bone fractures.
- In May 2015, the FDA warned that patients taking Invokana could be at an increased risk for suffering from ketoacidosis, a dangerous condition that occurs when the body produces too many ketones and the blood becomes too acidic.
- In June 2015, the European Medicines Agency (EMA) began investigating the link between SGLT2 inhibitors and ketoacidosis.
- In September 2015, a class action lawsuit was filed in Canada alleging that Janssen Pharmaceuticals failed to warn doctors about the risks of Invokana and was negligent in its testing of Invokana and that, as a result, patients suffered ketoacidosis and kidney failure.
Additionally, the FDA, lawyers in the United States, and others continue to have concerns about the safety of these drugs generally and Invokana specifically.
FDA Issues New Invokana Warning
In September 2015, the FDA issued a new safety announcement regarding Invokana and Invokamet. New information related to decreased bone mineral density and the increased risk of bone fractures was identified for Invokana and Invokamet users.
Invokana and Invokamet warning labels were revised to include a new Warning and Precaution section and to update the Adverse Reactions section. The new information indicates that there is an increased risk of bone fractures after just 12 weeks of using the medication.
When the FDA approved Invokana, the agency required that several post-market safety studies be conducted. One of those studies was a bone safety study. The post-market study regarding bone safety concluded that Invokana and Invokamet increase the risk of bone fracture for all patients, but most significantly for post-menopausal women. Specifically, it was found that older patients who took one of these drugs for more than two years had decreased bone mineral density in their hips and lower spines. This could make a bone fracture more likely.
Bone fractures can be dangerous, particularly for older patients, because they can result in dangerous falls or extended hospitalizations, both of which may be life-threatening. Elderly patients who recover from fractures may also be at risk of another fall in the future and may suffer permanent loss of mobility. Accordingly, doctors are being urged to consider patients’ risk of fractures before prescribing Invokana or Invokamet to treat type 2 diabetes.
Other Dangers of Invokana Have Already Been Identified
In May 2015, the FDA warned that Invokana could lead to ketoacidosis—a dangerous medical condition that is rarely seen in type 2 diabetes patients. Ketoacidosis occurs when too many ketones are released into the blood. This makes the blood too acidic and can result in coma or death.
In December 2015, the FDA added additional warnings regarding the risk of ketoacidosis and serious urinary tract infections to SGLT2 inhibitors, including Invokana. Patients were warned to stop taking their SGLT2 inhibitor immediately and seek emergency medical care if they exhibit symptoms of ketoacidosis such as nausea, vomiting, abdominal pain, tiredness, and trouble breathing. Patients were also encouraged to be aware of symptoms of urinary tract infections which include a feeling of burning when urinating or the need to urinate often or urgently; pain in the lower part of the stomach area or pelvis; fever; or blood in the urine. Anyone experiencing these symptoms should seek prompt medical attention. Life-threatening kidney infections can result from urinary tract infections.
Heart attacks, particularly within the first 30 days of using Invokana, have also been reported from Invokana clinical trials.
Contact Gray & White Law If You’ve Been Hurt by Invokana
There was much excitement when Invokana (canagliflozin) and Invokamet came on the market. The hope was that these drugs would help maintain or improve the health of people with type 2 diabetes. Unfortunately, some people have been serious injured instead. If you have been hurt or your loved one has died from an Invokana, canagliflozin, or Invokamet side effect then you may have a legal claim against the drug’s manufacturer.
The experienced drug injury lawyers of Gray & White Law can help you understand your rights and fight for your fair and just recovery. Gray & White Law is available 24 hours a day, seven days a week to answer your questions. Please call 888-403-4456 to speak with a member of our legal team.