Diabetes Drug Invokana Linked to Cardiovascular Risks and Diabetic Ketoacidosis
Invokana (canagliflozin) was approved by the FDA in March 2013 to treat patients who suffer from Type 2 diabetes. It is prescribed to improve glycemic control and to lower blood sugar in adults with Type 2 diabetes mellitus. Diabetes causes serious medical problems and is one of the leading causes of death in the United States.
Invokana is the market leader of a new class of drugs that are designed to treat Type 2 diabetes in a manner that has not been done before––through the kidneys. This class of drugs is called Sodium-glucose Cotransporter (Sglt2) Inhibitors.
The use of Sglt2 Inhibitors has skyrocketed since their approval. Janssen Pharmaceuticals, who markets Invokana is promoting the drug not only for Type 2 diabetes, but also for off-label purposes such as weight loss and blood pressure control, and through its marketing efforts, Janssen has garnered a $1 billion market share for Invokana.
Invokana and Cardiovascular Risks
In January 2013, the FDA Advisory Committee presented concerns regarding the cardiovascular safety of Invokana. These concerns were based on a preliminary canvas trial in which reports of heart attacks and strokes were more than 10 times higher for trial patients who had been given Invokana than for patients who had been given a placebo.
Despite these concerns, the FDA decided to allow Invokana to be marketed by Janssen but with a caveat––Janssen would have to do a follow-up canvas study of the drug’s cardiovascular safety. So, the initial canvas trials were extended until the year 2017. This means that since 2013, the drug has been allowed to be sold to American patients even with unresolved cardiovascular safety issues while Janssen continues to study its safety.
Invokana and Ketoacidosis
In May 2015, the FDA released a safety communication warning that Invokana treatment can put diabetes patients at risk for a condition known as ketoacidosis. Ketoacidosis, is a potentially fatal condition that occurs when the cells do not receive the glucose needed by your body to produce energy and the body begins to burn fat for energy. This produces ketones that can build up in your blood, making it more acidic and which can eventually poison your organs.
Diabetic Ketoacidosis can lead to serious health problems such as:
- Diabetic coma
- Kidney damage
- Blood Clots
- Heart attacks
Lawsuits are now being pursued against Janssen Pharmaceuticals alleging that the company failed to warn patients and their physicians of the increased risks heart attacks, strokes, ketoacidosis, and other serious complications associated with the drug.
Had physicians been warned of the risk of complications associated with treating their patients with Invokana, they may have prescribed an alternative medication and monitored their patients more closely.
These lawsuits also alleged that Janssen:
- Failed to adequately study the health risks associated with the drug
- Misrepresented the drug’s safety
- Failed to recall the drug when its danger became evident
Lawsuits against Janssen Pharmaceuticals seek compensation for both physical and psychological pain and suffering, disability, lost wages and medical expenses. In addition, wrongful death claims may also be pursued by family members.
Contact a Dangerous Pharmaceuticals Attorney
To find out if you are eligible for an Invokana drug settlement, contact a dangerous pharmaceuticals attorney for a free no-cost, no-obligation evaluation. There are strict deadlines for filing a claim, so don’t delay.
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