The Sanders Firm is now reviewing potential lawsuits from patients who have suffered ketoacidosis, kidney failure, or other side effects from the type 2 diabetes drug Invokana. With type 2 diabetes on the rise in the US, drug companies like Johnson & Johnson (which manufactures Invokana) are tapping in to a lucrative market for medications that manage the condition.
However, the FDA and other organizations have raised safety concerns about Invokana as well as other drugs in the new class of diabetes medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.
It’s important that patients who have been harmed by Invokana understand their rights to legal representation and pursuing fair compensation for injuries sustained.
What is Invokana?
Invokana is the brand name of the drug canagliflozin, produced by Johnson & Johnson, and approved for sale in the US in 2013. It is one of a new class of type 2 diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. SGLT2 inhibitors function by causing the kidneys to pass excess glucose in the urine rather than putting this sugar into circulation in the blood.
SGLT2 inhibitors differ from older type 2 diabetes drugs which work primarily in connection to the amount or function of insulin. The drugs were marketed as offering certain advantages in addition to their effectiveness in managing type 2 diabetes, namely moderate weight loss and lower blood pressure for some patients. Johnson & Johnson was the first company to introduce SGLT2 inhibitors to the US market. The company achieved success early on: Invokana was prescribed almost half a million times by the second quarter of 2014.
Other examples of SGLT2 inhibitors include:
- Farxiga (or dapagliflozin, produced by AstraZeneca, approved January, 2014)
- Jardiance (or embagliflozin, produced by Eli Lilly, with Boehringer Ingleheim, approved August, 2014)
- Invokamet (combining canagliflozin and metformin hydrochloride)
- Xigduo XR (combining dapagliflozin and metformin)
- Glyxambi (combining empagliflozin and linagliptin)
While The Sanders Firm applauds the addition of new treatments for diabetes, we believe that drug companies need to act responsibly in determining the safety of their products and warning consumers about inherent dangers.
Risks associated with Invokana & SGLT2 inhibitors
Invokana has been associated with a potentially fatal build up of acid in the blood known as ketoacidosis.
SGLT2 inhibitors have also been associated with other serious side effects, such as:
- Kidney failure
- Heart attack
Invokana and ketoacidosis
The FDA recently issued a safety announcement concerning SGLT2 inhibitors such as Invokana and ketoacidosis, a condition which involves high levels of ketones (acid) in the blood. Without treatment, ketoacidosis can lead to dehydration, loss of consciousness, coma, and even death.
While usually it is type 1 diabetes patients who are at risk for ketoacidosis, the FDA’s safety communication of May 15, 2015 listed 20 adverse events involving ketoacidosis among SGLT2 inhibitor users between March 2013 to June 6, 2014, with additional reports coming in subsequently. None of the patients died, though all required hospitalization or emergency room visits.
Kidney failure claims
The Institute for Safe Medication Practices (ISMP) has made a number of kidney failure claims in connection to Invokana. In their quarterly report of May 21, they itemized 457 serious adverse event reports (SAER) associated with Invokana, including the following kidney-related side effects:
- Kidney failure or impairment: 54 instances
- Kidney stones: 11 instances
- Dehydration and fluid imbalances: 54 instances
- Urinary tract infections: 50 instances
Invokana heart problems
The FDA required Johnson & Johnson to perform five post-market studies of Invokana side effects after its approval in 2013. The significance of cardiovascular side effects detected in one of these studies, the Canagliflozin Cardiovascular Assessment Study (CANVAS), released in 2015, has been debated.
The study, involving 4330 participants at risk for cardiovascular events, found that although there was an elevated risk for stroke and heart attack during the first 30 days of usage (13 patients suffered a stroke or heart attack compared to one person taking a placebo), this risk was actually reduced after the initial 30 days.
Though some see the numbers as suggestive of low cardiovascular risks, others believe that more research is necessary.
Grounds for filing an Invokana lawsuit
Given the large number of patients who have used Invokana to regulate their blood glucose levels, the potential for mass litigation in the Unites States is significant.
Claims may be based on the following causes of action:
- Failure to warn of side effects
- Manufacturing or design defects
- Fraudulent or negligent misrepresentation
Patients who have experienced severe side effects such as ketoacidosis or kidney failure after taking Invokana may have a valid claim for damages. However, there are statutes of limitation to file a lawsuit, making it important to retain legal counsel as soon as possible.
The Sanders Firm is a nationally-acclaimed practice with five decades of experience litigating dangerous drug lawsuits. If you took Invokana and were hospitalized or incurred injury, please contact our office at 1-800-FAIR-PLAY (1-800-324-7752) to arrange a free case review and discuss your options for legal recourse.
- Health Canada, Information Update - Forxiga, Invokana: Health Canada begins safety review of diabetes drugs known as SGLT2 inhibitors and risk of ketoacidosis http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/forxiga-invokana-eng.php
- Reuters, FDA warns on newer class of type 2 diabetes drugs http://www.reuters.com/article/2015/05/15/us-fda-diabetes-idUSKBN0O01P520150515
- FDA, FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm
- ISMP, New Safety Perspectives http://www.ismp.org/quarterwatch/
- Forbes, New Diabetes Drug Invokana Has Major Treatment - And Market – Potential http://www.forbes.com/sites/melaniehaiken/2013/04/01/invokana-a-potential-blockbuster-diabetes-drug-approved-by-the-fda/
- NY Times, F.D.A. Approves a New Diabetes Drug From J.&J. http://www.nytimes.com/2013/03/30/business/invokana-wins-fda-approval-for-diabetes-treatment.html?_r=1