Last year, the FDA warned that a new class of diabetes drug known as SGLT2 inhibitors may increase the risk of a dangerous blood condition called ketoacidosis. These drugs are commonly known by brand names like Invokana, Farxiga and Jardiance.
This year, the European Medicines Agency followed with similar warnings, and the consumer safety group Institute for Safe Medication Practices published a report noting a spike in side effect reports to the FDA for SGLT2 drugs like Invokana. Many of these were due to ketoacidosis.
Ketoacidosis is a condition where the blood develops dangerously high levels of acid, which can cause severe injury, hospitalization or even death.
Now, with an increase in the overall number of ketoacidosis cases, a new study published this month sought to identify factors associated with the disease, as well as the effect on death rate when patients are hospitalized numerous times.
Recurrent Ketoacidosis Increased Death Rate
Researchers from Scotland examined records from over 600 hospital admissions in the United Kingdom for patients with ketoacidosis between 2007 and 2012. They also noted discharge and follow up records for each individual.
The data revealed that patients with recurrent admissions for ketoacidosis had nearly four times the rate of antidepressant use, and nearly five times the risk of death.
The results, first unveiled at last year’s American Diabetes Association conference, were published in the July issue of the journal Diabetologia.
FDA Records Show Rise in Invokana Ketoacidosis
A review of current FDA public records shows the agency has received over 700 reports of patients suffering ketoacidosis while using Invokana (canagliflozin) since the drug was approved in 2013.
SGLT2 inhibitors like Invokana are designed to help those with type 2 diabetes control high blood sugar by restricting the absorption of glucose in the kidneys. They do this by triggering the kidneys to flush glucose from the bloodstream.
Invokana Lawsuits on the Rise
A review of court filings by DrugNews also shows the number of lawsuits filed against the maker of Invokana, Janssen Pharmaceuticals, is on the rise.
These are split between lawsuits for diabetic ketoacidosis caused by the drug, as well as kidney damage.
In Canada, lawyers have already formed an Invokana class action lawsuit for victims of kidney damage. In the U.S., lawyers are expected to try to consolidate Invokana ketoacidosis lawsuits into a central multidistrict litigation court for quicker handling.
Since Janssen has not issued an Invokana recall despite multiple FDA and consumer safety warnings, the number of cases is only expected to grow.
Lawyers are offering free help to those injured by ketoacidosis or kidney damage after using Invokana. For more information, or to speak directly to a lawyer about your case, contact DrugNews today.
Fraser, F. et al. Risk of death following admission to a UK hospital with diabetic ketoacidosis. Diabetologia. (July 11, 2016). Retrieved from www.springer.com
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