Last week, DrugNews reported on new warnings from the FDA, European Medicines Agency and consumer group Institute for Safe Medication Practices that the popular diabetes drugs Invokana and Jardiance may increase the risk of ketoacidosis.
Since patients taking the drugs weren’t warned by the manufacturers of these deadly risks before, those diagnosed with ketoacidosis or kidney failure have begun an Invokana class action lawsuit in Canada and are coordinating special lawsuits here in the United States.
Now, the Association of British Clinical Diabetologists, the country’s leading diabetes physician group, has announced an audit of Invokana to determine if real world patients are experiencing the same complications and rate of effectiveness as found in the clinical testing.
Invokana, also known as the chemical canagliflozin, is an SGLT2-class drug prescribed to patients with type 2 diabetes. Since it was introduced in 2013, the FDA has recorded over 500 complaints of patients suffering elevated blood acid levels, a condition known as ketoacidosis. The agency has also received over 300 reports of kidney injury.
This prompted new warnings by the FDA last fall.
The new study, announced at a meeting of the Royal College of Physicians, will ask doctors to submit their findings for side effects, weight and blood sugar levels in patients currently taking Invokana.
Researchers hope to determine if the real world findings match those from the phase 3 clinical trials used to secure approval of the drug in the Unites States and Europe. They also hope to measure the drug’s impact on fat and blood pressure.
Despite the recently added warnings, there are no reports that either the FDA or EMA plan to issue an Invokana recall.
Lawyers are, however, offering help to those diagnosed with ketoacidosis or kidney damage after taking the drug. Based on the growing number of lawsuits against manufacturer Janssen, lawyers expect the cases will be combined into one central court for quicker handling.
For more information, or to speak directly with a lawyer, contact DrugNews today.
Canagliflozin Audit Examines ‘Real Life Benefits’. The Diabetes Times. (February 19, 2016). Retrieved from www.diabetestimes.co.uk
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