Thursday, November 10, 2016

Lawsuits Filed Over Diabetes Drug Invokana After FDA Warns of Ketoacidosis, Life-Threatening Infections

Originally published by robertslawfirm.

The Food and Drug Administration (FDA) issued warnings regarding several popular Type 2 diabetes drugs earlier this year, including Johnson & Johnson’s Invokana that may cause serious and life-threatening complications. The FDA’s initial safety review of these medications began in May of 2015 after the agency received multiple reports that Invokana and other sodium-glucose cotransporter-2 (SGLT2) inhibitors could lead to diabetic ketoacidosis, a dangerous condition where the body produces high levels of acid in the blood. If left untreated, diabetic ketoacidosis can cause comas and eventually death. The FDA studied adverse event reports that had been submitted over two years, and found 73 instances where patients taking SGLT2 drugs developed diabetic ketoacidosis. Because these events are always underreported, the FDA decided to have pharmaceutical manufacturers change their warning labels to advise patients and doctors of the risk of developing ketoacidosis and serious urinary or kidney infections. Medication like SGLT2 inhibitors treat Type-2 diabetes by keeping the kidneys from absorbing glucose. People with Type-2 diabetes have problems regulating their blood sugar, and these medications prevent the kidneys from absorbing too much. Instead, the glucose (sugar) is passed through urination without being absorbed. Unfortunately, these drugs can also cause the body’s levels of glucose and insulin to drop too low. As a result, the body will start burning fatty acids, which can build up in the bloodstream causing diabetic ketoacidosis. Additionally, too much sugar in the urinary tract can lead to infections that may spread to the kidneys. While SGLT2 drugs carried […]

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from Texas Bar Today http://www.robertslawfirm.com/blog/2016/11/lawsuits-filed-diabetes-drug-invokana-fda-warns-ketoacidosis-life-threatening-infections/
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