Questions about Invokana and other similar type 2 diabetes medications? Here are the top 10 things Invokana users and their families should know about the type 2 diabetes drug.
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10 - Invokana is an SGLT2 inhibitor and affects the kidneys
Sodium-glucose cotransporter 2 (SGLT2) inhibitors treat type 2 diabetes by forcing the kidneys to expel glucose (sugar) through the urine.
Due to its effect on the kidneys to treat type 2 diabetes, Invokana is believed to be linked to an increased risk of developing serious renal problems like kidney failure.
Other SGLT2 inhibitors include Invokamet (also marketed by Janssen), Farxiga, Jardiance, Glyxambi, and Xigduo XR.
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7 - Invokana may lead to urinary tract infections
Invokana is packaged with warning labels informing users the type 2 diabetes medication may cause urinary tract infections in both men and women.
Because Invokana forces the body to excrete excess glucose through urine, patients are placed at an increased risk of developing urinary tract infections and other serious health problems.
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5 - Health Canada and the European Medicines Agency are re-evaluating the safety of Invokana
After receiving reports of Invokana users experiencing serious side effects like heart attack, stroke, kidney failure, and ketoacidosis, both Health Canada and the European Medicines Agency launched their own investigations into the safety of the drug.
Rulings by either Health Canada or the European Medicines Agency could affect how the drug is allowed to be marketed in their respective countries.
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9 - Invokana has only been studied for a short time
The Food and Drug Administration (FDA) only just approved the sale and marketing of Invokana in March 2013.
Prior to its approval, Invokana was studied for only about three years and FDA experts asked to review the research data were concerned about this short period of clinical evaluation.
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8 - Invokana is under evaluation for links to heart attack and stroke
As required by the FDA, Janssen Pharmaceuticals and Research is conducting post-marketing studies to determine if there are links between taking the type 2 diabetes medication and facing an increased risk of heart attacks and stroke.
The post-marketing studies, known as CANVAS (CANagliflozin cardioVascular Assessment Study), came at the behest of the FDA experts who evaluated Invokana prior to approval for sale.
The Invokana CANVAS study is not expected to be completed until 2017.
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6 - Invokana was originally developed by a Japanese pharmaceutical company
Takeda Pharmaceuticals originally developed Invokana in the early 2000s before licensing the worldwide marketing rights to Janssen.
The Takeda Actos settlement is estimated to reach as high as $2.7 billion depending on the total number of claimants.
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4 - The Food and Drug Administration issued safety communication about Invokana
In May 2015, the FDA issued a Drug Safety Communication warning Invokana and other SGLT2 inhibitor users their type 2 diabetes medications could lead to serious health conditions.
Health conditions specifically named in the FDA’s Drug Safety Communication include ketoacidosis, a serious and potentially life threatening condition.
If left untreated, ketoacidosis may result in diabetic coma and even death.
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3 - One-third of experts asked by the Food and Drug Administration to review Invokana studies voted against its approval
In January 2013, two months before approving Invokana, the FDA asked experts on its Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to review Invokana clinical trials.
The FDA’s EMDAC voted ten to five to approve the sale and marketing of Invokana despite one-third of its members raising serious questions about the diabetes drug’s safety.
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2 - Medical journals question Invokana’s safety as it relates to kidney function
In May 2015, the Institute for Safe Medication Practices (ISMP) reported over 400 adverse events associated with taking Invokana.
The ISMP reports kidney injuries suffered by Invokana users included kidney failure, kidney stones, dehydration, hypersensitivity, and urinary tract infections.
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1 - If you or a loved one suffered a serious injury while taking Invokana, you may be entitled to substantial compens...
Experienced products liability attorney representing injured users of the diabetes drug Invokana who experienced serious side effects including ketoacidosis, kidney failure, heart attack, strokes, ...