Below, you will find the issues surrounding a possible recall or settlement involving Sodium Glucose Contransporter-2 (SGLT2) Inhibitor drugs and the serious side effects being reported by people prescribed drugs such as Invokana or other SGLT2 inhibitors.
May 18, 2016: Food and Drug Administration (FDA) releases a Drug Safety Announcement for patients taking Invokana, as an ongoing clinical trial found a potential increase in leg, foot, and toe amputations. The FDA is currently investigating the link between Invokana and amputations, and has plans to update consumers as they receive more information.
May 2015: FDA issues a warning about certain drugs used to treat Type 2 diabetes, specifically SGLT2 inhibitors, which are meant to remove excess glucose (blood sugar) through the urine. The FDA warning states that use of SGLT2 inhibitors, such as Invokana, can lead to ketoacidosis, kidney damage, and myocardial infarctions (heart attacks).
Below, is a chart listing the brand name medications that are currently under investigation by the FDA for invoking serious, sometimes deadly, side effects including heart attacks, kidney failure and ketoacidosis.
|Invokamet||Canagliflozin and Metformin|
|Xigduo XR||Dapagliflozin and Metformin extended-release|
|Glyxambi||Empagliflozin and Linagliptin|
Per the Invokana website, in small type at the bottom of the page, there are warnings about serious side effects of Invokana which state:
Possible Side Effects of INVOKANA®
INVOKANA® may cause serious side effects, including: kidney problems, a high amount of potassium in your blood (hyperkalemia), or low blood sugar (hypoglycemia). If you take INVOKANA® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA®.
Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery.
It is advisable to visit that website’s full disclosure about possible serious side effects of being prescribed Invokana.
Invokana and other SGLT2 inhibitors force the kidneys to process excess glucose, which may be why so many kidney problems have been reported by people prescribed Invokana. The Institute for Safe Medication Practices (ISMP) released a report in May, 2015 warning about adverse reactions being reported by patients prescribed Invokana. Among the reported symptoms, several involve kidney-related problems, including over 50 people suffering from kidney failure. Over 10 people developed kidney stones, 50 people in the study developed urinary tract infections.
Prior to approval by the FDA, clinical trials were conducted in 2013. Patients experienced increased onset of fungal infections, and studies in animals indicated that long-term use of the drug could lead to kidney damage, cancers, and bone abnormalities. Janssen, the manufacturer of Invokana, has strong warnings to avoid the medication if you have existing kidney problems or are on dialysis.
Myocardial infarction is the clinical term for a heart attack, and involves the blood flow being cut off from the heart, which in turn stops the flow of oxygen to the heart and causes damage to the heart muscle. The most commonly reported symptoms are pain and tightening in the chest. Discomfort can be felt in the left shoulder, arm, or back. Most heart attacks are caused by heart disease resulting from smoking, diabetes, poor diet, or a family history of heart disease.
Early reports from an ongoing comprehensive study of the side effects of Invokana have suggested a much higher incident rate of heart attacks among Invokana users.
Ketoacidosis is a medical condition whereby the body isn’t receiving enough glucose (blood sugar), so it begins burning fat for energy. The fat is broken down into acids. These acids appear in the blood and urine as ketones. As the ketones build up in the blood they can begin to poison the body. If left untreated, ketoacidosis can lead to coma or death. Diabetic ketoacidosis (DKA) is serious and can be fatal.
Because ketoacidosis is rare in Type 2 diabetics, it is important that any Type 2 diabetic that has been prescribed Invokana be familiar the signs and symptoms. DKA is your body’s way of letting you know that your blood sugar is out of control.
Initial Symptoms of DKA
More advanced symptoms of DKA
Medications are the subject of a drug recall all the time, primarily because of reports of adverse interactions or drug side effects. Unfortunately, even some doctors are not aware of the long term side effects of the drugs they prescribe. As reports surface, a drug may be voluntarily recalled by the manufacturer, or as in the case of Invokana, the FDA may issue a warning. Warnings from the FDA often become official recall notices. If you or a loved one has suffered harmful side effects as the result of being prescribed Invokana or any other harmful drug, you have the right to hold the manufacturer of that drug responsible for your injuries.
At the Stampfle Law Firm, our dedicated defective drug lawyers offer all of our clients superior legal advice and representation. Our firm has the resources to hire medical experts and the experience necessary to represent clients against large pharmaceutical companies. Due to our exceptional understanding of pharmaceutical litigation laws, our side effects attorneys have recovered millions of dollars on behalf of our seriously injured clients.
When you contact a Myrtle Beach South Carolina Injury Attorney at our firm to handle your drug side effects case, you get an expert eam of legal professionals. We have helped thousands of injury victims recover settlements for their injuries, losses, and pain & suffering.