Are you using an SGLT2 Inhibitor drug and experiencing serious side effects? If so, you may have grounds for a personal injury claim. Other patients are reporting serious issues after using these drugs.
Type 2 sodium-glucose co-transporter (SGLT2) inhibitors are newer drugs used to treat Type 2 diabetes.
Two of these drugs are also available in combination form with another antidiabetic medication, metformin.
About Type 2 Diabetes
Diabetes is a medical condition in which the body does not process sugar correctly. Over time, excessive glucose levels in the bloodstream may damage organs. The damaged organs may include the eyes, kidneys, and skin. These are resulting in blindness, kidney failure, and the necessity for amputation of the feet and legs.
Type 2 diabetes is the most common and affects up to 28 million Americans. It is often related to obesity and may contribute to a number of additional disease including hypertension, high cholesterol levels and cardiovascular death.
In normal people, insulin helps to transport glucose or sugar from the bloodstream into the cells, where it can be used as energy. Type 2 diabetics may not produce enough insulin, or the blood cells may have become resistant to insulin – leaving much of the sugar in the bloodstream.
Antidiabetic medication has traditionally worked by increasing the production of insulin. These drugs assist with increasing the body’s sensitivity to insulin or by preventing insulin from being absorbed in the intestines.
As newer medications, SGLT2 inhibitors antidiabetics work differently from other antidiabetic medications. Those patients who struggled with other medications were given these instead, but many are suffering serious SGLT2 side effects and filing lawsuits.
SLGT2 Inhibitor Actions
When the kidneys work normally in a non-diabetic patients, extra glucose in the bloodstream filters from the blood and is reabsorbed back into the bloodstream by the kidney “tubules” where it can be used as energy.
As type 2 diabetics have too much glucose in the blood, SGLT2 inhibitors prevent the kidneys from reabsorbing that glucose so that it is passed out of the body in the urine. SGLT2 inhibitors result in over 100 grams of sugar being excreted into the urine. This is the same as excreting over 400 calories, causing some people to lose weight.
All medications have side effects, most of which are mild to moderate. The SGLT2 inhibitors have a number of serious side effects that can even be life-threatening.
Common side effects of SGLT2 inhibitors include:
- Yeast infections including vaginal, vulvar and penile (banal) infections
- Urinary tract infection including bladder and kidney infections
- Intolerance to the sun
- Rash and itching, often from yeast infection on skin
- Fatigue or loss of energy
More severe side effects of SGLT2 inhibitors may warrant emergency medical action.
Diabetic ketoacidosis is caused by high levels of ketones in the bloodstream which are produced by the body when it is unable to use glucose in the cells. The ketones are a byproduct of fat metabolism and are acidic in nature. The disorder can quickly deteriorate and become life-threatening.
Symptoms of diabetic ketoacidosis or ketosis may include:
- Increased thirst and urination
- Excessive hunger
- Abdominal pain or nausea
- Fatigue, Weakness, Dizziness
- Shortness of breath, Sweating, Rapid heart beat
- “Fruity” odor to the breath
If the patient does not receive treatment, the following symptoms may occur:
- Confusion or extreme irritability
- Dizziness or Fainting
- Trouble breathing
If left untreated, diabetic ketoacidosis is life-threatening.
Unfortunately, many Type 2 diabetics will not recognize the symptoms and the original prescribing information and patient instructions did not list diabetic ketoacidosis as a concern.
odium-glucose cotransporter 2 (SGLT2) inhibitors are a new medicine that can be prescribed to help treat type 2 diabetes. The SGLT2 inhibitors help to remove excess glucose in the blood through the urine; this allows for the balancing of the glucose and insulin levels in the body. However, there have been cases reported of these SGLT2 inhibitors causing a sickness called diabetic ketoacidosis.
Ketoacidosis is a health complication that occurs when there is excess acid in the body. This happens when your body is not getting enough glucose to use for energy; if the body does not have enough glucose, it creates ketones to compensate. When there are too many ketones in your blood, it becomes acidic. This acidity is poisonous to your body and causes the ketoacidosis. Some of the symptoms of ketoacidosis include high blood sugar, very dry mouth, dry, or flushed skin, constant tiredness, nausea, vomiting, confusion, and difficulty breathing. This is usually related to type 1 diabetes, but it has been shown to occur in type 2 diabetics who have been using SGLT2 inhibitors.
Studies link SGLT2 inhibitors to ketoacidosis
At this point in time, there are investigations being made by the Food and Drug Administration (FDA) to determine the safety of using SGLT2 inhibitors to treat type 2 diabetes. There have been at least twenty reported cases of ketoacidosis in type 2 diabetics who have used one of several SGLT2 inhibitor drugs.
As the SGLT2 inhibitors are being investigated by the FDA, many individuals are coming forward with claims that the drug caused their health problems. These individuals have filed both individual lawsuits and have begun a class action lawsuit that includes all of the SGLT2 inhibitor drugs thought to cause the ketoacidosis.
SGLT2 Inhibitor Kidney Failure
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are new in the world of medicine. They are part of a class of agents that are used in the lowering of glucose levels of individuals who have type 2 diabetes. They work in the kidneys and in the blood to help balance the glucose levels that are in the body. The excess glucose and calories are drained from the body through the urine to maintain a healthy balance.
Since the SGLT2 inhibitors work through the kidneys, it makes sense that they will be affected by whatever side effects take place. One of several noted side effects of using SGLT2 inhibitors includes dehydration. When the body becomes dehydrated, the kidneys are unable to do their job as they try to filter the fluids that travel through the body. If the kidneys are unable to do their job, they will start to fail which can lead to further complications in the body. Some symptoms of acute kidney failure include edema in the arms and legs, tiredness, confusion, and a sense of feeling sick.
If you are taking an SGLT2 inhibitor and are suffering any of the noted symptoms, contact your physician immediately to determine a course of action. The doctor will be able to help you determine the extent of your difficulties and create a treatment plan that will get you back on your feet and feeling better in no time.
Studies link SGLT2 inhibitors to kidney failure
Currently there are only investigations into the effects that sodium-glucose cotransporter 2 (SGLT2) inhibitors have on individuals with type 2 diabetes. It is a relatively new drug, only being around for a couple years, and major side effects are just now being tied back to it. The Food and Drug Administration (FDA) stated in May of 2015 that they would be investigating this class of drugs to determine whether they are safe for the health of potential patients.
SGLT2 inhibitors have not been tied to as many cases involving kidney failure as they have been tied to cases of ketoacidosis, though kidney failure has proven to be a complication of untreated ketoacidosis. As the investigations continue, there may be further developments in the ties relating kidney failure and the use of SGLT2 inhibitors.
Lawsuits filed against SGLT2 inhibitor manufacturers
There have been a number of lawsuits filed against the manufacturers of sodium-glucose cotransporter 2 (SGLT2) inhibitors though the outcomes of these suits have yet to be determined. The FDA has started their investigations based on the identification of twenty cases tying SGLT2 inhibitors to the diagnosis of ketoacidosis. Though kidney failure is not the main purpose of these lawsuits, the FDA will be thoroughly investigating the drugs to determine their safety for the individuals who might use the drug for glucose level regulation purposes.
If you have suffered any major complications after using an SGLT2 inhibitor, contact your physician for advice and medical attention. If the complications you suffer have been a result of the SGLT2 inhibitor you have been using, you may have reason to file a lawsuit of your own.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
Other Serious Side Effects
In addition, the medical data company, IMS has identified hundreds of additional serious adverse events that occurred in patients who took the newer SGLT2 inhibitor antidiabetic medications. The newer diabetic medications may also cause:
- Low blood pressure
- Changes in laboratory blood levels of potassium, cholesterol, hemoglobin and others
- Decreased kidney function
- Allergic reactions
Data shared in early 2017 by the European Medicines Agency found a high risk of toe amputation for those individuals using SGLT2 inhibitors.
In January, 2017, research was published in Diabetes Care showing that patients taking SGLT2 inhibitors may suffer the risk of renal injury.
Some medical professionals, including several FDA advisory committee members have expressed concern about an increased risk of heart attack and companies have been ordered to complete additional safety studies of the effects on the heart, bones, and liver and to look into the risk of cancer and pregnancy risk.
Public Citizen has also objected to advertising regarding the SGLT2 medications stating that “reduced blood pressure” as claimed by the medication’s marketing material is not a benefit, but a potentially harmful side effect as described in the literature.
They have also objected to the non-approved claim that “some” patients may lose weight on these medications as the notification often appears close to the approved indications which the group feels may be confusing and cause some to believe the medication is approved for use as a weight loss agent. Public Citizen has all three medications on its “Do Not Use” list on its website.
FDA Reactions to SGLT2 Inhibitor Side Effects and Risks in 2015 and Beyond
In May 2015, the FDA issued a warning letter regarding the risk of diabetic ketoacidosis, citing 20 serious adverse events reports the agency had received. Prescribing information for the medications has listed a “contraindication” (reason against use) for patients with DKA but literature contains no clear warning about the risk.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.