Injury caused by antidiabetic medications can result in a need for expensive medical treatments and hospitalizations. They can also require the need for long-term treatments, result in permanent disability and may even result in death.
The SGLT2 inhibitors are the newest class of antidiabetics used for Type 2 diabetes, but after only two years of use, have already been shown responsible for a number of serious adverse events including at least 20 cases of Diabetic Ketoacidosis, a life-threatening condition. A Japanese report also indicates that at least 10 patients may have died due to use of the SGLT2 medications.
Farxiga and Invokana Lawsuits
The class of antidiabetic medications known as type 2 sodium-glucose co-transporter (SGLT2) inhibitors include the medications:
In the recent past, thousands of lawsuits have been filed and settled for newer antidiabetic medications which have caused medical injury. These patients may be eligible for compensation for those medical costs, lost wages and pain and suffering caused by the medication. Families whose loved ones have died after using antidiabetic medications may be eligible for wrongful death compensation.
It is not yet known how many type 2 diabetic patients have been or may be injured by the SGLT2 inhibitors but data indicates that thousands of serious adverse events, including diabetic ketoacidosis, may be expected. Other antidiabetic lawsuits have been filed for claims such as:
- Manufacture and marketing of a defective or dangerous drug
- Failure to adequately warn the public and health care profession about drug risks
- Concealment of known drug risks
- Improper or illegal marketing activities
Each suspected occurrence of medical injury that may be related to the use of a drug must be considered independently. The circumstances for each case are different from others, but in other antidiabetic cases, patients or family members have been successful at receiving compensation for damages. Despite a history of success for thousands of patients, there is no guarantee of a settlement award as each case is unique and must be evaluated by an experienced attorney.
The first SGLT2 medication to be consider for approval was Farxiga. The Food and Drug Administration (FDA) initially denied the application in 2012, due to concerns about the drug’s effects on the liver. In March of 2013, Invokana was approved but five out of the 15 advisory panel members had voted against approval due to a potential for increased heart attack.
After additional study, Farxiga was approved in January of 2014 and the last member of the class, followed in August of 2014 even though reports of serious adverse events including diabetic ketoacidosis had already been received by the FDA.
Prior to Invokana’s approval, a consumer advocacy group, Public Citizen had expressed extreme objection to the new medications, stating that adequate safety information was not available and that the situation was concerning as other “new” antidiabetic classes had been shown to cause serious harm. Public Citizen has placed members of the SGLT2 class on its “Do Not Use” website list.
The same group has also objected to marketing used for the SGLT2 inhibitors which state “advantages” of the drug including “reduced blood pressure” and the possibility of weight loss. Public Citizen has stated that “hypotension” (low blood pressure) is a listed side effect and not a benefit and that advertising a weight loss potential close to the “approved use” of the treatment of Type 2 diabetes may lead some to believe the medication is for weight loss.
The FDA issued a warning notification to health care professionals in May 2015, regarding the diabetic ketoacidosis risk. This letter cited the 20 ketoacidosis reports the agency received but IMS, a healthcare data collection company, has identified hundreds of additional serious adverse events that may have occurred due to Invokana, Farxiga.
None of the literature originally included diabetic ketoacidosis as a serious risk of the medications. Hundreds of thousands of prescriptions are filled for Invokana, Farxiga and each month.
Diabetic ketoacidosis is caused by the body’s inability to use glucose as energy. When the cells cannot obtain enough glucose, fat stores must be used. Ketones, a highly acidic by product of fat metabolism, build up in the bloodstream, creating a dangerous medical condition which can quickly become life-threatening.
Unfortunately, most Type 2 diabetics have never experienced ketosis and will not easily recognize the symptoms. Any symptom of Diabetic Ketosis warrants immediate medical attention.
Symptoms of diabetic Ketoacidosis can include:
- Excessive thirst and hunger
- Excessive urination
- Gastrointestinal disturbance including pain and nausea
- Weakness, Fatigue and Dizziness
- Irritability, Sweating and Rapid Heartbeat
- Shortness of Breath with “Fruity” odor
If the condition is not treated immediately, symptoms may become worse including:
- Confusion and extreme irritability
- Dizziness and fainting
- Difficulty Breathing
If left untreated, the brain may swell and the condition will become life-threatening.
About Type 2 Diabetes and Treatments
Type 2 Diabetes is a disease that affects over 28 million Americans. Type 2 diabetics lack the ability to correctly move sugar or glucose from the blood stream where it can be used as energy. This is because the insulin that is required to help move the glucose is either deficient in amount or the body has become resistant to it.
Over time, high glucose levels in the blood may cause permanent damage including blindness, kidney failure and the need for amputation as the blood system is destroyed by sugar. Type 2 diabetes may also contribute to cardiovascular disease and other medical conditions.
Most antidiabetic medications work by increasing the body’s supply of insulin or by making the cells more sensitive to it. The newer SGLT2 inhibitors, sometimes called “gliflozins” due to the generic names (canagliflozin, dapagliflozin, and empagliflozin), work differently and were designed to help patients who did not respond adequately to other medications.
SGLT2 inhibitors block a chemical (SGLT2) which allows the kidneys to reabsorb normally secreted glucose back into the bloodstream so that it may be conserved. If the SGLT2 enzyme is blocked, the extra sugar will be excreted in the urine, lowering the blood sugar. Unfortunately, some patients taking Invokana or Farxiga.
Every medication may cause side effects. Most of the SGLT2 inhibitor side effects are mild to moderate but others may be more severe.
Common side effects may include:
- Yeast infections of the genital area in both men and women
- Urinary tract infections
- Photosensitivity reactions (sun intolerance)
- Loss of energy
More severe side effects may include:
- Hypotension (low blood pressure)
- Laboratory value changes (high potassium cholesterol, hemoglobin)
- Decreases in kidney function
- Other allergic reactions
Some of these effects may be medically important and may warrant medical treatment. Manufacturers of the medications have also been ordered by the FDA to conduct additional safety studies to examine effects on the heart, bones, liver, and the risk of cancer and pregnancy effects.