A new class of diabetes medications known as Sodium-glucose co-transporter 2 (SGLT2) inhibitors have sparked concerns over safety because of potential side effects. The drugs, in conjunction with regular exercise and a proper diet, have been shown to help improve blood sugar levels in patients with type 2 diabetes, but the FDA has informed consumers that SGLT2 inhibitors may lead to dangerously high levels of blood acids (a condition known as ketoacidosis), which in some cases can require hospitalization.
SGLT2 inhibitors include Invokana (canagliflozin); Farxiga (dapagliflozin), Jardiance (empagliflozin), and other medications formulated with combinations of these active ingredients.
On the heels of the May 2015 FDA safety communication about the potential link between ketoacidosis and SGLT2 inhibitors, the national dangerous drug lawyers at Eisbrouch Marsh are reviewing cases to determine if patients are eligible for compensation from drug manufacturers. Potential defendants include Janssen Pharmaceuticals (a unit of Johnson & Johnson), AstraZeneca, Eli Lilly and Boehringer Ingelheim.
The FDA safety communication also references Invokamet, Glyxambi and Xigduo XR – combination diabetes treatments that include an SGLT2 component.
Patients taking any of these glycemic control medications should note that each state imposes time limits on when a personal injury claim must be filed. If Farxiga, Jardiance or Invokana lawsuits are not brought against the manufacturers before the statute of limitations expires, victims may lose the right to seek damages for their injuries and economic losses.
FDA Weighs In on SGLT2 Inhibitors and Ketoacidosis
Based on 20 reported cases of diabetic ketoacidosis (DKA) in patients taking SGLT2 inhibitors, the FDA advises diabetics to be on high alert for the following symptoms, and to seek immediate medical attention in the presence of:
- Labored breathing
- Abdominal pain
- Unusual fatigue
The FDA cited their Adverse Event Reporting System (FAERS) database, stating that all 20 SGLT2 patients required hospitalization or emergency room services to treat ketoacidosis, which can lead to coma and even death. The agency also cautions of other adverse side effects associated with Jardiance, Farxiga and Invokana, including kidney problems, dehydration and low blood sugar.
Financial recovery may be available through the courts for patients who suffered serious injuries or death from diabetic ketoacidosis after taking SGLT2 inhibitors as prescribed by their physicians. A successful defective product lawsuit may recoup damages if it’s found that drug makers failed to adequately warn patients and their doctors of the increased risks of ketoacidosis and subsequent complications such as coma, heart attack, kidney failure and death.
European Medicines Agency Encourages Invokana Monitoring
In light of increasing reports of diabetic ketoacidosis associated with SGLT2 inhibitors, the European Medicines Agency (EMA) issued new recommendations to help risk reduce among patients living in the EU. On February 12, 2016, the agency published a press release that cautioned patients who were taking diabetes drugs Invokana, Farxiga or Jardiance to be aware of early ketoacidosis symptoms such as confusion, rapid breathing and excessive thirst. Patients are encouraged to contact their doctors immediately, and once a diagnosis has been confirmed, stop treatment with SGLT2 inhibitors. The EMA warned that atypical presentation of diabetic ketoacidosis may delay a diagnosis and life-saving treatment. Health care providers should be alert to the risks of ketoacidosis in patients taking Invokana, even if their blood glucose levels are not abnormally high.
In addition, the Pharmacovigilance Risk Assessment Committee (PRAC) has suggested temporarily stopping the use of SGLT2 inhibitors in patients who are hospitalized for surgery or a serious illness.
Side Effects of Ketoacidosis
Diabetic ketoacidosis occurs from a lack of insulin, forcing the body to begin burning fatty tissue and muscle for energy, which in turn releases acidic ketones into the bloodstream. This chemical imbalance is a life-threatening metabolic state marked by hyperglycemia and ketonuria. If prompt measures aren’t taken to reverse the acid levels, ketoacidosis can cause brain swelling, diabetic coma and death.
In addition to ketoacidosis risks, the Institute for Safe Medication Practices (ISMP) has logged adverse reactions tied to Invokana, including:
- Renal failure
- Severe dehydration
- Urinary tract infections
- Kidney stones
- Drastic weight loss
- Skin rashes
- Allergic responses
- Swelling of the lips, tongue and throat
- Increased risk of fungal infections
The FDA has received adverse event reports regarding ketoacidosis in patients taking SGLT2 inhibitors, sparking an ongoing investigation into the safety of this class of drugs.
In the wake of this new information, diabetics being treated with Invokamet, Glyxambi , Xigduo XR or any SGLT2 inhibitor are encouraged to carefully monitor their health for early signs of ketoacidosis and contact the drug injury lawyers at Eisbrouch Marsh for more information regarding their legal options.
Invokana and Amputation Risk
Invokana has been linked to an increased risk of amputation of the leg, foot and toes. When the evidence of this risk was still preliminary, the FDA issued a warning. That was May, 2016. Soon after, the results were finalized. They showed that people taking Invokana had amputations about twice as often as people who were taking a placebo. These results came from two clinical trials.
In May, 2017, the FDA issued a more severe warning; in fact, it's the most serious warning they have: a black box on the product's label, which contains information about the risk of amputation. This risk is now featured prominently.
While the black box warning is a good thing, the fact remains that many people were taking Invokana previously without being properly informed of the risk. Now, physicians are urged to screen their patients for factors that already place them at high-risk for amputation, before recommending treatment with Invokana. For people already taking Invokana, while you should never stop taking a drug without talking to your doctor, you should be on the lookout for these symptoms:
- New pain
- Infection of the legs or feet
- Ulcers and sores
These symptoms and any other new symptoms should be reported to your doctor right away. They will determine if it is a complication related to Invokana.
At Eisbrouch Marsh, we want to hear from you if you have had an amputation and were taking Invokana at the time. You may be entitled to compensation, and our experienced attorneys can help you seek justice. We have been handling legal issues like these for more than 30 years.
Who Is Eligible to File a SLGT2 Lawsuit?
Legal action may be warranted for patients who experienced any of the following while taking an SGLT2 inhibitor:
- Kidney failure
- Myocardial infarction (heart attack)
Attorneys who specialize in dangerous drug claims against multi-national pharmaceutical manufacturers are the most qualified to determine whether patients have a viable lawsuit. Eisbrouch Marsh is on the forefront of major litigation against Big Pharma, securing millions of dollars on behalf of our clients. Potential SLGT2 ketoacidosis lawsuits will seek to prove that the drugs were sold with design and/or manufacturing defects and sold without sufficient warnings of adverse side effects.
Compensation Available to Plaintiffs
Product liability litigation can hold drug makers accountable for designing, manufacturing and selling a dangerous product that has the potential to cause injury or death when used for its intended purpose.
Claimants who have suffered injury after taking Invokana, Farxiga or Jardiance may be entitled to compensation to account for:
- Medical costs (past, present and future)
- Lost income
- Reduced earning capacity
- Pain and suffering
- Possible punitive damage award
How Eisbrouch Marsh Can Help
If it is found that drug manufacturers failed to conduct sufficient pre-market studies, warn about health risks or misrepresented the safety of their SGLT2 inhibitors, defendants may be forced to pay substantial monetary damages to plaintiffs. As an example, our firm recently procured a $7 million verdict on behalf of a client who developed pulmonary hypertension after taking the once popular diet drug Fen-Phen.
Put our experience, resources and legal savvy to work for you and contact us today for a no-cost legal consultation. To learn more about pursuing an Invokana lawsuit or other claim based on SGLT2 inhibitor injuries, call 201-342-5545 to speak with the veteran personal injury lawyers at Eisbrouch Marsh.
- Reuters, FDA warns on newer class of type 2 diabetes drugs http://www.reuters.com/article/us-fda-diabetes/fda-warns-on-newer-class-of-type-2-diabetes-drugs-idUSKBN0O01P520150515
- Institute for Safe Medication Practices, Unanswered Questions about Canagliflozin (INVOKANA) http://www.ismp.org/QuarterWatch/pdfs/2014Q2.pdf
- Mayo Clinic, Diabetic ketoacidosis http://www.mayoclinic.org/diseases-conditions/diabetic-ketoacidosis/basics/definition/con-20026470
- European Medicines Agency, SGLT2 Inhibitors: PRAC Makes Recommendations to Minimise Risk of Diabetic Ketoacidosis http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/02/news_detail_002470.jsp&mid=WC0b01ac058004d5c1