While type 2 diabetes drugs are among the fastest-growing segment on the market, they’re not without risk of serious side effects. In just the past 5 years, studies have linked them to kidney disease, bladder cancer, pancreatitis and ketoacidosis.
So when data emerged this past June linking a class of diabetes drugs known as sodium-glucose co-transporter-2 (SGLT2) inhibitors to increased lower limb amputation risks, there was concern - but little surprise.
Study Shows Amputation Risks
SGLT2s include popular drugs like Farxiga, Jardiance and Invokana. They work by assisting the kidneys in reducing blood sugar.
The study published in June, known as CANVAS, followed more than 10,000 diabetes patients for eight years, many of whom had taken Invokana. The double-edged results showed that while Invokana may cut cardiovascular risks by around 14%, it can also double the risk of lower limb amputations.
Specifically, those over the age of 65 taking Invokana had a greater chance of developing lower limb infections, ulcers, bone fractures, restricted blood flow and gangrene.
EMA and FDA Issue Warnings Of Amputation Risks from SGLT2 Drugs
Upon news of the CANVAS study data, the European Medicines Agency reacted quickly by requiring new warnings on all SGLT2 drugs that they may increase the risk of lower limb amputations.
The U.S. FDA, however, only required new warnings to be included with the prescribing information for Invokana, since the data came from studies of that drug alone.
However, all parties agreed that more investigation was needed into the dangers of all SGLT2 drugs, given their growing use worldwide.
Yale Study Shows Risks May Only Lie with Invokana
Now, a follow up review of a recent landmark study by the Yale Diabetes Center has demonstrated that the increased amputation risks may not be present with all SGLT2 drugs, but merely with Invokana.
In 2015, researchers from Yale initially released data from the EMPA-REG OUTCOME, a study of more than 7,000 patients with diabetes that were given either a placebo or the SGLT2 drug Jardiance.
At the time, focus centered on the promising data showing the drug may decrease cardiovascular deaths by up to 38%. However, in the wake of the recent amputation risk scare among all SGLT2 drugs, doctors re-assessed the mountains of data.
What they found, according to a recent report by lead researcher Dr. Silvio Inzucchi, is that there is no evidence linking Jardiance with increased amputations.
Limitations of the Jardiance Study
In full disclosure, it is important to note that the original EMPA-REG study of Jardiance was funded entirely by Boehringer Ingelheim, the company that sells the drug.
It’s also very important to note that Dr. Inzucchi is a paid consultant for Boehringer Ingelheim. And, the original study didn’t look specifically at hospital admissions for amputations, but did track every admission for serious medical treatment while participants were taking the drug.
Therefore, the conclusion that Jardiance isn’t linked to amputations may or may not be tainted.
Further, no data has been submitted showing whether or not Farxiga, the third drug in the SGLT2 class, is linked to amputations.
Either way, the data seems to suggest that amputations may not be a class-wide problem of SGLT2 drugs, but instead a side effect associated only with Invokana.
Lawsuits Growing For Invokana Patients Suffering Amputations
At the present, hundreds of lawsuits have already been filed against the maker of Invokana for serious side effects including kidney disease and ketoacidosis.
To handle the growing number of cases, the Judicial Panel on Multidistrict Litigation last year consolidated all Invokana lawsuits to a centralized multidistrict litigation court to handle the upcoming trials or settlements.
As of December 2017, more than 950 cases had been filed in MDL 2570 for Invokana injuries, and the number keeps increasing.
Surprisingly, and despite the growing number of serious side effects, Invokana maker Johnson & Johnson has implemented plans to have the drug approved to millions of new patients for cardiovascular disease in addition to diabetes.
Lawyers are currently investigating and filing lawsuits on behalf of those who experienced limb or extremity amputation, ketoacidosis, or kidney disease after taking Invokana.
It costs nothing to talk with a lawyer and there is no fee to file a claim unless you receive an award. DrugNews works exclusively with lawyers that have handled thousands of Invokana and similar drug injury cases.
For more information, or to speak directly with a lawyer at no cost, contact DrugNews today.
Nainggolan, L. No Signal for Amputation With Empagliflozin in EMPA-REG. MedScape. (November 27, 2017). Retrieved from https://www.medscape.com/viewarticle/889164
JPML. Pending MDLs. (December 1, 2017). Retrieved from http://www.jpml.uscourts.gov/pending-mdls-0
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