The Food and Drug Administration recently released an official warning to doctors and patients of a significant risk of severe genital infection, Necrotizing Fasciitis of the Perineum, or Fournier’s Gangrene.
This is a serious condition that requires immediate attention.
Symptoms may include tenderness, redness, or swelling of the genitals and a high fever. Most patients suffering from this condition would have needed treatment with broad-spectrum antibiotics and possibly had surgical debridement.
If you or someone you know has symptoms of this condition, please contact us immediately about making a claim and getting to a doctor for treatment.
*SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. These medications include Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Invokamet XR (canagliflozin and metformin extended-release), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin extended-release), Qtern (dapagliflozin and saxagliptin), Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin), Synjardy (empagliflozin and metformin), Synjardy XR (empagliflozin and metformin extended-release), Steglatro (ertugliflozin), Segluromet (ertugliflozin and metformin), and Steglujan (ertugliflozin and sitagliptin).
FDA Reports “Double Risk” of Amputation in Diabetics on Invokana Medication
Recently the FDA issued a black box warning for Invokana after data from a recent study was analyzed and showed that type 2 diabetes patients on the medication Invokana were twice as likely to suffer from lower extremity complications leading to a toe amputation, foot amputation and even leg amputation.
The data was collected through the adverse side effect reporting system that the Food and Drug Administration uses to collect drug and medical device related injuries that can occur. The recent findings that were published online consisted of 66 reports of amputations, where 57 of the 66 were linked to Janssen’s type 2 diabetes drug Invokana.
In May 2017, after the FDA issued the warning to the label of Invokana and other brand-named medications containing canagliflozin, hundreds of Invokana amputation lawsuits began being filed claiming that Janssen failed to warn patients and doctors that Invokana significantly increased the risk for amputations when compared with a placebo. When examining the other SGLT2 medications that similarly treat type 2 diabetes known as Jardiance (empagliflozin) and Farxiga (dapagliflozin), the FDA did not discover the same amputation risk. These medications then do not contain the same warning label as Invokana and Invokamet.
The FDA reports that patients that were reporting adverse side effects linked to Invokana including amputations of toes or feet were found to have an average age of about 60 years, they were on the medication for an average of 1 and ½ years, and most were men. 11% of the patients suffered from diabetic foot syndrome, which includes ischemia, neuropathy, deformity, wounds, infections, and/or previous amputations.
Other injury events associated with amputees on the drug Invokana include necrosis and gangrene. The most common amputations were toe or partial toe amputations. There were, however, 13 above-ankle foot amputations, 2 multiple amputations, and 1 hand amputation. Three of the amputees died after the surgery.
The frequency of an amputation occurring while on Invokana or Invokamet is 34 in every 10,000 patients.
The FDA states that their analysis does in fact confirm that canagliflozin (Invokana and Invokamet) may increase the risk of amputation in type 2 diabetes patients, while Jardiance and Farxiga are off the hook for now.
What diabetics are not being clearly told, however, is how to identify the actual side effects and injuries that lead up to the amputation event that Invokana and Invokamet are now linked to. An amputation of lower extremities including toes, feet, lower legs and even full legs is clearly the treatment of the injury, not the injury itself. In order for diabetes patients who are taking the SGLT2 inhibitor medication to control their blood sugar to prevent their lower limbs from dying and eventually requiring an amputation, they need to understand that if they are experiencing any of the following symptoms associated with a loss of circulation to their toes, they should immediately contact a physician:
Tingling or “Pins and Needles”
Discoloration or greying of skin
Pain or Aching
These symptoms could be a sign that the extremities are not receiving sufficient blood flow and may be in danger of serious injury. If ignored and left untreated, these symptoms can lead to:
Diabetic foot syndrome
Once an Invokana patient is diagnosed with gangrene in a limb, there is generally little that can be done to save the body part. Serious cases of gangrene can spread and cause larger parts of a patient’s limb to die so many patients have no choice than to opt for an amputation to prevent further harm to their bodies.
With the FDA’s recent demand that manufacturers of Invokana and Invokamet add a clear “black box” warning label to the packaging of the medication advising patients of a serious “double risk” of amputation, it is clear that enough evidence exists that patients need to heed the warning.
If you have taken SGLT2 inhibitors such as Invokana or Invokamet for diabetes and are suffering from any symptoms, please contact us immediately for help.
Contact Schmidt National Law Group today for a free case evaluation by calling 1-800-631-5656 or use the form at the bottom of this article.
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