Drug Injury Watch

Invokana, Farxiga, Jardiance, Other SGLT2 Inhibitors Associated With Retinal Vein Occlusion

Increased Risk for This New Vision/Eyes Side Effect Highest in Elderly Patients and Chronic Kidney Disease Patients

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In June 2021 it was reported that Invokana, Farxiga, and Jardiance, as well as other drugs in the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class, are associated with an increased risk of retinal vein occlusion. This new SGLT2 inhibitors side effect was the subject of a presentation at the 81st Scientific Sessions of the American Diabetes Association which was based on the first study to examine the potential association of retinal vein occlusion with the use of SGLT2 inhibitors.

From this news report published on the PracticeUpdate website (free registration required), "ADA 2021: SGLT2 Inhibitors May Increase the Risk of Retinal Vein Occlusion", we get these details:

“SGLT2 inhibitors lower blood glucose levels by increasing urinary glucose excretion and can also reduce body weight and blood pressure,” wrote the authors in their study poster. “Retinal vein occlusion is a peripheral vascular occlusive disease that shares cardiovascular risk factors. As patients with type 2 diabetes have a markedly higher rate of retinal vein occlusion than those without, assessing the risk of retinal vein occlusion associated with the use of new drugs for diabetes is important.”....

In a subgroup analysis, significant interactions were evident with use SGLT2 inhibitors and risk of retinal vein occlusion concerning age ≥ 60 years (hazard ratio 1.53, 95% confidence interval 1.20–1.94, P =.0135) and estimated glomerular filtration rate < 60 mL/min/1.73 m2 (hazard ratio 3.13, 95% confidence interval 155–6.32, P = .0083). No significant interactions were evident for sex, age, body mass index, presence of comorbidities, multiple lifestyle factors, or use of other anti-diabetes agents.

“In a matched cohort study, we found that SGLT2 inhibitors were associated with a significantly increased risk of retinal vein occlusion. The elderly and patients with chronic kidney disease were at higher risk for retinal vein occlusion,” concluded the researchers in the poster.

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Invokana / Farxiga / Jardiance

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Of course, we will continue to monitor the medical literature for more about this new SGLT2 inhibitors side effect related to vision/eyes, retinal vein occlusion.

Previously, Invokana, Farxiga, and Jardiance -- as well as Invokamet, Xigduo, Glyxambi, Synjardy, Qtern, Steglatro, Steglujan, Segluromet, and other SGLT2 inhibitors -- have been associated with other side effects, or adverse drug reactions, such as Fournier’s gangrene and necrotizing fasciitis of the perineum. We have been investigating possible drug injury lawsuits against the responsible pharmaceutical companies for patients who were diagnosed with those serious side effects.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Fournier's Gangrene Is A Side Effect Of Farxiga, Invokana, Jardiance, And Other SGLT2 Inhibitor Diabetes Drugs -- Or Is It?

At The Recent American Diabetes Association (ADA) Scientific Sessions There Was An Expression Of Doubt About Warnings For This Association

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In August 2018 the FDA required a new warning about an increased risk of developing Fournier’s gangrene (also known as necrotizing fasciitis of the perineum) be added to the drug labels for all SGLT2 inhibitor diabetes drugs. That regulatory action was based on 12 cases of Fournier’s gangrene reported from March 2013 to May 2018.

Next, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued this Drug Safety Update, "SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum)" in February 2019.  This MHRA document included the following statement:

An [European Union (EU)] review has assessed reported cases of Fournier’s gangrene across the class of SGLT2 inhibitors. Although diabetes mellitus is a risk factor for the development of Fournier’s gangrene, some of the EU post-marketing reports were considered possibly to be related to the use of SGLT2 inhibitors. Fournier’s gangrene usually occurs almost exclusively in men. However, around a third of the EU cases reviewed were reported in women. We are also aware of rare occurrences of Fournier’s gangrene in patients on SGLT2 inhibitors in the USA (see FDA safety announcement).

Later, an FDA analysis article published in May 2019 by the medical journal Annals of Internal Medicine presented findings from a review of 55 cases reported to the FDA Adverse Event Reporting System (FAERS) through January 2019.  Our article "FDA: More Reports Of Diabetes Drugs Invokana, Jardiance, And Farxiga Being Associated With Fournier’s Gangrene" covered this development.

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Invokana / Farxiga / Jardiance

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But just last month there was an expression of doubt about whether, in fact, Fournier's gangrene is a side effect of Farxiga, Invokana, and Jardiance as well as other less popular SGLT2 inhibitor diabetes drugs.

From this July 18, 2019 article published online by Medscape, "Fournier Gangrene and Genitourinary Infections With SGLT2 Inhibitors: ADA 2019 Update", we get these details:

At the recent American Diabetes Association (ADA) Scientific Sessions, more details were presented on the adverse events in DECLARE-TIMI 58, the first trial of SGLT2 inhibitors completed after the FDA warnings on FG. The investigators planned to collect serious adverse events and any adverse events leading to drug discontinuation, but went back and did an in-depth check for necrotizing fascitis in light of the concerns.

They identified six cases of FG among study participants; five occurred in the placebo group (Table). Lawrence A. Leiter, MD, University of Toronto, Ontario, Canada, said in a press conference at ADA that on the basis of the DECLARE-TIMI 58 data, SGLT2 inhibitors do not seem to increase the risk and that FG is a diabetes-associated complication.

This Medscape article included a response to that contention by Susan Bersoff-Matcha, MD, of the FDA's Center for Drug Evaluation and Research, who said the DECLARE-TIMI 58 data are still under review by the FDA. She went on to comment:

At this time, our opinion regarding the association between SGLT2 inhibitor use and FG has not changed. We, however, note that the DECLARE-TIMI 58 study only evaluated patients using [Farxiga (dapagliflozin)] and may not be reflective for the SGLT2 inhibitor drug class [as a whole].

We will continue to watch for evidence that Fournier's gangrene is Farxiga side effect as well as Invokana, Jardiance, and other SGLT2 inhibitor diabetes drugs -- or that it is not a drug side effect of these medicines.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Newer Diabetes Drugs Side Effect: Fournier’s Gangrene, Serious Infection Of Genital Area

FDA Mandates Label Changes With New Warnings For Invokana, Farxiga, Jardiance, Other SGLT2 Inhibitors

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In late August 2018 the FDA warned doctors and patients that cases of Fournier’s gangrene, a rare but serious infection of the genitals and area around the genitals, have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. More specifically, this serious rare infection is called necrotizing fasciitis of the perineum.

Oral diabetes medicines included in this SGLT2 inhibitors drug class are Invokana, Farxiga, and Jardiance, as well as Invokamet, Xigduo, Glyxambi, Synjardy, Qtern, Steglatro, Steglujan, and Segluromet.

From this August 29, 2018 Drug Safety Communication, "FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes", we get the following details about this new safety issue for Invokana, Farxiga, Jardiance, and the other SGLT2 inhibitor diabetes drugs:

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Invokana / Farxiga / Jardiance

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Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum....

In the five years from March 2013 to May 2018, we identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor.... Although most cases of Fournier’s gangrene have previously been reported in men, our 12 cases included 7 men and 5 women. Fournier’s gangrene developed within several months of the patients starting an SGLT2 inhibitor and the drug was stopped in most cases. All 12 patients were hospitalized and required surgery. Some patients required multiple disfiguring surgeries, some developed complications, and one patient died. In comparison, only six cases of Fournier’s gangrene (all in men) were identified in review of other antidiabetic drug classes over a period of more than 30 years.

In the Additional Information for Patients part of that FDA document there is this important point:

• Seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly.

We have started investigating possible drug injury lawsuits for patients diagnosed with necrotizing fasciitis of the perineum, also referred to as Fournier’s gangrene, while using Invokana, Jardiance, Farxiga, or one of the other SGLT-2 inhibitor diabetes drugs.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)