Drug Injury Watch

Farxiga And Jardiance Are Associated With Twofold Increased Risk For Lower Limb Amputations

November 2018: The BMJ Medical Journal Publishes New SGLT2 Diabetes Drug Observational Study

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Diabetes drugs in the sodium-glucose cotransporter 2 (SGLT2) inhibitors class are associated with twice the risk for lower limb amputations relative to certain other diabetes medicines, according to a new observational study published by The BMJ medical journal in November 2018.

Noteworthy is that Farxiga (dapagliflozin) and Jardiance (empagliflozin) accounted for 99% of SGLT2 inhibitor use in this study which involved 2013–2016 data from Swedish and Danish registries.

However, in the US only a third SGLT2 inhibitor, Invokana (canagliflozin), has a drug label warning for increased amputation risks, and it is a so-called "Black-Box" warning pursuant to an FDA mandate issued in May 2017.

By comparison, the European Medicines Agency (EMA) warned about a potential increased risk of lower limb amputations (mostly affecting the toes) in patients taking any of the SGLT2 inhibitors, including Farxiga and Jardiance as well as Invokana,  in February 2017.

It is this BMJ article, "Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study", which reports about Farxiga and Jardiance being associated with a two-times increased risk for amputations of toes, feet, and legs. From the Abstract for this medical journal article:

Results  Use of SGLT2 inhibitors, as compared with [ glucagon-like peptide 1 (GLP1) receptor agonists], was associated with an increased risk of lower limb amputation (incidence rate 2.7 v 1.1 events per 1000 person years, hazard ratio 2.32, 95% confidence interval 1.37 to 3.91)....

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In more detail, from the Discussion part of this November 2018 medical journal article:

The twofold increase in risk of lower limb amputation associated with the use of SGLT2 inhibitors observed in our study is in line with the findings from the CANVAS Program, which randomised patients with high cardiovascular risk to [Invokana (canagliflozin)] or placebo. Importantly, our results were consistent in patients with and without cardiovascular disease and with and without peripheral arterial disease or previous amputation; the event rates, however, were substantially higher in the subgroups with such history. A pooled analysis of clinical trials of [Farxiga (dapagliflozin)] was underpowered to assess lower limb amputations, and no imbalance in this outcome in patients receiving [Jardiance (empagliflozin)] versus placebo was observed in the EMPA-REG OUTCOME trial. Whether the increase in lower limb amputations is a class effect for SGLT2 inhibitors, or specific to individual drugs, needs further study....   [Footnotes omitted.]

For some commentary on this recent BMJ medical journal article concerning Farxiga and Jardiance, we turn to this November 15, 2018 HealthDay News report, "Certain Diabetes Meds Tied to Higher Odds for Amputation":

[Dr. Kevin Pantalone, an endocrinologist with the Cleveland Clinic] and [Dr. David Lam, an assistant professor of medicine, endocrinology, diabetes and bone disease at the Icahn School of Medicine at Mount Sinai in New York City] said one potential way that SGLT2 inhibitors might increase amputation risk is due to the way they work in the body.

Many people who are diabetic have poor circulation in their legs and feet, and these drugs cause people to excrete more urine to lower their blood sugar, the doctors said.

"You could potentially get more dehydrated if your blood sugars are very elevated," Lam said. "Because of the decrease in blood volume, it's decreasing overall blood flow and that might be compromising someone who's already at risk for having poor blood circulation to their lower extremities. It could be making an existing problem worse."

The conflicting results between this observational study and previous clinical trials means doctors will have to take a patient-by-patient approach, Pantalone and Lam said.

We will continue to monitor the drug safety issue of lower limb amputations for patients using Farxiga and Jardiance, in particular, as well as watch for a possible new FDA warning about an increased risk of amputations covering all SGLT2 inhibitor diabetes drugs, not just Invokana.

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)

CoaguChek XS PT Test Strips: Roche Devices For Blood Thinner INR Measurement - Urgent FDA Recall November 2018

More Than 1 Million Packages Of Defective Devices Used To Check INR For Warfarin May Cause Serious Injuries Or Death

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In September 2018 Roche Diagnostics issued a voluntary recall of more than 1 million packages of the CoaguChek XS PT Test Strips that were sent out nationwide from January 2018 up to the date when Roche issued this CoaguChek recall.

On November 1, 2018, however, the severity and urgency of this CoaguChek INR test meter devices recall was increased when the FDA designated it a Class I recall. For medical devices, this is the most serious type of FDA recall, reserved for situations where use of the defective devices may cause serious injuries or deaths.

We get more of the basic facts from this FDA document, "Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results":

• Name and Version: CoaguChek XS PT Test Strips
• Lot numbers: [see full list on the CoaguChek FDA recall document]
• Models: CoaguChek XS PT Test 2x24 Strips, CoaguChek XS PT Test 6 Strips, CoaguChek XS Test 24 Tests USA
• Manufacturing and Distribution Dates: January 12, 2018 – October 29, 2018
• Devices Recalled in the U.S.: More than 1.1 million packages
• The lot number is printed on the test strip label, which is applied to the test strip box and the test strip vial.

As background, CoaguChek XS PT Test Strips are used with Roche INR Test Meters to monitor patient response to warfarin (also known by the brand names Coumadin and Jantoven), providing the test result in the form of the International Normalized Ratio, or INR. The INR is used by patients and physicians to determine if warfarin dosing is appropriate.

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In January 2018 Roche re-calibrated the CoaguChek XS PT Test Strips in to correspond to a newly released INR International Standard. According to the FDA, in the months following this re-calibration Roche Diagnostics has received reports of patients experiencing abnormally high or inaccurate INR test results when testing with CoaguChek strips.

The FDA CoaguChek XS PT Test Strips Class I recall announcement includes this serious message: "Use of affected products may increase the risk of serious adverse health consequences, including death." It goes on to provide this additional important information:

Patients with the following conditions are at especially high risk for serious events associated with inaccurate INR measurements:

• Mechanical heart valve
• Atrial fibrillation and high-risk CHA2DS2-VASc scores
• Recent thromboembolic events

For more about this recall of certain Roche Diagnostics test strip lots used with its CoaguChek test meter devices, see this November 1, 2018 FDA News Release, "FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin".

We are investigating possible legal compensation claims against the manufacturer Roche for patient injuries or deaths due to the use of these defective CoaguChek test devices.

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)

Amputations Side Effects: Invokana Only, Or Jardiance, Farxiga, And Other SGLT2 Inhibitors Diabetes Drugs, Too?

Increasing Degree Of Acknowledgement In Medical Literature That Toe, Foot, And Leg Amputations Are Drug-Class Side Effects

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

We have been following developments in the medical realm concerning the drug safety issue of whether the toes, feet, and legs amputations side effects associated with Invokana (canagliflozin) are found, also, with Jardiance (empagliflozin), Farxiga (dapagliflozin), and other diabetes medicines in the sodium-glucose co-transporter-2 (SGLT2) inhibitors class of drugs. 

There seems to be an increasing degree of acknowledgement in the medical literature that these lower limb amputations are drug-class side effects of SGLT2 inhibitor diabetes medicines such as Jardiance and Farxiga in addition to Invokana.

For example, from this recent Medscape news report, "Canagliflozin (Invokana) Gets FDA Nod for CV Protection" there is this summary-type statement:

As with other SGLT2 inhibitors, [Invokana (canagliflozin)] may increase the risk of lower-limb amputations. The FDA added a boxed warning to the [Invokana (canagliflozin)] label last year.   [Emphasis added]

For on overview of how and why there is an apparent elevated risk of below-knee lower extremity (BKLE) amputations for Jardiance as well as Farxiga and other SGLT2 inhibitors diabetes drugs, you can review one of our brief pieces about this topic on our Drug Injury Law site:

• Lower Limbs Amputations Are SGLT-2 Inhibitors Drug-Class Side Effects
• Increased Risks Of Lower-Limb Amputations For Farxiga And Jardiance
• Invokana, Jardiance, And Farxiga Have Increased Risks Of Amputations
• Jardiance – Lower Limb Amputations Drug Safety Issue Remains Uncertain

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Invokana / Farxiga / Jardiance

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And if you want some more in-depth information on lower limb amputations being side effects of Jardiance, Farxiga, and similar diabetes drugs, you can read one or more of these four articles published earlier here on Drug Injury Watch:

1. Amputations Are SGLT-2 Inhibitors Drug-Class Side Effects It Now Appears, According To New Medical Evidence 
2. Invokana / Jardiance / Farxiga: Increased Risks Of Lower-Limb Amputations Compared To Another Class Of Diabetes Drugs 
3. Some Newer Diabetes Drugs Linked To Lower Limb Amputations: "Significantly Increased Risk" 
4. Jardiance - Amputations Drug Safety Issue Remains Uncertain Due To Admitted "inherent limitations of... post hoc analyses"

Over the past year we have been investigating drug injury lawsuits for patients who have had lower extremity amputations (legs, feet, toes) while using Invokana, Jardiance, Farxiga, or one of the other SGLT-2 inhibitors.   And given the direction that the medical literature appears to being going in, we will continue to do so.

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)