Drug Safety Developments

EMA Warns that Some Diabetes Drugs Cause Increased Risk of Amputation

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A

 

Earlier today, February 10, 2017, the European Medicines Agency (EMA) released the findings of their Pharmacovigilance Risk Assessment Committee (PRAC) concerning the link between particular diabetes drugs and an increased risk of toe amputation.

These diabetes drugs are part of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of drugs, and are used to treat type 2 diabetes.  They are separated by their active ingredients: canagliflozin, dapagliflozin and empagliflozin.

Diabetes drugs that contain canagliflozin -- such as Invokana and Invokamet -- were the main subject drugs included in this study.  However, it was noted that similar diabetes drugs in the SGLT-2 class, such as Jardiance, Farxiga, Glyxambi, and Xigduo XR, could also have the same increased risk of amputation.  The article notes that studies are currently being conducted on the relationship between these other drugs, and further data is needed before they can be definitively associated with an increased risk of lower-limb amputations, or not.

It has been confirmed, however, that all of the drugs in the SGLT-2 class of drugs are associated with an increased risk of diabetic ketoacidosis (DKA), as discussed in my previous article, "Health Canada Warns About Link Between DKA & Popular Diabetes Drugs."

While those with diabetes that is poorly-controlled, or with pre-existing heart and blood vessel problems are already at an increased risk of infections and sores that can lead to amputations, Invokana and Invokamet can increase that risk even further.

The article released by the EMA provides the following information:

On the basis of the available data, the PRAC recommends that a warning on the risk of lower limb amputation (mostly affecting the toes) should be included in the prescribing information for these medicines, highlighting the importance of routine preventative foot care.

For canagliflozin, lower limb amputation should be listed as an uncommon side effect (occurring in between 1 and 10 patients in 1,000). Doctors should consider stopping treatment with canagliflozin if patients develop significant foot complications such as infection or skin ulcers.

The PRAC recommendation will now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP) for the adoption of EMA’s final opinion. Further details and advice for patients and healthcare professionals will be published at the time of the CHMP opinion.

Accordingly, we will continue to monitor the medical literature on the relationship between all SGLT-2 diabetes drugs and an increased risk of lower-limb amputations.

For more information on this topic, see my previous articles:

• All SGLT2 Inhibitors Now Investigated for Increased Risk of Amputation (7/11/16)
• Are Invokana & Invokamet Linked to Increased Risk of Toe Amputations? (4/18/16)

We are currently investigating amputation cases concerning these type 2 diabetes drugs, and encourage you to complete a free case evaluation if you or someone you know, has experienced lower-limb amputation(s) while using these drugs.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

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More Articles on this topic:

• Risk of Lower Limb Amputations Doubled with Invokana and Invokamet Use
• All SGLT2 Inhibitors Now Investigated for Increased Risk of Amputation
• Are Invokana & Invokamet Linked to Increased Risk of Toe Amputations?

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EMA Advises How to Reduce DKA Risk While Taking SGLT2 Inhibitors

 

Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.

 

Though a link between the sodium-glucose co-transporter 2 (SGLT2) inhibitors class of drugs and diabetic ketoacidosis (DKA) has been previously addressed, the European Medicines Agency (EMA) recently reviewed these type 2 diabetes medications, and gave recommendations to healthcare providers on how to diminish the risk of diabetic ketoacidosis (DKA) while taking them.  

For clarification purposes, some common SGLT2 inhibitors are Invokana, Invokamet / Vokanamet (Europe), Farxiga / Forxiga (Europe), Xigduo, Jardiance, and Synjardy, and the EMA defines diabetic ketoacidosis as "a serious complication of diabetes caused by low insulin levels."    

Some abnormalities have occurred in those diagnosed with DKA while taking SGLT2 inhibitors.  For example, some individuals presented with only slightly elevated blood glucose levels. 

Given that DKA does not always entail higher blood glucose levels, the EMA urges healthcare providers and those taking SGLT2 inhibitors to also watch for other common symptoms of DKA.  Such symptoms include "rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat."

Though rare, DKA can have life-threatening -- and even fatal -- consequences.  As such, the EMA warns those taking these drugs to cease immediately if they are diagnosed with DKA, unless another cause of DKA can be identified.

Additionally, the Drug Safety Update article "SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis" warns of various factors that "may predispose patients taking an SGLT2 inhibitor to DKA":

• a low beta cell function reserve (eg, patients with type 2 diabetes who have low C-peptide levels, latent autoimmune diabetes in adults [LADA], or a history of pancreatitis)
• conditions leading to restricted food intake or severe dehydration
• sudden reduction in insulin
• increased insulin requirements due to acute illness
• surgery
• alcohol abuse

At the present time, we will continue to monitor medical literature concerning the SGLT2 inhibitors class of drugs, and their relation to diabetic ketoacidosis.  Updates will be provided as available.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

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More articles on this topic:

• Health Canada Warns About Link Between DKA & Popular Diabetes Drugs
• Canagliflozin Also Causes DKA in Those With Type 1 Diabetes
• U.S. FDA warns on newer class of type 2 diabetes drugs

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