Drug Safety Developments

Do the Risks Outweigh the Benefits of DPP-4 Inhibitors Diabetes Drugs?

 

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

 

DPP-4 Diabetes Drugs

One of the popular classes of drugs for type 2 diabetes consists of dipeptidyl peptidase-4 (DPP-4) inhibitors.

This DPP-4 inhibitors class comprises the following drugs:

• Onglyza
• Kombiglyze XR
• Nesina
• Kazano
• Oseni
• Glyxambi
• Janumet (XR)
• Januvia
• Jentadueto
• Tradjenta
• Qtern

Based on various studies and patient reports, these drugs have been associated with the following side effects:

• Heart Failure
• Kidney Failure / Renal Failure
• Kidney Problems
• Decreased Renal Function 
• Cerebral Infarction / CVA / Stroke
• Myocardial Infarction (MI) / Heart Attack
• Acute Pancreatitis
• Severe Joint
• Inflammatory Bowel Disease (IBD)
• Ulcerative Colitis
• Crohn's Disease
• Rhabdomyolysis

 

Risk/Benefit Analysis

In my last article, I discussed the findings of a recent study conducted on three types of diabetes drugs: sodium-glucose cotransporter (SGLT-2) inhibitors, dipeptidyl peptidase (DPP-4) inhibitors, and incretin mimetics--also referred to as glucagon-like peptide (GLP-1) agonists.

Researchers found that all three classes of drugs were effective in lowering blood sugar levels among type 2 diabetes patients.  However, only two of the classes of diabetes drugs--SGLT-2 inhibitors and incretin mimetics--were shown to reduce the risk of death.  Furthermore, DPP-4 inhibitors were no more effective at reducing the risk than a placebo or no treatment at all.

This finding is particularly alarming given that type 2 diabetes is associated with higher risk of death due to heart attacks or strokes. 

In light of this information about the risks of DPP-4 diabetes drugs, one must wonder if other classes of type 2 diabetes drugs--which help reduce the risk of death--would be a better alternative.  Otherwise put, taking DPP-4 diabetes drugs may not be worth the risks that accompany them.

 

Current Lawsuits

In April 2016, the FDA issued a Drug Safety Communication that warned of the increased risk of heart failure in patients taking Onglyza, Kombiglyze XR, Nesina, Kazano, and Oseni.

Following that announcement, almost one hundred lawsuits were filed on behalf of patients taking Onglyza and Kombiglyze XR.  These cases have been compiled in a multi-district litigation (MDL) in Kentucky and are currently pending.

If you, or someone you know, have experienced any of the aforementioned side effects as a result of taking a DPP-4 inhibitor diabetes drug, we encourage you to visit our website for more information and complete a free case evaluation.

 

 

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

Only Two out of Three Classes of Diabetes Drugs Help Reduce the Risk of Death

 

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

 

Class Comparisons

Three popular types of diabetes drugs include sodium-glucose cotransporter (SGLT-2) inhibitors, dipeptidyl peptidase (DPP-4) inhibitors, and incretin mimetics (also referred to as glucagon-like peptide (GLP-1) agonists).

The following table provides a list of some of these types of drugs:

SGLT-2 Inhibitors	SGLT-2 / DPP-4 Inhibitors	DPP-4 Inhibitors / Incretin Mimetics	Incretin Mimetics
Invokana	Glyxambi	Onglyza	Byetta
Invokamet (XR)	Qtern	Januvia	Bydureon
Farxiga		Janumet (XR)	Victoza
Xigduo XR		Kazano	Juvisync
Jardiance		Oseni
Synjardy (XR)		Tradjenta
Steglatro		Jentadueto
Steglujan		Nesina
Segluromet		Kombiglyze XR

 

Study Results

A recent study compared these three types of diabetes drugs in order to determine their effect on "all-cause mortality" in patients with type 2 diabetes.  While all three classes lowered blood sugar levels, only two reduced the risk of death.  

The researchers found the use of SGLT-2 inhibitors and incretin mimetics was associated with lower mortality rates than DPP-4 inhibitors.  More specifically, SGLT-2 inhibitors were associated with a 21% reduction in cardiovascular-related death, and incretin mimetics were associated with a 15% reduction.

However, DPP-4 inhibitors did not reduce the risk of death when compared to a placebo or no treatment at all.

One of the researchers acknowledged that further studies are needed to confirm their findings, and tracking participants for a longer period of time would be beneficial.

 

Side Effects

While the study did not aim to identify any particular harmful side effects directly caused by the drugs, numerous side effects have been associated with these classes of drugs in other studies.  As such, one must wonder how the benefits of these drugs weigh against their potentially-fatal side effects.

For example, users of SGLT-2 inhibitors have experienced the following side effects:

• Diabetic Ketoacidosis (DKA)
• Ketoacidosis
• Ketosis
• Leg Amputation
• Foot or Toe(s) Amputation
• Acute Kidney Injury

• Kidney Failure / Renal Failure
• Kidney Damage
• Pyelonephritis (kidney infection)
• Urosepsis (blood infection)
• Urinary Tract Infection (UTI)
• Bladder Cancer

As for DPP-4 inhibitors, these side effects have been observed:

• Heart Failure
• Kidney Failure / Renal Failure
• Kidney Problems
• Decreased Renal Function 
• Cerebral Infarction / CVA / Stroke
• Myocardial Infarction (MI) / Heart Attack

• Acute Pancreatitis
• Severe Joint Pain
• Inflammatory Bowel Disease (IBD)
• Ulcerative Colitis
• Crohn's Disease
• Rhabdomyolysis

Lastly, incretin mimetics carry a potential risk of pancreatic cancer.

Going forward, we will continue to monitor the medical literature concerning the side effects associated with these three classes of diabetes drugs.

In the meantime, we encourage you to fill out one of our free case evaluations concerning SGLT-2 inhibitors, DPP-4 inhibitors, and incretin mimetics.

 

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

Type 2 Diabetes Drugs Linked to Severe Joint Pain

 

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

 

Health Canada recently warned about the risk of severe, debilitating joint pain as a result of taking type 2 diabetes medications called dipeptidylpeptidase-4 (DPP-4) inhibitors.  

This DPP-4 inhibitors class of drugs includes the following:

• Onglyza
• Kombiglyze XR
• Nesina
• Kazano
• Oseni
• Glyxambi
• Janumet (XR)
• Januvia
• Jentadueto
• Tradjenta
• Qtern

The FDA also issued a Drug Safety Communication in August of 2015 concerning the association of DPP-4 inhibitors and severe joint pain.  They soon added the following warning to the labels for these drugs:

Severe and Disabling Arthralgia

There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication. A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible cause for severe joint pain and discontinue drug if appropriate.

The FDA's warning and subsequent label change concerning DPP-4 inhibitors sparked an extensive review of the existing medical literature on the relationship between these drugs and severe joint pain.

Based on this literature review, as well as the FDA's actions and their Adverse Event Reporting System, Health Canada is following suit and "working with manufacturers to update the product safety information for all DPP-4 inhibitors to communicate the risk of developing severe and disabling joint pain with the use of these drugs."

It will be interesting to see if Health Canada decides to use a strengthened version of the FDA's warning against disabling joint pain in their own warnings.

We will continue to monitor medical news and publications for new and increased warnings of the link between severe joint pain and the DPP-4 inhibitor class of drugs.

 

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