What Are Saxagliptin Side Effects?

Type-2 diabetes medication saxagliptin, sold under the brand name Onglyza, has been linked to a number of serious side effects, including congestive heart failure. As a result, many who have experienced this serious, and sometimes fatal cardiac complication have filed Onglyza lawsuits.

This danger was the subject of a Drug Safety Communication issued by the U.S. Food and Drug Administration (FDA) in 2016. The warning included a similar medication, Nesina (algogliptin).

What is Saxagliptin?

Saxagliptin and alogliptin are part of a class of prescription medications known as dipeptidyl peptidase 4 (DDP-4) inhibitors or “gliptin” drugs. Used for the treatment of type-2 diabetes, this drug class also includes sitagliptin (Januvia) and linagliptin (Tradjenta), both of which are approved for sale in the U.S. Januvia was the first DDP-4 inhibitor to win FDA approval, which was granted in 2006.

The development of these medications originated with the discovery of DDP-4 in 1966. Once the function of DDP-4 in the body was understood, 25 years of research followed into how this naturally-occurring protein regulates various bodily functions, including immune function, cellular communication and life cycle, and the metabolism of blood sugar (glucose). It was research into the latter that led to the initial development of DDP-4 inhibitors in the mid-1990s.

Onglyza and other saxagliptin drugs have become increasingly popular in recent years, especially after the restriction of another major diabetes drug, Avandia, which has been linked with an increased risk of cardiac death.

How Does Saxagliptin Work?

DDP-4 inhibitors, such as saxagliptin, slow production of DDP-4, an enzyme that breaks down a group of hormones known as incretins. Maximizing the production of incretins increases the amount of insulin in the body following meals while decreasing the production of glucose in the liver.

Saxagliptin and similar drugs may be used alone or in conjunction with other medications, such as metformin or sulfonylurea drugs.

What is the Link Between Saxagliptin and Heart Failure?

Concerns about the side effects of saxagliptin and alogliptin on heart health arose due to the results of two randomized clinical trials. During these studies, researchers noted significant increases in hospitalizations for heart failure among patients taking the drugs in question as opposed to those who were given a placebo. Among patients who took saxagliptin, that risk was 27% higher than those in the control group.

The saxagliptin study was originally published in the New England Journal of Medicine in 2013.

Heart failure symptoms people taking saxagliptin should be on the lookout for include:

• Unusual shortness of breath
• Trouble breathing while prone
• Tiredness, weakness, or fatigue
• Weight gain and swelling in the ankles, feet, legs, or stomach

In response to recent research, the FDA conducted its own safety review and released a safety communication about the risk. “A safety review has found that type 2 diabetes medications containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease,” warned the federal agency.

Are There Other Saxagliptin Side Effects?

Patients who take saxagliptin in combination with a sulphonylurea such as Amaryl run the risk of dangerously low blood sugar levels. Other side effects that have been observed are:

• Upper respiratory tract infection
• Urinary tract infection
• Headaches
• Pancreatitis
• Pancreatic cancer

Who Makes Saxagliptin?

Sold as Onglyza, saxagliptin is manufactured and marketed by Bristol- Myers Squibb. Originally developed in partnership with AstraZeneca, Onglyza was granted FDA approval at the end of July 2009.

Do Other Gliptin Drugs Cause Similar Side Effects?

Aside from Onglyza and Nesina, the only other medication in the DDP-4 class of medications known to pose a risk of heart failure is Kombiglyze XR, which is a combination of saxagliptin and metformin.

What Are Symptoms of Heart Failure?

Patients who are at risk for heart failure from Onglyza may experience:

• chest pain
• persistent cough or wheezing
• swelling of the extremities due to fluid build-up (edema)
• generalized weakness
• respiratory distress
• dizziness
• tachycardia (rapid heartbeat)

Have There Been Saxagliptin Lawsuits Filed?

As of June 2018, there were over 200 saxagliptin lawsuits pending before the U.S. District Court for the Eastern District of Kentucky, where cases filed by plaintiffs across the country have been consolidated in multi-district litigation (MDL-2809).

Incredibly, although the dangers of saxagliptin were established in 2013 with the publication of the SAVOR-TIMI 53 study in the New England Journal of Medicine,  the FDA did not require Bristol-Meyer Squibb and AstraZeneca to add the information to its “Warnings and Precautions” labels until three years later.

While most U.S. saxagliptin claims are being heard in Kentucky, cases filed by California residents have remained in that state’s Superior Court for San Francisco County, where they are being heard by Judge Curtis Karnow (Case Number CJC16004909).

Are There Alternatives to Saxagliptin?

There are many different medications designed to treat type-2 diabetes over the years, although virtually all have been associated with side effects ranging from mild to life-threatening. The first-line treatment, metformin, is the least dangerous. Made from an extract of the French lilac (a folk remedy for centuries), metformin can cause flatulence, constipation, and Vitamin B deficiency. It can be taken alone but is often prescribed in combination with other type-2 diabetes medications.

Other alternatives include glitazone drugs (such as Actos) and SGLT2 inhibitors (Invokana, Farxiga, et. al.). However, both classes of drugs have serious side effects; SGLT2 inhibitors, in particular, are known to cause kidney disease, urogenital infections, and impeded blood flow to the extremities, increasing the risk of amputation.

Filing a Saxagliptin Lawsuit

More and more patients taking saxagliptin are turning to litigation over allegations of serious side effects, claiming they were not warned about these risks. If you or someone you love has suffered from these or other complications after taking saxagliptin, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by these issues, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, especially in the wake of major health issues, so Top Class Actions has laid the groundwork by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.