Onglyza Lawsuit | Diabetes Drug Linked to Heart Conditions

Onglyza (saxagliptin) is an oral type 2 diabetes medication that works to control blood sugar levels by regulating the insulin levels the body produces after eating.

It is in the class known as gliptins (DPP-4 inhibitors).

Onglyza is manufactured by Bristol-Myers Squibb (BMS) and AstraZeneca Pharmaceuticals LP and was approved by the FDA in July 2009.

Onglyza is not used to treat type 1 diabetes and is not approved for use by anyone less than 18 years of age.

The drug is sometimes used in combination with other diabetes medications as part of a program of treatment that includes proper diet, exercise, and weight control.

DPP-4 inhibitors are in a relatively new class of oral diabetes drugs that are typically prescribed to patients with type 2 diabetes who have not responded well to other drugs, such as metformin and sulphonylureas.

Besides Onglyza, other drugs in this class include Januvia (sitagliptin), Galvus (vildagliptin), and Tradjenta (linagliptin).

Onglyza helps to control high blood sugar levels by increasing the amount of incretin in the body, prompting the pancreas to release insulin and decrease the body’s release of glucagon.

DPP-4 inhibitors like Onglyza inhibit natural enzymes from stopping the action of incretin, which allows for the stimulation of insulin to continue for a longer period of time than what usually occurs after someone has a meal.

On April 5, 2016, the FDA issued a drug safety communication for Onglyza and its sister medication Kombiglyze XR, as well as Nesina, Kazano, and Oseni, ordering that the medications’ labels include a warning for an increased risk of heart failure.

All of these medications fall under the DPP-4 class of drugs.

The agency also directed patients to contact their healthcare providers immediately should they experience shortness of breath during normal daily activities, trouble breathing while lying down, tiredness, weakness, fatigue, or weight gain with swelling in the ankles, feet, legs or stomach.

Cardiovascular disease causes most of the deaths among those with diabetes and for this reason, the question of cardiovascular safety for new drugs developed to treat type 2 diabetes, including Onglyza, is considered to be extremely important for public health.

For this reason, in December 2008, the U.S. Food and Drug Administration (FDA) issued guidance requiring drug companies to conduct studies to demonstrate that the new diabetes drugs do not increase cardiovascular risk.

Amid growing concern regarding the safety of the new diabetes drugs, in 2014 the FDA released a preliminary report discussing the results of the SAVOR-TIMI 53 clinical trial involving more than 16,492 type 2 diabetes patients.

The purpose of the study was to determine whether or not saxagliptin gave patients any heart protective benefits in addition to controlling blood sugar levels, but the report showed, which was published in the New England Journal of Medicine, that the patients taking Onglyza had a 27 % increased risk of hospitalization due to heart failure, and also a possible increased risk of death from all causes.

In this clinical trial, 3.5% of patients who received saxagliptin, were hospitalized for heart failure versus 2.8% of patients who received a placebo.

According to the FDA, the causes of death were “multifactorial,” meaning that the patients may have suffered from several serious medical conditions prior to their death.

In February 2013, researchers at Johns Hopkins found that people with type 2 diabetes hospitalized for pancreatitis were two times as likely to be on an incretin mimetic drug.

Pancreatitis can lead to pancreatic cancer.

Then in March 2013, a study published in the specialty journal Diabetes found that patients taking Onglyza had a pancreas 40% larger than normal.

The enlarged pancreas also contained more pre-cancerous growths and small tumors.

A “Dear Doctor” letter from Bristol-Myers Squibb and AstraZeneca on the UK Medicine and Healthcare Products Regulatory Agency’s website say:

“A review of reports of pancreatitis from post-marketing experience revealed signs of pancreatitis occurred after the start of saxagliptin treatment and then resolved after discontinuation, which is suggestive of a causal relationship.”

Pancreatitis has been recognized as an adverse event for DPP-4 inhibitors.

Side effects commonly associated with Onglyza use include:

• headaches
• gastroenteritis
• severe nausea and vomiting
• respiratory tract infections
• urinary tract infections
• severe pain in your upper stomach (that spreads to your back)
• swelling of hands, ankles, feet
• swelling of the face, lips, tongue, throat
• signs of an allergic reaction which can include hives, red rash that causes blistering

Patients and medical professionals should be aware that Onglyza use could prompt episodes of low blood sugar levels (hypoglycemia).

Hypoglycemia can be experienced by anyone who suffers from diabetes, and symptoms include:

• headache
• hunger
• sweating
• paleness
• irritability
• dizziness
• shakiness
• trouble concentrating

Type 2 diabetes is a chronic disease that affects approximately 27 million people in the U.S.

Although people with type 2 diabetes make insulin, their cells don’t use it as well as they should in order to handle the sugar in their blood –  this is known as insulin resistance.

While not everyone with type 2 diabetes is overweight, research has found that obesity, or a lack of physical activity, can cause insulin resistance, especially among those who carry extra weight in their midsection.

Type 2 diabetes can affect children and teenagers as well as adults, chiefly because of childhood obesity.

The Onglyza lawsuit makes similar allegations against drug makers Bristol-Myers-Squibb and AstraZeneca, charging that the companies:

• Failed to warn consumers that Onglyza use can cause heart failure, cardiac failure, congestive heart failure, and death from heart failure.
• Ignored December 2008 FDA guidance that urged drug makers to demonstrate that the new therapies wouldn’t result in an unacceptable risk of cardiovascular events.
• Marketed and sold the medications for nearly five years before completing an adequate study of the cardiac risks associated with saxagliptin.
• Conveyed untrue and distorted information concerning the safety and effectiveness of saxagliptin and concealed the risks of serious adverse events.
• Actively concealed these risks from consumers and healthcare professionals.
• Promoted and continue to promote Onglyza as a safe and effective treatment for type 2 diabetes patients.
• Purposely delayed their efforts to change the labels and reference materials for saxagliptin to include a warning regarding increased risk of heart failure, congestive heart failure, cardiac failure, and death related to use of the medication.
• The pending Onglyza lawsuits, as well as any Onglyza lawsuit filed in federal courts in the future, are being consolidated in U.S. District Court in the Eastern District of Kentucky, where they will undergo coordinated pretrial proceedings, including discovery. At some point, several representative cases will be chosen for a series of bellwether trials that are intended to provide insight as to how juries might decide similar lawsuits and as a potential pathway to faster settlements.