Diabetes Medication Allegedly Linked to Heart Disease

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

A federal lawsuit has been filed by a New Jersey man against Bristol-Myers Squibb and Astrazeneca Pharmaceuticals drug manufacturers, alleging that he suffered injuries after taking the diabetes medication saxagliptin (brand names Onglyza and Kombiglyze XR). The lawsuit was filed on May 2, 2017 in the U.S. District Court, District of New Jersey. The plaintiff maintains he developed coronary heart disease and congestive heart failure after taking saxagliptin.

The plaintiff claims that the drug manufacturers allegedly were aware that there was an increased risk of adverse events associated with saxagliptin. According to his complaint, the drug manufacturers knowingly, purposely and deliberately failed to adequately warn patients, consumers, medical providers and the public of the increased risk of serious injury associated with saxagliptin. The lawsuit claims that Bristol-Myers Squibb failed to conduct adequate testing to confirm the safety of saxagliptin or to provide adequate training to sales representatives who sold the medication.

Additional Saxagliptin Lawsuit

A Texas resident filed a lawsuit against Bristol-Myers Squibb in February 2017. The plaintiff alleged that he suffered heart failure, heart failure, and hypoxic respiratory failure (a condition where there isn’t sufficient oxygen in the blood) after he took both Onglyza and XR (saxagliptin and metformin extended release). According to the lawsuit, the plaintiff took the drugs between 2010 and 2015.

National law firm Parker Waichman LLP has extensive experience and success in representing clients in pharmaceutical litigation, including Onglyza and other diabetes medications. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit

Heart Failure Indications

Heart failure means the heart is not strong enough to pump blood sufficiently to the rest of the body. The U.S. Food and Drug Administration (FDA) notes patients taking saxagliptin should seek medical attention immediately if they experience heart failure symptoms such as: unusual shortness of breath during daily activities; trouble breathing when lying down; tiredness, weakness, or fatigue; weight gain with swelling in the ankles, feet, legs, or stomach.

Saxagliptin Background

Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor and is used in the treatment of type 2 diabetes. Diabetes is a condition in which blood sugar is too high because the body does not produce or use insulin normally.  Saxagliptin is meant to be taken along with a diet and exercise program. It works by increasing the amount of insulin released by the body and by decreasing the amount of sugar made by the body.

The FDA approved Onglyza (saxagliptin) in 2009. In April 2016, the FDA issued a drug safety communication adding heart failure risk warnings to labels of type 2 diabetes medicines that contain saxagliptin and alogliptin.

“Type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease,” wrote the FDA in its warning. “Heart failure can result in the heart not being able to pump enough blood to meet the body’s needs.” That same year, Astrazeneca added heart failure risk warnings to Onglyza and Kombiglyze XR.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met in April 2015, to discuss the heart risks of diabetes drugs. The expert panel examined data from the SAVOR trial, which contained data from approximately 16,000 patients. A major cardiovascular event was reported in 1,222 of the patients. Panelists found that the Onglyza warning label should be updated to include the risk of heart failure, noting a 27 percent increased risk of heart failure hospitalizations in patients taking saxagliptin compared to a placebo.

Other Saxaglipin Potential Side Effects

Severe and on occasion, fatal inflammation of the pancreas (pancreatitis) has been reported in patients taking saxagliptin. The pancreas produces enzymes that help digestion and hormones that help regulate the way the body processes sugar (glucose). Pancreatic damage happens when the digestive enzymes are activated before they are released into the small intestine and begin attacking the pancreas.

Symptoms include severe or persistent stomach ache, or back pain with or without nausea or vomiting, fever, rapid pulse, and losing weight without trying, according to the Mayo Clinic.

Acute pancreatitis is a sudden inflammation that lasts for a short period of time. It may range from mild discomfort to a severe, life-threatening illness. In severe cases, acute pancreatitis can result in bleeding into the gland, serious tissue damage, cyst formation, and infection. Severe pancreatitis may also harm other vital organs such as the kidneys, lungs, and heart, reports WebMD.

Legal Help for Diabetes Medication Users

If you or someone you know has been affected by Onglyza or similar diabetes medications, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).