Sarah Markley  |  September 22, 2017

Category: Legal News

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Onglyza heart failure diabetesA Georgia woman has filed a lawsuit against the manufacturers of her diabetes medication claiming that Onglyza and heart disease are linked.

Georgia-based plaintiff Cynthia T. has filed this Onglyza and heart disease lawsuit against drug manufacturers Bristol-Myers Squibb and Astrazeneca as well as McKesson Corporation, a distributor of the drug.

Cynthia says she took Onglyza, generically known as saxagliptin, as well as Kombiglyze XR. Kombiglyze XR is saxagliptin combined with metformin.

Onglyza and Heart Disease

Saxagliptin was approved for use by type-2 diabetes patients in 2009 by the U.S. Food and Drug Administration.

Saxagliptin is a DPP-4 inhibitor. This means that the naturally occurring enzyme, DPP-4, is prevented from breaking down the body’s incretin hormone called GLP-1. GLP-1 is released in the body after someone eats and indicates that the body should make insulin.

Saxagliptin inhibits DPP-4 which allows the GLP-1 to stay in the body for longer. This, in turn, allows the body to make more insulin, which encourages the body to process the sugar in the blood.

Later, after both Onglyza and Kombiglyze XR were on the market (Kombiglyze XR was approved in 2010), a clinical trial called the SAVOR study found that Onglyza and heart disease were linked.

According to the SAVOR study, those patients taking Onglyza were hospitalized for heart disease significantly more than the placebo group. In fact, they found a 27% increased risk of heart disease for those who took saxagliptin.

An advisory committee looked at the findings and almost unanimously voted to include a heart disease warning on the labels of drugs containing saxagliptin.

It wasn’t until July 2016 that the FDA required saxagliptin labels to include a new warning that said the risk of heart failure could be increased with saxagliptin use. This is a risk particularly for those who already have heart disease or kidney disease.

The FDA stated that two major studies found that saxagliptin patients were hospitalized for heart failure at a much greater rate than those who did not take the drug.

The plaintiff in this Onglyza and heart disease lawsuit claims that she took saxagliptin from 2013 until 2014. She alleges that she used the drug as she was instructed to by her doctor and as it was intended by the manufacturer.

Cynthia claims, according to her Onglyza and heart disease lawsuit, that she began developing very serious and life-threatening side effects from her use of saxagliptin. She alleges that her saxagliptin conditions included heart failure, congestive heart failure and cardiovascular injury.

Cynthia claims that the drug companies did not adequately warn her of the risks of taking such a drug. She alleges that if she had known of the serious risks of Onglyza and heart failure, she would not have taken saxagliptin at all.

This Onglyza Lawsuit is Case No. 1:17-cv-02782-CAP, in the U.S. District Court for the Northern District of Georgia.

In general, Onglyza lawsuits and Kombiglyze XR lawsuits are filed individually by each plaintiff and are not class actions.

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