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On July 24, 2017, a Georgia woman filed a new Onglyza lawsuit in the U.S. District Court for the Northern District of Georgia. She alleges that after she took Onglyza (saxagliptin) and/or Kombiglyze XR, which is a combination of saxagliptin and metformin, to help lower her blood sugar levels, she suffered from serious injuries. She has named manufacturers Bristol-Myers Squib and Astrazeneca, and distributor McKesson Corporation as defendants.

Plaintiff Blames Onglyza for Heart Failure

According to her complaint, the plaintiff used saxagliptin from 2013 to 2014. She says she used it as directed.

While using the drug, she claims that she developed serious adverse effects including heart failure, congestive heart failure, and cardiovascular injury. She blames defendants, stating that they did not adequately warn of the risks. If they had, her doctors would not have prescribed her the medications, or at least would have discussed the risks of heart failure with her.

The plaintiff seeks to recover damages for her pain and suffering, medical expenses, and lost wages and earning capacity. She also asserts that she is entitled to punitive damages.

Onglyza Found to Increase Risk of Heart Failure

The FDA approved Onglyza in 2009 for the treatment of type 2 diabetes, and Kombiglyze XR for the same purpose in 2010. Both drugs contain saxagliptin, which works by stimulating the pancreas to produce more insulin after a meal.

It belongs to a class of medications called “dipeptidyl peptidase-4 (DDP-4) inhibitors,” also called “incretin mimetics.” These drugs help patients produce more insulin to process blood sugar, so that blood sugar levels remain in a normal range.

After the drugs were on the market, FDA experts analyzed the findings of a clinical trial (the SAVOR study) on Onglyza and heart disease. They found that more patients in the Onglyza group were hospitalized for heart failure than the placebo group —a 27 percent increased risk, to be specific.

The FDA then convened an advisory committee to examine the evidence and make recommendations. The panel voted 14 to 1 for the FDA to require the manufacturers to add a heart failure warning to saxagliptin drugs.

The drug makers resisted making any label changes. In July 2016, however, the FDA required them to add a new warning on the product label indicating that saxagliptin could increase risk of heart failure, particularly in patients who already have heart or kidney disease. They noted that they had evaluated two large clinical trials conducted in patients with heart disease. In both trials more patients taking saxagliptin-containing medicines were hospitalized for heart failure than patients taking a placebo.

Plaintiff Claims Defendants Failed to Warn of the Risks

When the plaintiff was taking the drugs, however, they contained no warnings regarding the risk of heart failure so she was unaware of the link. She alleges in her complaint that the defendants should be held liable, as there were other medications she could have taken that would not have put her safety in jeopardy.

“In addition to Defendants refusing and failing to warn of the risks of heart failure, congestive heart failure, cardiac failure and death,” she states, “Defendants’ Saxagliptin drugs lack any benefit sufficient to tolerate the risks posed by its use because other anti-diabetes drugs are available that do not carry the increased cardiac risks of Saxagliptin.”



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