New York Dangerous Drug Liability Lawyers
Onglyza and Kombiglyze are drugs used to treat type 2 diabetes manufactured by AstraZeneca. Onglyza received approval from the Food and Drug Administration (FDA) in July 2009, but has recently come under scrutiny for an increase in the incidence of heart failure in users.
These drugs belongs to a group of Type 2 diabetes medications called DPP-4 inhibitors which are incretin-based therapies. This class of drug helps the pancreas secrete more insulin and stops the liver from producing excess sugar.
We are aggressively investigating claims of heart failure associated with the use of Onglyza an Kombiglyze.
FDA Adds Heart Failure Warning to Onglyza and Kombiglyze
Unlike many other drug litigations, Onglyza & Kombiglyze causing heart failure is based upon random controlled clinical trial data. The increased risk of heart failure is significant and viewed by the FDA as strong evidence of a causal relationship. The risk of heart failure nearly doubles over certain timeframes.
Recent scientific literature suggests an unacceptable increase in heart failure rate from the use of these drugs. A study, SAVOR, published in the New England Journal of Medicine cites one side effect Onglyza as an increased rate of heart failure. As a direct result of the study the FDA released a safety announcement in February 2014 informing the public that it requested clinical trial data to investigate a possible association between use of Onglyza and heart failure. Subsequently, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 14 to 1 that the FDA supplement the Onglyza's labeling to add new safety information over concerns of heart failure. One agency member even voted to completely withdraw the drug from the market.