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Amid continuing concerns about the potential risk of heart failure from Onglyza and Januvia, the findings of new reserach failed to find evidence that users of the diabetes drugs are more likely to experience heart problems.
In a study funded by the FDA and published last week in the Annals of Internal Medicine, researchers examined data involving nearly 80,000 Onglyza users and almost 300,000 Januvia users over an average of seven to nine months, comparing the risk of hospitalized heart failure (hHF) to users of Actos, sulfonylureas and insulin.
Researchers found no evidence of an increased risk of hospitalization due to heart failure among users of Onglyza and Januvia, and actually found that the risk may be slightly lower than with the other diabetes treatments. Both Onglyza and Januvia are part of a popular class of type 2 diabetes drugs, known as ad dipeptidyl peptidase-4 (DPP-4) inhibitors, which also includes Kombiglyze XR, Nesina, Kazano and Oseni.
Januvia (sitagliptin) is one of Merck & Co’s best-selling drugs and top drugs currently on the market in the United States. It brought the company $1.9 billion in sales in just the first half of 2015. Janumet is another version of the medication, which combines Januvia and Metformin, generating an additional $1 billion for the company.
In recent years, the drug maker has faced a number of Januvia lawsuits alleging that inadequate warnings were provided about the risk of users developing pancreatic cancer.
Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol-Myers Squibb, but is now owned wholly by AstraZeneca. It was approved by the FDA in July 2009, for treatment of type 2 diabetes and generated more than $700 million in sales in 2012.
Most of the concerns over the heart failure risk in recent years has focused on Onglyza, which led the FDA to require new warnings earlier last month and a growing number of individuals nationwide are now pursuing an Onglyza lawsuit against AstraZeneca, alleging that consumers and the medical community were not provided adequate warnings about the potential heart risks.
Concerns about the link between Onglyza and heart failure emerged following the publication of a study, known as “SAVOR”, by the New England Journal of Medicine in 2013.
In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart risks, after a review of data from clinical trials suggested that users may face a higher than expected risk of hospitalization for heart failure and all-cause mortality.
The review looked at two large clinical trials involving patients with heart disease. In both trials, patients given drugs containing saxagliptin or alogliptin were at a higher risk of being hospitalized for heart failure than those given a placebo.
On April 5, the FDA issued a drug safety communication following the results of a review started in 2014. The FDA announced that new heart failure warnings will required for the diabetes drugs Onglyza, Kombiglyze XR, Nesina, Kazano, and Oseni, which are part of a class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors.