Morgan & Morgan is looking into claims related to the ability of the diabetes drug Onglyza to cause heart failure and death.
Onglyza (saxagliptin), manufactured by AstraZeneca, is FDA-approved for the treatment of Type 2 diabetes. It belongs to a new class of diabetic drugs known as DPP-4 inhibitors. Drugs like Onglyza are intended to lower glucose levels and diabetic complications in adults with Type 2 diabetes.
According to the Food and Drug Administration (FDA), Onglyza users may face an increased risk of congestive heart failure. A recent meeting of an FDA advisory committee recommended that Onglyza labeling be updated to warn against heart failure risk—a warning that was previously not included on the medication’s label.
If you or a loved one has taken Onglyza and suffered heart failure and/or death, you may have a case for compensation against AstraZeneca. To learn more about your legal rights, contact Morgan & Morgan for a free case review.
Why Should Onglyza Users Be Concerned?
Type 2 diabetes patients who take Onglyza may be at increased risk for a specific type of cardiovascular complication: heart failure. Onglyza users may also face a higher risk of death overall.
These risks are based on a 2013 study published in the New England Journal of Medicine (NEJM) which found that, compared to a placebo, saxagliptin resulted in a 27% increase in the rate of patient hospitalization for heart failure. The study also found that saxagliptin users had increased risk for all-cause mortality.
Based on the NEJM study findings, the FDA convened a meeting of its Endocrinologic and Metabolic Drugs Advisory Committee in April 2015 to assess the heart failure risk of Onglyza. 14 of 15 committee panelists voted for an updated Onglyza label that warns about the risk of increased heart failure. One panel member voted to withdraw Onglyza from the U.S. market.
Why Didn’t Original Onglyza Label Contain Heart Failure Warning?
The FDA in 2008 announced new recommendations on evaluating the risks of new Type 2 diabetes drugs. Specifically, the FDA stated that “companies should conduct a more thorough examination of their drugs’ cardiovascular risks during the product’s development stage.”
Onglyza met the statistical criteria for cardiovascular events (such as heart attacks) provided by the 2008 FDA Guidance, but the FDA had questions about the sufficiency of studies used to meet this criteria and was not convinced of the drug’s cardiovascular safety. AstraZeneca actually wanted to include a statement in Onglyza prescribing information that said saxagliptin may be associated with a reduced risk of cardiovascular events, but the FDA did not allow this based on clinical study data limitations.
These same limitations prompted the FDA to require more stringent post-approval Onglyza testing. In other words, the FDA, due to insufficient information obtained from premarketing studies, had questions about whether Onglyza met its guidelines for cardiovascular safety, so it ordered AstraZeneca to perform additional testing after the drug was approved. The study performed to meet this post-marketing requirement was the 2013 NEJM study, which found an increased risk of heart failure for Onglyza users.
There are major differences between pre and post-market testing of Onglyza which can explain why the original testing was inconclusive in terms of cardiovascular findings. For example, in clinical trials, patients were tested for a median of 62 weeks (1.19 years), while the post-marketing study followed patients for a median of 2.1 years.
Rather than performing more comprehensive testing of Onglyza prior to FDA-approval, AstraZeneca waited until after the drug was approved to perform this testing. The result is that thousands of patients may have been unnecessarily exposed to heart failure and death risks.
Discuss Your Case For Free With a Morgan & Morgan Onglyza Lawyer
Morgan & Morgan’s experienced personal injury legal team is speaking with Onglyza users who have suffered heart complications and assessing potential legal action against AstraZeneca.