According to a preliminary report released Friday by the U.S. Food and Drug Administration (FDA), AstraZeneca’s diabetes drug, Onglyza, may be associated with an increased risk of premature death.
A study involving more than 16,000 patients taking Onglyza for type 2 diabetes found that the drug increased heart failure by 27 percent, as well as increasing mortality of all causes. According to Modern Health Care, the analysis is scheduled to be presented on April 14 to an FDA advisory committee.
The results of the study increases concerns about a class of diabetes medications called DPP-4 inhibitors, which include AstroZeneca’s Onglyza and Takeda Pharmaceuticals Nesina.
Safety concerns for DPP-4 inhibitors to treat type 2 diabetes have been raised for years, and manufacturers of diabetes drugs have been required since 2008 to provide evidence that their medications do not increase cardiovascular risks.
A 2013 study published in the New England Journal of Medicine said that Onglyza neither increased nor decreased the rate of heart attack, stroke, or death. But in February, 2014, the FDA announced that it considered the data from that study preliminary, and would analyze the trial data.
According to Yahoo Finance, a more detailed analysis of the data revealed that that the drug did, in fact, pose not only a heart failure risk, but a possible increased all-cause death risk.
The FDA conceded that some patients may have had serious pre-existing medical conditions that contributed to the findings, but still expressed concern over the higher incidence of hospitalizations for heart failure and death in Onglyza users over those who were given a placebo or other DPP-4 inhibitors.
The diabetes drug was approved by the FDA in 2009, and reportedly generated more than $800 million in sales for AstraZeneca in 2014 alone.
Bloomburg reports that FDA staff did not find an increase in deaths related to Nesina, and a related drug, Merck & Company’s Januvia, is still being studied. If the results show no increased cardiovascular risks for Januvia, AstraZeneca could face a huge cut in sales for Onglyza.
The advisory committee is expected to give recommendations on what action should be taken by the FDA regarding Onglyza, but it is not expected to be pulled from the market. Likely actions would be to restrict distribution of the drug or require a labeling change reflecting the risks and adding new safety information.
Yet investors are still cautious, and AstraZeneca stock was down.3 percent on Friday after the announcement was made.
If you prefer not to take the risks of diabetes drugs, this Inquisitr report cites a well-known doctor who proposes a different approach to treating type 2 diabetes.
[Image via Diatribe]