Onglyza belongs to a class of diabetes medications called DPP-4 inhibitors, FDA clinical trial data shows there may be a risk of death for some patients.
San Diego, CA, July 31, 2015 (Newswire.com) - AstraZeneca’s blockbuster diabetes drug Onglyza may be linked to an increased risk of death for some patients, according to a preliminary review of clinical trial data by the U.S. Food and Drug Administration (FDA). The FDA report was published on the agency’s website ahead of a scheduled FDA advisory panel meeting in April 2015, to discuss the potential for Onglyza and a similar diabetes drug to cause life-threatening cardiovascular side effects in users. If you took Onglyza in the past, and you have since suffered heart failure or another major complication, consult an experienced Onglyza injury lawyer today to explore your possible compensation options.
Possible Side Effects of Onglyza.
Onglyza (saxagliptin) belongs to a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors, which are designed to be used in combination with diet and exercise to control high blood sugar in patients with Type 2 diabetes. However, a number of studies published in recent years have indicated that some of the best-selling diabetes drugs in the United States may pose a risk of serious side effects for users, and DPP-4 inhibitors like Onglyza have been tied to a possible increased risk of pancreatitis, pancreatic cancer and other complications. Based on this recent FDA report, Onglyza users may also face an increased risk of heart problems possibly leading to death.
FDA Warnings for Onglyza Users
Beginning in 2008, the FDA has asked the makers of Type 2 diabetes medications to provide evidence that their prescription drugs don’t increase the risk of heart attack or other heart-related side effects, advising the companies to “conduct a more thorough examination of their drugs’ cardiovascular risks during the product’s development stage.” In the FDA’s recent Onglyza report, the agency examined the findings of a clinical trial of more than 16,000 patients known as SAVOR, conducted in 2013, which showed that Type 2 diabetes patients taking Onglyza had a 27% increased risk of hospitalization due to heart failure, compared to patients who were given a placebo.
The potential for Onglyza to increase the risk of heart failure in diabetes patients was first discussed in a report published in the New England Journal of Medicine in October 2013, shortly after the SAVOR clinical trial was conducted, and the following year, the FDA announced that it would analyze the clinical trial results as part of its broader examination of the risk of cardiovascular side effects from Type 2 diabetes medications. Now the FDA has finally weighed in on the SAVOR trial results, and the agency indicates that the heart failure risk from Onglyza is valid, and also notes a “significant or near-significant” increased risk of Onglyza-related death from all causes.
Contact a Skilled Onglyza Lawyer Today
Approved by the FDA in 2009, Onglyza has become a popular treatment method for patients with Type 2 diabetes, and the medication generated $820 million in sales for AstraZeneca in 2014 alone. However, Type 2 diabetes patients who take Onglyza and similar DPP-4 inhibitor medications may face an increased risk of potentially life-threatening side effects, including pancreatitis, pancreatic cancer and heart failure. If you believe you have been adversely affected by alleged Onglyza side effects, contact a reputable Onglyza attorney today for legal help. You may be entitled to financial compensation for your injuries, which you can pursue by filing a drug injury claim against AstraZeneca.
This article was originally published at: http://onglyzalawsuit.info/fda-warns-onglyza-diabetes-drug-may-increase-risk-of-patient-death/