Alleged Side Effects of Onglyza

Onglyza (saxagliptin) is a popular diabetes medication developed jointly by AstraZeneca and Bristol-Myers Squibb, and is prescribed to help control blood sugar levels in adults with Type 2 diabetes. Approved by the FDA in July 2009, Onglyza belongs to a class of diabetes drugs called incretin mimetics, which work by mimicking the functions of the natural incretin hormones in the body that help lower post-meal blood sugar levels. Onglyza falls into the category of incretin mimetic diabetes drugs called dipeptidyl peptidase 4 (DPP-4) inhibitors, which means the prescription medication blocks DPP-4, a protein that increases blood glucose levels.

AstraZeneca Questions Onglyza Heart Failure Risk

At a meeting of the American Diabetes Association (ADA) in June, Onglyza maker AstraZeneca presented data suggesting that there is no evidence linking the use of Onglyza to an increased risk of hospitalization from heart failure. This Onglyza report submitted by AstraZeneca is a review of data from an observational, retrospective insurance claims database study, and the findings contradict a growing number of studies published in recent years, which have indicated that Onglyza users may face an increased risk of severe side effects from the diabetes drug, including heart failure, pancreatitis, pancreatic cancer and thyroid cancer.

FDA Requires Stronger Onglyza Warnings

In light of this alleged Onglyza side effect risk, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 in April, to require stronger warnings on the Onglyza label, regarding the higher-than-expected risk of hospitalization and all-cause mortality among patients using the Type 2 diabetes drug. In spite of these FDA recommendations, AstraZeneca is now claiming that its new analysis of the SAVOR clinical trial, which involved 16,492 patients with Type 2 diabetes prescribed Onglyza or a placebo, suggests that Onglyza and another diabetes drug called Januvia were associated with lower risks of hospitalization for heart failure than another class of diabetes drugs known as sulfonylureas.

A Qualified Onglyza Lawyer Can Help

AstraZeneca’s new report is in direct conflict with a previous SAVOR review by the FDA, which indicated that the clinical trial results showed a potential 27% increased risk of hospitalization from heart failure among Onglyza users. The FDA review of the SAVOR clinical trial results also found an increased risk of cardiovascular death and death from all causes associated with Onglyza. If you believe you have been adversely affected by side effects of Onglyza, such as heart failure or pancreatic cancer, contact a reputable Onglyza attorney today to discuss your possible compensation options.

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.

Pancreatitis, Pancreatic Cancer Linked to DPP-4 Inhibitors

Since DPP-4 inhibitor drugs like Merck’s Januvia (sitagliptin) and AstraZeneca and Bristol-Myers Squibb’s Onglyza (saxagliptin) first entered the market, the prescription medications have become some of the most widely-used drugs for the treatment of Type 2 diabetes, largely because they have been associated with fewer side effects than other available diabetes treatments. However, a growing number of studies have suggested that patients who take DPP-4 inhibitors like Onglyza or Januvia may face an increased risk of serious medical complications, including pancreatitis and pancreatic cancer.

And, while some recent studies have contradicted these findings, the U.S. Food and Drug Administration (FDA) announced in 2013 that it is “evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics,” like Onglyza and Januvia.

Possible Risks of Long-Term DPP-4 Inhibitor Use

In a study conducted in September 2014, researchers from the UNC Gillings School of Global Public Health and the UNC School of Medicine found that “short-term use of DPP-4 inhibitors in older diabetes patients does not increase their risk of pancreatic cancer,” according to John Buse, MD, PhD, director of the Diabetes Care Center at UNC and co-author of the study. “However we cannot address the long-term safety, yet. There are just not enough people who have taken the drugs for many years.” The concern here, is that patients who take Onglyza and other DPP-4 inhibitors for long periods of time may face a higher risk of pancreatitis and pancreatic cancer than patients who take the Type 2 diabetes medications for a shorter period of time.

In February 2012, Bristol-Myers Squibb and AstraZeneca added new safety information on the use of Onglyza in South Africa, indicating a possible link between Onglyza use and side effects like pancreatitis and sensitivity to saxagliptin and other DPP-4 inhibitors. The following year, a Januvia study reported “worrisome changes in the pancreases of rats that could lead to pancreatic cancer,” which led the FDA and the European Medicines Agency to undertake independent reviews of the potential connection between DPP-4 inhibitors and pancreatic cancer. The FDA concluded that “Although the totality of the data that have been reviewed provides reassurance, pancreatitis will continue to be considered a risk associated with these drugs until more data are available.” Another study published in the medical journal Diabetes in March 2013, found that Onglyza and similar medications were tied to an increased risk of abnormal precancerous cells in the autopsied pancreases of people taking the diabetes drugs.

Contact a Reputable Drug Injury Lawyer for Help

DPP-4 inhibitor diabetes drugs like Onglyza and Januvia are designed to increase the size and number of beta cells in the pancreas, because these cells are responsible for secreting insulin. However, research has shown that, while the medications can, in fact, increase the number of beta cells, the cells may be abnormal and may be accompanied by small tumors called adenomas, which can become malignant. If you believe you have been adversely affected by side effects of Onglyza or another DPP-4 inhibitor diabetes medication, contact a reputable drug injury lawyer today to discuss your options for legal recourse. With a qualified attorney on your side, you can protect your legal rights and pursue the financial compensation you deserve for your injuries, medical expenses, and pain and suffering.