What is the FDA’s Current Stance on Onglyza (Saxagliptin)?
Many have questions regarding Onglyza (Saxagliptin) and the Food & Drug Administration or what the FDA stance on Onglyza (Saxagliptin) really is. Onglyza is a prescription drug, used to treat Type 2 Diabetes when drugs such as metformin and sulphonylureas have failed to adequately control the disease. Onglyza was approved by the FDA in 2008, as a DPP-4 inhibitor—the same class of drug as Merck’s Januvia.
Despite the fact that Onglyza was one of the first drugs to successfully pass the slightly stricter rules for diabetes drugs as far as cardiovascular disease and cardiovascular events, within a couple of years of when Onglyza became available to the public, adverse event reports from physicians and patients began coming in to the FDA. While there are Onglyza (Saxagliptin) FDA Warnings regarding the drug, some believe these warnings should be stronger, or even that there should be an Onglyza (Saxagliptin) recall.
Is the Onglyza (Saxagliptin) FDA Warning Adequate?
Although there have been some Onglyza (Saxagliptin) FDA Warnings and Onglyza (Saxagliptin) FDA notices, there has not yet been an Onglyza (Saxagliptin) recall. In 2016, it was determined that an Onglyza (Saxagliptin) FDA warning was necessary regarding an increased risk of heart failure. This risk was greater among those patients who have existing kidney or heart disease. Heart failure can result in an inadequate amount of blood being pumped to meet the body’s needs.
The FDA evaluated two large clinical trials conducted in patients with heart disease; 3.5 percent of patients who received Onglyza were hospitalized for heart failure, compared to 2.8 percent of the patients in the trial who received the placebo. The Onglyza (Saxagliptin) FDA warning cautioned patients who had any of the following symptoms of heart failure to contact their health care professional right away:
- Unusual shortness of breath;
- Weight gain along with swelling in the stomach, legs, feet or ankles;
- Unusual weakness or fatigue, or
- Trouble breathing when lying down.
Have There Been Adverse Event Reports or FDA Safety Communications Regarding Onglyza (Saxagliptin)?
In 2015, the FDA received adverse event reports regarding Onglyza and similar DPP-4 drugs. Some of the adverse event reports regarded renal failure, and the FDA stated they were evaluating the need for further regulatory action. Other adverse event reports claimed mouth ulcerations and stomatitis as a result of taking Onglyza and other similar DPP-4 drugs. The Postmarketing Experience section of the labeling for products containing linagliptin was updated to reflect mouth ulcerations and stomatitis as possible side effects, while for Onglyza and other Saxagliptin drugs, the FDA stated they were evaluating the need for further regulatory action.
What About Onglyza (Saxagliptin) Clinical Studies?
The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded) was a randomized, double-blind, placebo-controlled Phase 4 study which was intended to determine the cardiovascular risk associated with Saxagliptin. Among the 16,492 patients with Type 2 diabetes, the SAVOR study found that more patients treated with Saxagliptin were hospitalized for heart failure compared to those taking a placebo drug (3.5 percent vs. 2.8 percent). The final analysis of the study was that Saxagliptin treatment was associated with an increased risk of hospitalization for heart failure, although the risk was highest among patients with elevated levels of natriuretic peptides, chronic kidney disease or prior heart failure.
Will There Be a Onglyza (Saxagliptin) Potential Recall?
Both Onglyza and the combination drug Kombiglyze are used to treat Type 2 diabetes; Saxagliptin is an active ingredient in both drugs which were developed jointly by Bristol-Myers Squibb and AstraZeneca. Despite the fact that more and more serious side effects to these drugs are being reported (pancreatitis, pancreatic cancer, thyroid cancer, heart failure) at this time, there is no Onglyza (Saxagliptin) potential recall. This is not to say that there will not be an Onglyza recall in the future, particularly as the number of Onglyza lawsuits increases and more people who have been harmed by the drug come forward.
Did AstraZeneca and Bristol-Myers Squibb Exhibit an Onglyza (Saxagliptin) Failure to Warn?
As of March 29, 2018, 84 federal lawsuits had been filed against AstraZeneca and Bristol-Myers Squibb, claiming an Onglyza (Saxagliptin) failure to warn. One Kentucky woman indicated she suffered heart failure, congestive heart failure and cardiovascular injury after taking Onglya. According to this particular lawsuit, Cathy Nelson took Onglyza and Kombiglyze XR from April 2014 to August 2016, when she was diagnosed with a number of heart problems. Nelson’s lawsuit—and others—claim neither she nor her doctor were adequately informed regarding the risk of heart failure linked to Onglyza and that the manufacturers of Onglyza deliberately deceived patients and the medical community.
Other DPP-4 Inhibitors Which Work Like Onglyza (Saxagliptin)
There are other drugs similar to Onglyza (Saxagliptin) which are also DPP-4 inhibitors (Gliptins). Januvia (Sitagliptin) was the first DPP-4 inhibitor drug which worked by increasing levels of GLP-1 in the bloodstream, and Galvus (Vildagliptin) and Nesina (Alogliptin) came soon after. Onglyza (Saxagliptin), Kombiglyze (Saxagliptin mixed with metformin), and Tradjenta (Linagliptin) are the newest drugs in this family. The gliptin drugs are typically used for patients who have not responded to sulphonylureas or metformin.
Those who have suffered injury after taking Onglyza should speak to an experienced Onglyza (Saxagliptin) injury attorney from Sullo & Sullo who can evaluate the facts of the case and determine whether an Onglyza (Saxagliptin) lawsuit is appropriate.