The FDA recently announced its plans to investigate the type 2 diabetes drug Onglyza (saxagliptin) and its association with heart failure. The federal agency requested clinical trial data to analyze from the drug’s manufacturer, AstraZeneca. Our team of Onglyza lawyershopes that this investigation will lead to more restrictions on this dangerous drug.
Onglyza is an oral tablet used along with diet and exercise to control high blood sugar levels in patients with type 2 diabetes. It is often prescribed in combination with another drug, Kombiglyze XR, to increase the amount of insulin the body produces after meals.
This investigation is in reaction to a study recently published in the New England Journal of Medicine, which found a substantially increased rate of hospitalization for heart failure in Onglyza patients. Surprisingly, despite the increased risk of heart failure, the study did not note any increased rates of death, heart attack or stroke in the same patients.
Diabetes Drugs Subject to Heightened FDA Scrutiny
AstraZeneca has until March 2014 to submit its clinical trial data to the FDA. According to its website, this Onglyza investigation is part of a broader evaluation of all medications that treat type 2 diabetes. With the epidemic of diabetes in the United States, the list of medications to treat this ailment is long, complex and confusing to many patients. As more and more Americans are diagnosed with this disorder, the amount of prescriptions written and filled is also rising in extreme rates.
There are risks and side effects that come with any type of medication, whether it is for diabetes or osteoporosis. The main concern with type 2 diabetes medications is the heightened risk of cardiovascular side effects, and, in one particular class, the risk of pancreatic cancer (this refers to recent litigation over Byetta, Victoza, Januvia and Janumet.)
The clinical trial at issue over Onglyza is called SAVOR-TIMI 53 (SAVOR), and was published in September 2013. SAVOR enrolled nearly 16,500 patients and placed half on the medication and half on a placebo. Ultimately, about 3.5% of Onglyza-prescribed patients had to be hospitalized for heart failure – which happens when the heart does not pump blood well enough -compared to just over 2% of placebo patients.
Increased Risks without Any Clear Benefits
Since the FDA is merely taking a closer look into the SAVOR trial and not conducting a new, larger Onglyza study, it is quite unlikely that this investigation will provide any clear-cut or definitive answers. The drug was approved in 2009, and is among AstraZeneca’s best-selling medications, with sales expected to top $1 billion in 2015.
As stated, diabetes medications are booming in the U.S. despite lack of substantial evidence that they can do more for patients than diet and exercise alone. According to the Mayo Clinic, healthy lifestyle choices (weight control, daily physical activity, diet and portion control), provide the foundation for managing type 2 diabetes. Yes, in severe cases some patients may require medication to achieve optimum blood sugar levels, however, for most patients this is not the case.
Drug companies want you to depend on their medications, or more ideally, depend on a combination of their medications (Onglyza + Kombiglyze). Diabetes drugs are among AstraZeneca’s five priority growth areas, so it has a large incentive to keep these drugs on market and in the cabinets of diabetics. The actual benefits of medications like Onglyza and AstraZeneca’s other top-selling drug, Crestor, compared to their risks is ominous at best.
Crestor, for example, is now the subject of major litigation throughout the country. The drug is a statin intended to treat high cholesterol (which, coincidentally, can also be managed best through healthy lifestyle changes alone) and is associated with serious heart-related conditions. Among them include congestive heart failure, irregular heartbeat, strokes and heart attack, to name only a few.
Countless victims and families have suffered devastating, life-changing injuries from Crestor and Onglyza. What makes these cases even more devastating is that many patients never really needed to be on these medications in the first place. Manufacturers like AstraZeneca merely incentivize physicians and aggressively market to patients to make them believe they do.
Onglyza attorneys at Pintas & Mullins Law Firm are currently investigating cases of severe cardiac injury from Onglyza, Crestor, and countless other medications. We offer free, no-obligation legal consultations to potential clients nationwide, so you have nothing to lose and everything to gain by contacting us.