Type 2 diabetes drug Onglyza has proven so defective that the U.S. Food and Drug Administration has issued FDA warnings about Onglyza heart failure. Has a loved one suffered such an injury? If so, ask an experienced defective drug lawyer at Jim Adler & Associates about an Onglyza heart failure lawsuit in your behalf.
FDA Safety Review, Onglyza Recall
After receiving reports of heart failure or congestive heart failure by users of this defective drug, the FDA made a safety review of Onglyza, a brand name for a medicine which contains active ingredients saxagliptin and alogliptin. The FDA review found that Onglyza “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.”
Since heart failure can result in the heart being unable to pump sufficient blood for the body’s needs, Onglyza heart failure is a life-threatening condition.
One member of the FDA’s Advisory Committee even voted for outright withdrawal of the drug, though to date there has been no Onglyza recall. That doesn’t mean victims can’t file Onglyza lawsuits for heart failure injuries.
FDA Label Warnings for Onglyza, Kombiglyze
Despite no Onglyza recall yet, the FDA has added “Warnings and Precautions” to the labels of Onglyza and the only other diabetes medicine with saxagliptin, which is Kombiglyze XR (also known as Komboglyze). It also adds metformin HCl extended release, which Onglyza does not. Otherwise, they are much the same.
No generic drugs are available yet for Onglyza (released in 2009) or Kombiglyze (released in 2010), which remain patented.
The two drugs’ active ingredient of saxagliptin is among a class of prescription medicines known as dipeptidyl peptidase-4 (DPP-4) inhibitors. These are used with exercise and diet to lower and control blood sugar levels in adults with type 2 diabetes.
That disease affects almost 30 million Americans — making it a big money-maker for pharmaceutical companies offering drugs as treatments.
The two saxagliptin drugs’ contribution is to lower blood sugar, also called blood glucose, by helping the body increase the level of the hormone insulin after meals. But though such drugs may help in this regard, Onglyza side effects and Kombiglyze complications can be serious, necessitating heart failure lawsuits for victims.
The FDA label warnings on these drugs alert patients and healthcare professionals about “the potential increased risk of heart failure” and the risk of hospitalization as a result.
The FDA also advises that, prior to taking a saxagliptin drug such as Onglyza or Kombiglyze, patients should inform their healthcare professional if they have a history of heart failure or kidney impairment. That’s because a raised risk of hospitalization for heart failure was found in clinical trials which included patients with those medical issues.
FDA Studies Clinical Trials
The FDA studied two large clinical trials which were conducted with patients suffering heart disease. Both trials revealed that more patients who received saxagliptin-containing drugs were hospitalized for heart failure than patients who received an inactive placebo.
The FDA also cited a recent SAVOR clinical trial of cardiovascular risks linked to saxagliptin. (SAVOR stands for Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus.) It found a 27 percent increase in heart failure risks for those using the drug.
Imagine: Taking Onglyza could raise your risk of heart failure by 27 per cent.
The FDA also has urged patients and healthcare professionals to report Onglyza side effects to the FDA MedWatch program.
In addition, victims should alert a personal injury lawyer who can protect their legal rights after suffering injury due to negligence by a defective drug’s manufacturer. That may mean a defective drug lawsuit.
Onglyza Manufacturer Astrazeneca is to Blame
Starting in 2007, AstraZeneca and Bristol-Myers Squibb collaborated in researching, developing and commercializing Onglyza and Kombiglyze. But in 2014, AstraZeneca acquired all global rights to make and sell both of the type 2 diabetes drugs.
Thus, Onglyza heart failure lawsuits, as well as Kombiglyze heart failure lawsuits, can target AstraZeneca. That is an enormous global pharmaceutical company with British-Swedish operations and with headquarters in Cambridge, England.
How widely are AstraZeneca’s diabetes drugs used? In 2015, about 386,000 persons received a prescription for either of the saxagliptin-containing drugs — namely, Onglyza or Kombiglyze.
How trustworthy has AstraZeneca been with previous drugs that it’s made?
In 2010, AstraZeneca settled a lawsuit for $520 million after allegations that it defrauded U.S. government healthcare programs — including Medicaid and Medicare — regarding its marketing of Seroquel, a drug to treat bipolar disorder, schizophrenia and major depressive disorders.
The next year, AstraZeneca settled another lawsuit for $68.5 million, to be divided among many states.
FDA Cites Onglyza Risk Factors
Defective drug lawsuits can cite the FDA’s findings that the drugs’ have risk factors of hospitalization for heart failure.
The FDA says such risk factors for heart failure “include a history of heart failure or
renal impairment.” It says that a safety risk was found “in clinical trials among patients
with these medical issues.”
In assessing saxagliptin-induced heart failure, the FDA found that Onglyza and Kombiglyze seem to be the worst offenders.
The FDA cited one manufacturer-funded postmarketing clinical trial studying patients who had heart disease or were at high-risk for cardiovascular disease. That trial found a significantly raised risk of hospitalization due to heart failure in patients treated with saxagliptin drugs such as Onglyza and Kombiglyze.
Even so, the FDA advises that patients using Onglyza should not cease using the drug without consulting their healthcare professionals — a standard precaution for prescription drugs.
Such professionals, the FDA says, “should consider discontinuing the medicine in patients who develop heart failure and monitor their diabetes control. If a patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.”
Get an Onglyza Heart Failure Lawsuit
Victims of defective drug Onglyza can get an Onglyza heart failure lawsuit to protect their legal rights and gain financial recovery for injury losses. Your family may be legally entitled to substantial compensation for your medical costs, lost salary and pain and suffering due to an Onglyza heart failure injury.
Your Onglyza lawsuit not only can cite heart failure caused by the drug, but the fact that it was not properly tested before launch and was sold with insufficient warnings about Onglyza side effects.
Notify a defective drug lawyer with Jim Adler & Associates today and get a free and confidential legal review of your case — at obligation to you. Then you can decide if you want to seek payments for your injury losses with an Onglyza heart failure lawsuit.