Jim Adler | The Tough, Smart Lawyer

Has someone in your family suffered heart failure or other injury after using defective type 2 diabetes drug Kombiglyze XR? If so, you deserve legal help. You deserve consideration for a Kombiglyze XR lawsuit in your behalf seeking payments for your injury losses.

Though approved by the U.S. Food and Drug Administration (FDA) in 2010 and sold ever since — with no Kombiglyze recall — the drug nonetheless has proven dangerous for some users, causing an increased risk of heart failure or congestive heart failure.

Victims have legal rights. Contact us today to explore your own.

FDA Warnings for Kombiglyze

Even though the FDA has not yet issued a Kombiglyze recall, the federal agency has issued FDA label warnings for the drug, as well as for comparable drug Onglyza, released in 2009 and made by the same manufacturer.

Both are type 2 diabetes medications designed to help the body control its level of blood sugar, or glucose. But they also can cause damaging side effects such as heart failure. These diabetes drug complications are due to each medication’s chief active ingredient, saxagliptin. No other drugs on the market have saxagliptin.

The FDA warnings added to the labels of Kombiglyze XR and Onglyza are designed to bring their potential for harmful side effects to the attention of consumers and healthcare professionals.

In an FDA Safety Alert issued on April 5, 2016, the agency warned that drugs containing saxagliptin (namely, Kombiglyze XR and Onglyza) “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.”

The FDA also warned of such dangers for three drugs containing alogliptin: Nesina, Kazano and Oseni.

Defective Drug Studies

Such warnings stemmed in part from defective drug studies showing raised risks of heart failure and other side effects among patients using Kombiglyze XR and Onglyza.

One study cited by the FDA was named Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus, also known as SAVOR. That study revealed a heightened risk of heart failure of more than 25 per cent among persons taking drugs with saxagliptin — namely, Kombiglyze XR or Onglyza.

Kombiglyze Complications Cited

Though Kombiglyze XR and Onglyza are comparable drugs, they are a bit different. For one thing, Kombiglyze XR also features metformin HCI (hydrochloride) extended release. As a result, in the FDA’s Medication Guide issued with Kombiglyze XR, it cites complications specific to that drug.

In citing “serious side effects” which can “happen in people taking Kombiglyze XR,” the FDA includes lactic acidosis. That is a rare but serious side effect involving a buildup of lactic acid in the blood, which can cause death.

“Lactic acidosis is a medical emergency and must be treated in a hospital, “ the FDA now warns in the packaging of Kombiglyze XR. It also urges urging patients to cease using the drug immediately if they suffer symptoms of the condition (including trouble breathing and an irregular heartbeat).

The FDA label warning for Kombiglyze XR also names the potential side effects of heart failure, a life-threatening condition, and inflammation of the pancreas (pancreatitis), “which can be severe and lead to death.”

Kombiglyze Recall Status

Yet despite its FDA Safety Alerts and its FDA warnings coming with Kombiglyze XR packaging, no Kombiglyze recall has yet been issued. Why?

The FDA often approves drugs without adequate clinical trials or sufficient data on their possible long-term side effects, which can take years to manifest. As a result, the post-release market for such drugs such as Kombiglyze XR becomes, in effect, a large clinical trial in itself.

When injuries do occur and are reported to the FDA, the agency conducts investigations into such drugs and, when determining the source and nature of their harmful side effects, may issue safety advisories as well as drug warnings on their labels.

If the problem persists and increases, the FDA may consider requesting a voluntary recall by the manufacturer (which, in the case of Kombiglyze XR and Onglyza, is British-Swedish company AstraZeneca). If that doesn’t work, the FDA may step in and demand a formal FDA recall for the drugs.

So far, one member of the FDA’s Advisory Committee has voted for an outright withdrawal of Kombiglyze XR from the market, asking for a complete recall. Eventually, such a recall may be issued by the FDA.

But even with no Kombiglyze recall, victims have a legal right to blame the drug’s manufacturer for their injuries and claim payments for their losses with a defective drug lawsuit.

Alert the law firm of Jim Adler & Associates of your injury today, and you will get a free legal review of your case that’s confidential and comes with no obligation to you. Then you can elect whether to proceed with a Kombiglyze lawsuit on your family’s behalf.

Target of Kombiglyze Lawsuits

The target of all Kombiglyze lawsuits should be the company which makes, markets and peddles the potentially destructive drug while reaping vast profits: AstraZeneca.

That company, based in Cambridge, England, has been solely responsible for Kombiglyze XR and Onglyza side effects since 2014, when it gained all world rights to produce and sell the drugs. Prior to that, it had joined with Bristol-Myers Squibb to research, develop and commercialize the two type 2 diabetes drugs before their approval and release in 2010 and 2009, respectively.

Today, nearly 400,000 persons use Kombiglyze XR or Onglyza, making them big money-makers for AstraZeneca. Yet despite clear evidence of serious side effects such as heart failure due to these drugs, the company has issued no recall and instead continues to rake in profits at innocent patients’ expense.

AstraZeneca has been in legal hot water already, for such things as a 2010 lawsuit’s allegations that it defrauded Medicare and Medicaid in marketing bipolar disorder drug Seroquel. The company settled that lawsuit for more than half a billion dollars.

Contact a Defective Drug Lawyer

Now knowing this, if someone in your family has suffered injury from using Kombiglyze XR, rest assured you can find legal help by contacting one of our defective drug lawyers.

For three decades, we have helped thousands of people get the money they legally deserved after being injured by someone else’s negligence. Let us help you, too, by claiming payments for your family’s medical bills, lost salary and pain and suffering due to defective drug Kombiglyze XR.

A Kombiglyze XR lawsuit may be just what your family needs — not only for financial recovery, but for justice and for your peace of mind.

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