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ONGLYZA HEART FAILURE LAWSUITS

Manufacturer fails to warn of reports that Onglyza users more likely to suffer heart failure.

SEE THE SIDE EFFECTSthe litigation

Heart problems after using Onglyza?

IN SHORT

  • What patients need to know about Onglyza.

  • Studies linking Onglyza to patient side effects.

  • FDA heart failure warnings.

  • Pending Onglyza side effects lawsuits.

TYPE 2 DIABETES DRUG

Onglyza is a new DPP-4 inhibitor medication for type 2 diabetes that was prescribed more than 1.7 million times in the United States last year.

STUDIES & FDA WARNINGS

A recent Brigham and Women's/Harvard study found those taking Onglyza more likely to be hospitalized for heart failure. Despite FDA recommendations, the manufacturer of the drug has failed to warn patients of the heart failure risks.

HEART FAILURE LAWSUITS

Lawyers have begun filing lawsuits on behalf of those patients who suffered heart problems after taking Onglyza. Contact us to speak with a lawyer today at no cost.

onglyza lawsuit

What is Onglyza?

Onglyza is the brand name for saxagliptin, an oral prescription medication prescribed to help patients with type 2 diabetes control their blood sugar levels. It is available as a coated tablet in 2.5 and 5 mg doses, and is taken once daily.

Onglyza was developed jointly by the drug companies Bristol-Myers Squibb and AstraZeneca, and is now sold by AstraZeneca. It was approved by the FDA on July 31, 2009.

Onglyza belongs to a class of diabetes drugs called DPP-4 inhibitors, which also includes Januvia and Nesina. These drugs work by increasing the production of incretin hormones that block the action of the pancreatic hormone glucagon. This raises insulin levels while reducing blood glucose levels.

Onglyza may be prescribed alone or in combination with other diabetes medications. It is not intended to treat type-1 diabetes.

Assistance is available. Speak with a patient advocate today.

What Are the Onglyza Heart Failure Risks?

On October 3, 2013, the New England Journal of Medicine published a study completed by researchers at Harvard Medical School and Brigham and Women's Hospital in Boston that followed more than 16,000 patients taking either Onglyza or a placebo for around 2 years.

The study, known as SAVOR, found that patients taking Onglyza were 27% more likely to be hospitalized for heart failure. Researchers noted that, while Onglyza helped control blood sugar, patients would need other methods to reduce cardiovascular risk.

In addition, FDA records show that, to date, the agency has received adverse event reports showing 113 patients taking Onglyza suffered heart failure, heart attack or heart disease, as well as 46 reports of patient death.

ONGLYZA: THE STATS

INCREASED RISK OF HEART FAILURE - 27%
PATIENT DEATHS REPORTED TO THE FDA - 46 PEOPLE
HEART PROBLEM REPORTS TO THE FDA - 113 PEOPLE
PRESCRIPTIONS EACH YEAR - 1.7 MILLION

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FDA Onglyza Heart Failure Warnings

On February 11, 2014, in response to the results of the SAVOR study, the U.S. Food and Drug Administration announced it was opening an investigation into the heart failure and death risks of Onglyza.

Following a review of Onglyza data, the FDA convened a panel of experts in April of 2015 that expressed concern over increased rates of death and heart failure among patients taking the drug.

Ultimately, the panel voted 14-1 in favor of recommending that AstraZeneca, who sells Onglyza, add label warnings to notify patients of possible increased risks of heart failure.

So far, AstraZeneca has failed to make any changes to the Side Effects, Medication Guide, or warning label of Onglyza to include any mention of heart failure risks.

Onglyza Side Effects

The Medication Guide from the maker of Onglyza lists a number of possible side effects, including:

In addition, the label warns of possible allergic reactions from Onglyza, including:

However, the Medication Guide contains no information about the SAVOR clinical study conducted by the manufacturers, or the possible risk of heart failure.

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HEART FAILURE

heart failure onglyza

DIFFICULTY BREATHING

heart attack after onglyza

PANCREATITUS

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HEADACHE

Onglyza Lawsuits

Although the makers of Onglyza have known for years that the drug may be linked to an increased risk of heart failure, and the FDA has recommended they add heart failure warnings, they have failed to do so.

So far, the FDA has received more than 150 reports of patients suffering death or heart problems while taking Onglyza. And, with experts predicting less than 30% of cases are reported, the actual number of serious heart side effects could be higher.

Now, lawyers are helping those affected by heart failure or death of a loved one from Onglyza use file lawsuits to recover their losses.

In October, the first Onglyza lawsuit was filed in Chicago, Illinois, by the family of a woman who died from heart failure after taking the drug.

According to court documents, Lillie Ree Gibson took Onglyza for her type-2 diabetes for approximately 3 years. She was hospitalized twice and eventually died of heart failure, which has been linked to her prescription drug.

The lawsuit, filed by her daughter, is case number 2015-L-010969.

Due to the popularity of Onglyza and failure of the makers to warn of the risks, lawyers believe thousands of patients may ultimately be effected. They expect the compensatory damages for those victims and their families could be substantial, and that cases will eventually be consolidated to a central federal court for quicker handling.

DrugNews works only with lawyers and law firms that specialize in drug injury cases like Onglyza heart failure. To speak directly with a lawyer at no cost, contact us today.

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Scirica, B., et al. Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus. New England Journal of Medicine. (October 3, 2013). Retrieved from www.nejm.org

FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR). (February 11, 2014). Retrieved from www.fda.gov

Staton, T. Onglyza's label should flag heart failure risks, FDA panel says. (April 14, 2015) retrieved from www.fiercepharma.com

FDA Briefing Material. NDA 22350: Saxagliptin (Onglyza). (April 2015). Retrieved from www.fda.gov

Possible Side Effects of Onglyza. AstraZeneca. (March 4, 2016). Retrieved from www.onglyza.com

Hadley, R. Daughter sues AstraZeneca, alleging diabetes drug caused motherís heart failure. Cook County Record. (November 4, 2015). Retrieved from www.cookcountyrecord.com