The DrugNews facts: what you need to know.
Lawyers are helping those affected file Onglyza lawsuits.
Here are the answers to our most common questions!
Onglyza is a new diabetes medication prescribed more than 1.7 million times last year.
A recent Brigham and Women's/Harvard study found patients taking the drug more likely to be hospitalized for heart failure.
Despite FDA recommendations, the manufacturer of the drug has failed to properly warn patients of the heart failure risks.
So far, nearly 1,000 people have filed claims for heart disease in a special federal MDL court. Lawyers continue to help those affected.
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.
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.
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.
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.
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.
Consult with an attorney who specializes in the Onglyza litigation.
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