ATTENTION: ONGYLZA PATIENTS DIAGNOSED WITH CARDIOVASCULAR INJURIES YOU MAY BE ELIGIBLE FOR AN ONGLYZA LAWSUIT AND SUBSTANTIAL COMPENSATION If you took Onglyza for type-2 diabetes and took the drug as directed and suffered from Onglyza side effects: specifically:heart failure, death or another serious cardiovascular injury, after starting Onglyza therapy, contact Nashville Onglyza lawyer Timothy L. Miles today to see if you are eligible for an Onglyza lawsuit and possibly entitled to substantial compensation.
If you suffered Onglyza Side Effects contact Nashville Onglyza lawyer Timothy L. Miles, you could be eligible for an Onglyza lawsuit
What is Onglyza?
Manufactured by AstraZeneca, the U.S. Food and Drug Administration (FDA)-approved drug Onglyza (saxagliptin) is used for treating Type 2 diabetes and is a part of the DPP-4 inhibitor class of medications. Its goal is to lessen glucose levels and diabetic complications for adults with Type 2 diabetes. However, the FDA has cautioned that taking Onglyza may be linked to an elevated risk of congestive heart failure. In light of this, the FDA advisory committee has suggested that the medication’s label should be changed to include a warning regarding heart failure risk. It is not listed as a controlled substance.
If you or somebody you know has experienced heart failure or death due to taking Onglyza, or suffered other serious Onglyza side effects, you may be eligible for an Onglyza lawsuit. Contact Nashville Onglyza lawyer Timothy L. Miles today for a free case evaluation to see if you meet the requirements for an Onglyza lawsuit and are eligible for an Onglyza lawsuit and possibly entitled to substantial compensation.
Why Did the Original Onglyza Label Not contain a heart failure warning?
In 2008, the FDA suggested that drug companies should assess the cardiovascular hazards of Type 2 diabetes medications more thoroughly during development. AstraZeneca attempted to include a statement in Onglyza's prescribing information that saxagliptin could be related to a diminished risk of cardiovascular events, but the FDA declined this due to a lack of clinical evidence.
This same lack of data caused the FDA to demand additional post-approval testing of Onglyza, which was followed up with a New England Journal of Medicine (NEJM) study in 2012 that showed a heightened danger of heart failure in Onglyza users. Pre- and post-market testing of Onglyza demonstrate significant disparities. For instance, clinical trials had a median of 62 weeks (1.19 years) of testing, while the post-marketing study had patients for a median of 2.1 years. Instead of conducting more thorough testing of Onglyza prior to FDA approval, AstraZeneca waited until after the drug was authorized. As a result, thousands of patients may have been exposed to increased risks of heart failure and death and potentially other serious Onglyza side effects as a result of the failure to warn.
why should users of onglyza be concerned?
Type 2 diabetes patients who take Onglyza may be at increased risk for a specific type of cardiovascular complication: heart failure. Onglyza users may also face a higher risk of death overall due to Onglyza side effects.
These risks are based on a 2013 study published in the NEJM which found that, compared to a placebo, saxagliptin resulted in a 27% increase in the rate of patient hospitalization for heart failure. The study also found that saxagliptin users had increased risk for all-cause mortality.
Based on the NEJM study findings, the FDA convened a meeting of its Endocrinologic and Metabolic Drugs Advisory Committee in April 2015 to assess the heart failure risk of Onglyza. 14 of 15 committee panelists voted for an updated Onglyza label that warns about the risk of increased heart failure. One panel member voted to withdraw Onglyza from the U.S. market.
What are the onglyza side effects?
The most common Onglyza side effects include:
Anxiety
bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
blurred vision
body aches or pain
chills
cold sweats
confusion
cool, pale skin
cough
depression
difficult, burning, or painful urination
difficulty with breathing
dizziness
ear congestion
fast heartbeat
fever
frequent urge to urinate
headache
increased hunger
loss of voice
lower back or side pain
nasal congestion
nausea
nightmares
rapid weight gain
runny nose
seizures
shakiness
slurred speech
sneezing
sore throat
tingling of the hands or feet
unusual tiredness or weakness
unusual weight gain or loss
In addition, Pancreatitis (swelling and inflammation of the pancreas) may occur while using Onglyza, along with the risk of heart failure.
what is the problem with onglyza?
Research shows Onglyza and other similar drugs may put patients at risk of heart complications. Dozens of patients are filing lawsuits against Onglyza's manufacturer AstraZeneca and its previous partner Bristol-Myers Squibb alleging that the companies failed to adequately test the drugs’ safety prior to selling it, which ultimately caused their cardiovascular injuries.
DOES onglyza PUT PATIENTS AT RISK OF HEART FAILURE?
A clinical trial funded by AstraZeneca and Bristol-Myers Squibb was one of the first studies to report cardiovascular health risks associated with these drugs.
Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus, or the SAVOR trial, found that patients with a history of heart problems who took Onglyza or Kombiglyze XR had a 27% greater chance of being hospitalized for heart failure than patients who took a placebo. Patients with chronic kidney disease and / or previous heart failure were more likely to be hospitalized. When an FDA panel reviewed the results from the SAVOR study, 14 out of 15 panelists voted to require a safety warning on all Onglyza and Kombiglyze XR bottles that the drugs could result in cardiovascular injury.
Patients are filing lawsuits against AstraZeneca and Bristol-Myers Squibb alleging that Kombiglyze XR caused their cardiovascular injuries. Complaints allege that AstraZeneca and Bristol-Myers Squibb failed to adequately test the drug prior to their sale.
In February 2018, more than 80 Onglyza and Kombiglyze XR lawsuits were centralized in Lexington, Kentucky. Plaintiffs' attorneys said that centralization is key to reducing inconsistencies since these lawsuits were "just the tip of the iceberg" and the number of filed complaints was expected to grow.
In a complaint filed in January 2018, Illinois plaintiff Jerald Adams alleged that after being exposed to saxagliptin after taking both Onglyza and Kombiglyze XR, the diagnosis of his heart failure was “directly related to taking these drugs.”
In the complaint, Mr. Adams alleged that the manufacturers not only knew of the cardiovascular injury risk associated with saxagliptin, but that they also failed to warn or mitigate this risk despite their knowledge.
"At all relevant times, defendants had knowledge that there was a significantly increased risk of adverse events associated with saxagliptin, including heart failure, congestive heart failure, cardiac failure, and death related to those events, and despite this knowledge, defendants continued to manufacture, market, distribute, sell, and profit from sales of saxagliptin," the complaint alleges.
Some lawsuits filed in New Jersey claim that Bristol-Myers and AstraZeneca did not just do a poor job of testing the safety of their drugs, but that they also did not conduct the clinical trials recommended by the FDA in 2008 prior to Onglyza’s sale debut in 2009.
In 2008, the FDA Endocrinologic and Metabolic Drugs Advisory Committee "determined that concerns about cardiovascular risk should be more thoroughly addressed during drug development." Bristol-Myers and AstraZeneca failed to do so and began marketing Onglyza in 2009.
what are the allegations in the onglyza lawsuits?
Onglyza lawsuits allege that AstraZeneca and Bristol-Myers Squibb failed to:
Warn the FDA, the medical community, and the general public of the cardiovascular risks associated with these drugs.
Conduct adequate pre-clinical and clinical testing to determine if the drugs caused increased risks of cardiovascular injuries.
Design the drugs so as to minimize certain adverse effects.
Conduct adequate post-market monitoring of saxagliptin’s adverse events
what are some specific case examples?
Dennis Turner: Mr. Turner took Onglyza from September 2012 to August 2015. In October 2014, he suffered congestive heart failure and filed a lawsuit on December 12, 2017.
John Wesley Hunt: Mr. Hunt took both Onglyza and Kombiglyze XR from September 2015 to April 2017. He suffered myocardial infarctions and congestive heart failure and filed a lawsuit on October 25, 2017.
Wilma J. Sextonz: Ms. Sextonz took Kombiglyze XR from December 2011 to July 2018 and suffered heart failure after taking the drug. She filed a lawsuit on August 22, 2018.
SHOULD I REPORT ANY onglyza SIDE EFFECTS?
Yes, the FDA urges consumers who experience adverse advents to any medication or product to report it via the MedWatch Online Voluntary Reporting Form. When reporting your Onglyza side effects make sure to be through and give as many details as possible about your experience taking the drug including all Onglyza side effects you suffered, and any other symptoms you suffered that you believe were caused by Onglyza use.
Additionally, the FDA also advises individuals that they may safely dispose of any unused Onglyza at a neighborhood drug takeback location and provides instructions on how to safely dispose of the drug if there are no nearby takeback centers, as well as what to do with your medicine that has been exposed to heat, such as fire, on unsafe water.
WHAT IS An onglyza LAWSUIT?
An Onglyza Lawsuit is a demand, or claim, from the defendants for monetary compensation by patients who took Onglyza and subsequently developed Onglyza Side Effects including cardiovascular injuries. The lawsuits allege the defendants made a defective drug and failed to warn physicians about its carcinogenic properties. If you suffered Onglyza Side Effects and are eligible for an Onglyza lawsuit, you may possibly be entitled to substantial compensation. A Nashville Onglyza Lawyer can answer these questions, including the stages of the lawsuit, and is available anytime just give us a call or submit the form below for a free case evaluation to see if you are eligible for an Onglyza lawsuit.
HOW DO I KNOW IF I AM ELIGIBLE fOR An onglyza LAWSUIT?
If you or a loved one took Onglyza as directed and suffered from heart failure or other cardiovascular injuries—such as congestive heart failure or myocardial infarction, after starting Onglyza therapy, you may meet the requirements for an Onglyza lawsuit and possibly be entitled to substantial compensation. Call a Nashville Onglyza lawyer for free today who can tell you if you are eligible for an Onglyza lawsuit.
IF I MEET THE REQUIREMENTS FOR An onglyza LAWSUIT, WHAT CAN I GET?
If you meet the requirements for an Onglyza lawsuit and are successful you can recover money for some of the following damages: • Past and future medical bills (including medication, hospital stays, and in-home care) • Pain and suffering • Lost wages • Loss of earning capacity • Funeral expenses (in the event of a loved one’s death) Broadly speaking, a plaintiff who is meets the requirements for an Onglyza lawsuit and is eligible for an Onglyza lawsuit could be entitled to compensation for any past and future costs associated with their diagnosis if they meet the requirements for an Onglyza lawsuit and are successful. If your case proceeds to trial it is also possible the court could impose punitive damages, intended to punish the defendant for their actions.
what can a nashville onglyza lawyer do for me?
Because of the complexity of the cases and the need to hire experts, a products liability attorney is the go-to attorney when you have been injured by a drug or a product that is defective like Onglyza. A Nashville OnglyzaLawyer, who is an experienced products liability attorney, can help you by putting you in the best possible position to win your Onglyza Lawsuit and recover the most compensation if you are eligible for an Onglyza Lawsuit.
IF YOU BELIEVE YOU ARE ELIGIBLE FOR An onglyza LAWSUIT, KEEP ALL YOUR onglyza DOCUMENTATION
Maintaining all your Onglyza documentation and other evidence is critical if you believe you are eligible for an Onglyza lawsuit. You will need this evidence to prove your case and that you are entitled to compensation in an Onglyza lawsuit. Your Nashville Onglyza lawyer will determine what evidence best supports your claim, but you should maintain and start gathering all your Onglyza documents if you believe you are eligible for an Onglyza lawsuit, including:
All your medical records, including bills, doctor notes, receipts, and any other notes or documents.
Receipts and any other documents including dosage information relating to your Onglyza prescription.
All bank and other records evidencing your payments for doctor visits, prescriptions, medical tests and anything else you had to pay for in relation to your Onglyza prescription.
Any communications from the FDA or any other governmental agency concerning your Onglyza Side Effects.
If a doctor, nurse, or any other health care provider made any comments regarding your Onglyza Side Effects, write them down while they are still fresh on your mind and get a witness statement if possible.
Any other relevant documentation or evidence you believe supports your claim that Onglyza caused your heart failure or other cardiovascular injuries or other Onglyza Side Effects.
IF YOU SUFFERED FROM onglyza SIDE EFFECTS, CALL A NASHVILLE onglyza LAWYER TO SEE IF YOU ARE ELIGIBLE FOR An onglyza LAWSUIT
If you or a loved one took Onglyza as directed and suffered from Onglyza Side Effects, specifically: heart failure or other cardiovascular injuries—such as congestive heart failure or myocardial infarction, after starting Onglyza therapy, contact Nashville Onglyza lawyer Timothy L. Miles today to see if you are eligible for an Onglyza lawsuit and possibly entitled to substantial compensation.
While there is still time to file a lawsuit, be mindful that these cases are time-sensitive, and give us a call today.
See if you are eligible for a ONGLYZA lawsuit
Fill out the contact form below for a free case evaluation with a Nashville Onglyza lawyer to see if you are eligible for a Onglyza lawsuit and possibly entitled to significant compensation. The call is free and so is the fee unless we will you case, so fill out the form today and see what a Nashville Onglyza lawyer can do for you.
FREE CASE EVALUATION: SEE IF YOU ARE ELIGIBLE FOR AN ONGLYZA LAWSUIT
If you took Onglyza and suffered serious cardiovascular injuries, call today for a free, no obligation case evaluation with Nashville Onglyza Lawyer Timothy L. Miles to see if you are eligible for an Onglyza Lawsuit and possible compensation.
ATTENTION: ONGYLZA LAWSUIT If you took Onglyza for type-2 diabetes and took the drug as directed and suffered from Onglyza side effects: specifically:heart failure, death or another serious cardiovascular injury, after starting Onglyza therapy, contact Nashville Onglyza lawyer Timothy L. Miles today to see if you are eligible for a Onglyza lawsuit and possibly substantial compensation.
Nashville OnglyzaLawyer 855-Tim-M-Law (855) 846-6529 [email protected] Call Nashville Onglyza lawyer Timothy L. Miles today for a free case evaluation and see if you meet the requirements for an Onglyza lawsuit and may possibly be eligible for substantial compensation.
