Onglyza Risks and Lawsuits
Onglyza, a Type-2 diabetes medication, faces mounting lawsuits in response to patient injuries and an increased risk of death from heart failure. Litigation against the medication is still in its early stages as the U.S. Food and Drug Administration (FDA) continues to collect research data on the associated risks.
Onglyza (saxagliptin) is manufactured by AstraZeneca Pharmaceuticals and was approved by the FDA in 2009. It's typically prescribed to diabetic patients and meant to be used with proper dieting and exercise. The drug is designed to control high blood sugar and prevent:
- Kidney damage
- Nerve issues
- Sexual health problems
- Limb amputation.
Saxagliptin Side Effects
While Onglyza has several FDA-labeled and known risks, there are also unlabeled risks and side effects which are being linked to the drug. The labeled side effects include:
- Potentially lethal pancreatitis (pancreatic inflammation)
- Serious allergic reaction, (swelling face, lips, throat, or skin; difficulty swallowing or breathing; hives, rash, itching, flaking, or peeling skin)
- Low blood sugar (hypoglycemia) from taking other diabetes medications
- Swelling or fluid retention from taking other diabetes medications containing thiazolidinedione
- Upper respiratory tract infection
- Urinary tract infection
- Severe joint pain
- Heart failure
Pancreatitis, heart failure, and severe joint pain were not included in product labeling when the medication was first released. The FDA added subsequent warnings after it received these post-market reports:
- In November 2011, the FDA required an update to package labeling to include pancreatitis as a side effect.
- In March 2013, the FDA announced its investigation into reports of pancreatitis and pancreatic cancer. Results have yet to be published.
- In August 2015, another label update added severe joint pain.
- In April 2016, another label update added risk of heart failure.
Onglyza litigation is still in its infancy as allegations continue to develop. As of June 2016, one lawsuit was filed against AstraZeneca over the wrongful death of a diabetic patient. The lawsuit claims that AstraZeneca failed to warn the public about Onglyza's heart failure risk at the time of the patient's prescription in 2010.
More lawsuits against AstraZeneca may focus on side effects developed before any of Onglyza's label updates. AstraZeneca could face personal injury/wrongful death claims that predate the 2011, 2015, and 2016 label updates. It may also see claims regarding Onglyza's alleged risk of pancreatic cancer since the risk hasn't yet received a labeled warning.
However, plaintiffs may face difficulty arguing Onglyza's heart failure risk due to conflicting study results. Three trials measured the risk and returned with contrasting data. AstraZeneca may try to use the newer, more favorable results to argue against the heart failure risk.
Get Legal Help
For most people suffering from unlabeled Onglyza medication side effects, the hospitalization and surgical treatment costs can be devastating. There is also the risk of becoming impaired and losing valuable work time or ability.
If you've suffered from any of these hardships, consult with a verified Onglyza attorney. An experienced attorney can review your case and provide you with options and assistance in getting your money back.
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