The Problem: Claims have linked heart failure, pancreatic cancer and death to patients while taking the prescription Type 2 Diabetes drug, Onglyza.
The Response: The FDA has currently ordered more studies on these claims.
What Can We Do to Help: Our experienced attorneys can review your medical records and advise you if filing a case is in your best interest.
The attorneys at Gallon, Takacs, Boissoneault & Schaffer are investigating claims on behalf of Onglyza users who were hospitalized and/or diagnosed with heart failure, pancreatic cancer and death while taking the prescription Type 2 Diabetes drug, Onglyza.
Have you or anyone you know suffered from heart failure, pancreatic cancer or someone you know died while taking the prescription drug Onglyza? Find out if you are entitled to seek compensation by completing our free case evaluation.
The FDA has requested additional studies because it has been alleged there may be an association between use of Onglyza and an increased risk of heart failure.
What is Onglyza (Saxagliptin)?
Onglyza (Saxagliptin) was approved by the FDA in 2009 for use and manufactured and sold by Bristol-Myers Squibb & AstraZeneca Pharmaceuticals LP. Onglyza is an oral diabetes medication that helps control a diabetic’s blood sugar levels. It works by regulating the levels of insulin the body produces after eating. This drug belongs to a class of medications known as, incretin mimetics, which works by mimicking the incretin hormones that the body usually produces to naturally stimulate the release of insulin in response to a meal. This drug is intended for use by Type II Diabetics and is sometimes used in combination with other diabetes medications.
Since Onglyza’s approval in 2009, the FDA has updated the drug label on several occasions. The first update to the drug label came in November 2011; just 2 years after Onglyza hit the market. This update was to warn and advise of pancreatitis and hypersensitivity reactions. And once again, FDA updated the label just one (1) month later in December 2011 to include warnings and precautions for adverse reactions of hypoglycemia and confirmed this adverse reaction of hypoglycemia from a clinical trial in May 2013.
Heart Failure & Increased Death Risk
On December 8, 2008 FDA announced a new recommendation which was issued in its Guidance for Industry, Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type II Diabetes. This guidance, which is not legally enforceable, is to provide recommendations for the development of drugs and therapeutic biologics that are regulated within the Center for Drug Evaluation and Research at the FDA and is to specifically demonstrate that a new antidiabetic therapy to treat type II diabetes is not associated with an unacceptable increase in cardiovascular risk.
After a study was published in the New England Journal of Medicine in October 2013 and reported the increased risk of heart failure while taking Onglyza, on February 11, 2014 FDA requested the manufacturing company to complete clinical trials to investigate a possible association between Onglyza use and an increased risk of heart failure. In conclusion of the studies, on April 13, 2015, the FDA confirmed a possible increased risk of, (a) all-cause mortality, (b) heart failure and (c) death and requested for an updated drug label to include new risks.
Pancreatic Cancer Risk
Since the approval of Onglyza there have been a number of studies which have suggested that Onglza carries a risk of pancreatic cancer. According to the study published in the medical journal of Gastroenterology in February 2011, the study reported there is a 2.7 times greater chance of development of pancreatic cancer. Additionally, in the February 2013 study in the edition of JAMA Internal Medicine, researchers raised serious concerns on pancreatic cancer increase and use of diabetes drugs after finding that individuals were 2 times as likely to be hospitalized with severe cases of pancreatitis, which can sometimes lead to pancreatic cancer.
Serious Side Effects
- Heart Failure
- Pancreatic Cancer
- Thyroid Cancer
If you or anyone you know has taken or use Onglyza and have suffered any serious side effects such as heart failure, pancreatic cancer and even death, you may be entitled to compensation. The Onglyza attorneys at Gallon, Takacs, Boissoneault & Schaffer are dedicated to ensuring pharmaceutical companies are held responsible for the dangerous side effects of their products. Call our Onglyza Attorneys at Gallon, Takacs, Boissoneault & Schaffer or fill out the free case evaluation. We want to help you.