Onglyza and Kombiglyze XR Heart Reactions
Onglyza and Kombiglyze XR, Type II Diabetes Drugs Associated with Serious Adverse Heart Reactions
The U.S. Food and Drug Administration (FDA) requested that the maker of the diabetes drugs, Onglyza and Kombiglyze XR (generic: saxagliptin)—AstraZeneca Pharmaceuticals LP and Bristol-Myers Squibb Company—to conduct a clinical trial to look into a potential tie between the use of these drugs and heart failure.
Incretin mimetic medications, such as Onglyza and Kombiglyze XR, two Type II diabetes medications have already been associated with various adverse health reactions, especially to the pancreas, including pancreatitis, which is a known precursor to pancreatic cancer.
Studies Tie Onglyza and Kombiglyze XR to Increased Hospitalization Rate for Heart Failure
The agency request followed release of a study published in the New England Journal of Medicine (NEJM) that revealed an increased hospitalization rate for heart failure when Onglyza and Kombiglyze XR are used. Heart failure is a cardiac condition under which the heart does not appropriately pump blood.
The drug maker is expected to provide trial data to the agency by early March 2014. At that time, the FDA will conduct a complete review and publicly report its findings. Although the FDA considers the NEJM data preliminary, review of the drug’s clinical trial data is part of a larger review of all Type 2 diabetes drug treatments and cardiovascular risks.
How Onglyza and Kombiglyze XR Work
Onglyza and Kombiglyze XR is used in conjunction with diet and exercise to reduce blood sugar in adults who are diagnosed with Type 2 diabetes by increasing the insulin produced by the body following meals, which is when blood sugar is at its highest.
When people are diagnosed with Type 2 diabetes, they maintain higher sugar, or glucose, blood levels as the body is unable to make or appropriately metabolize the hormone, insulin. When untreated, Type 2 diabetes may lead to serious and life-threatening health problems.
Incretin mimetics, are GLP-1-based diabetes therapies, that are made with natural substances that reduced increased blood sugar levels. The drug treatment is used in patients who have been diagnosed with unusually low insulin levels or in patients whose bodies are unable to efficiently utilize insulin. Incretin mimetics mimic, or imitate, the body’s incretin hormones. These hormones stimulate insulin release following meal consumption.
Studies Reveal Pancreas Harm to Onglyza and Kombiglyze XR, Other Incretin Mimetics
Studies have long associated Type 2 diabetes medications such as Onglyza and Kombiglyze XR, which are known as “incretin mimetics” to increased risks of developing pancreatitis.
Onglyza and Kombiglyze XR were among a number of drugs recently reviewed in a study that looked at adverse drug reaction reports (ADRs), according to researchers in Italy who confirmed the association between the medications and damage to the pancreas, according to a prior AdverseEvents report. Study results were published in the November 13, 2013 issue of Informa Healthcare.
The review involved data from the Italian Spontaneous Adverse Drug Reaction (ADR) Reporting Database that revealed relevant cases of ADRs associated with incretin mimetics. The researchers reviewed 1,169 reports involving incretin mimetics, including Onglyza and Kombiglyze XR. The review included 90 cases of pancreatitis or elevated pancreatic enzyme levels, according to the AdverseEvents report and the researchers concluded that the data verified an association between incretin mimetics and pancreatic impairment and recommended that patients taking incretin mimetics, such as Onglyza and Kombiglyze XR, should be monitored for potential pancreas injury.
Another published piece in the journal, BMJ, indicated that incretin mimetics, such as Onglyza and Kombiglyze XR, might be riskier than initially believed. That report also revealed that drug makers of incretin mimetics withheld information on the potentially dangerous effects of this class of drugs.
After reviewing thousands of pages of regulatory documents that were obtained under Freedom of Information rules, BMJ located unpublished data indicating that “unwanted proliferative or inflammatory pancreatic effects,” are associated with use of incretin mimetics.
Another study published March 22, 2013 in the journal, Diabetes, revealed abnormal changes, including pre-cancerous lesions, in the pancreases of eight people who had taken GLP-1-based medications, when compared with patients who took other diabetes medications, according to a prior report by Medscape Medical News.
Thousands of Adverse Event Reports Cite and Onglyza, Kombiglyze XR
Utilizing FDA Adverse Event Reporting System (FAERS) data received from November 1, 1997 to December 31, 2012 and aggregating and standardizing that data by the AdverseEvent RxFilter process, researchers discovered 4,512 reports of pancreatitis and 14 cases of elevated pancreatic enzyme levels in which incretin mimetics were indicated as the primary suspect. Of 4,512, the team identified 2,478 hospitalizations and 113 cases in which patients died and incretin mimetics were indicated as the primary suspect.
The FDA issued a Drug Safety Communication in March 2013 that indicated that it was “…investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes.”
Legal Help for Victims of Onglyza, Kombiglyze XR Type II Diabetes Medication
If you or a loved one sustained Onglyza- or Kombiglyze XR- heart failure, other related illnesses or death following use of these, or other, incretin mimetic medications, you may have valuable legal rights. We urge you to contact our Onglyza and Kombiglyze XR lawyers today by filling out our online form, or calling 1-800-YOURLAWYER (1-800-968-7529) today.