Onglyza is a drug approved by the FDA to treat type 2 diabetes. The product, when taken as prescribed, has shown significant benefits for patients. However side effects can be quite dangerous and unexpected.
The “onglyza 5 mg side effects” is a common side effect of Onglyza. The list includes nausea, diarrhea, and abdominal pain.
Onglyza (saxagliptin) is a type 2 diabetes medicine that lowers blood sugar levels in people. Kombiglyze XR, an extended-release version of the medication, is also available (saxagliptin and metformin). AstraZeneca manufactures both, and both have been linked to an elevated risk of heart failure, heart attack, cardiovascular damage, and even death.
Despite worries about potential cardiovascular hazards, the Food and Drug Administration (FDA) authorized Onglyza.
In a follow-up research after Onglyza was authorized, it was shown that Onglyza patients were 27 percent more likely than a control group to be hospitalized for heart failure. Onglyza users also showed a significant rise in “all-cause mortality,” according to the research.
Onglyza has been on the market since 2009, however the relation to heart failure was not revealed until 2014. Millions of individuals had already been prescribed the medicine by that time.
You may be able to bring a lawsuit against AstraZeneca if you or a loved one was hospitalized or died while using Onglyza.
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About Saxagliptin and Diabetes
Type 2 diabetes medications Onglyza and Kombiglyze XR have been authorized by the FDA. In the United States, diabetes has reached epidemic proportions, impacting 29 million individuals. Type 2 diabetes is responsible for 90-95 percent of all adult diabetes occurrences.
Insulin is not used adequately by people with type 2 diabetes. When food is digested, it is converted into sugars by the body (glucose). Insulin, a hormone that instructs cells to absorb and store glucose, is also produced by the body. Because type 2 diabetics do not make enough insulin, their cells are unable to absorb glucose, causing blood glucose levels to increase above normal. This may harm the body over time and lead to a variety of health problems.
Diabetes drugs, in combination with diet and exercise, may help persons with type 2 diabetes regulate their blood sugar levels.
Onglyza and Kombiglyze XR are DPP-4 (dipeptidyl peptidase IV) inhibitors, which are a kind of diabetic treatment.
DPP-4 is an enzyme that degrades incretin, a gut hormone. The pancreas produces more insulin as a result of incretin. DPP-4 inhibition prolongs incretin’s stay in the body, activating insulin release and reducing blood sugar levels.
Onglyza (authorized in 2009) and Kombiglyze XR (approved in 2010) are two medications in the “incretin mimetics” category. These medications were heralded as “the new darlings of diabetes therapy” and the “greatest advance since the discovery of insulin” when they first arrived.
However, growing safety worries about the medications have given medical specialists pause.
The FDA has issued a warning about the risk of Onglyza causing heart failure.
In April 2016, the FDA released a medication safety statement stating that new labels for Onglyza and Kombiglyze XR will be added to warn of the risk of heart failure.
The new warning warnings come a year after an FDA panel examined Onglyza’s safety data and recommended that the medicine be labeled with information regarding the risk of heart failure. The SAVOR research, which included 16,000 patients, found that Onglyza patients had a 27 percent higher chance of heart failure hospitalization.
Overall, 3.5 percent of saxagliptin patients required hospitalization due to heart failure.
A analysis of the data revealed that Onglyza patients had a considerably higher risk of all-cause mortality (death from any cause).
Fourteen of the fifteen members of the FDA panel decided to change the Onglyza label to reflect the elevated risk of heart failure. The other member voted to remove Onglyza off the market totally in the United States.
Heart failure occurs when the heart does not pump as much blood as it should. Among the signs and symptoms are:
- During everyday tasks, you may experience shortness of breath.
- While laying down, you may have shortness of breath.
- Weakness and exhaustion
- Legs, feet, and ankles are swollen.
- Difficulty concentrating/confusion
- Fluid retention causes weight growth.
- Heartbeats that are fast or irregular
Joint Pain that is Severe
DPP-4 inhibitors, including as Onglyza and Kombiglyze XR, were cautioned by the FDA in August 2015 that they might induce severe and debilitating joint pain. To reflect this danger, new labels have been applied to the medications.
Hundreds of complaints were filed with the FDA’s adverse event reporting system, prompting the agency to modify its labelling. Patients reported significant joint pain effects from one day to many years after starting a DPP-4 inhibitor, according to the FDA. Fever, chills, rash, and edema were noted by around a third of the patients. In other instances, the pain was severe enough to need hospitalization.
Symptoms faded when patients stopped using the medicine for less than a month, but returned in some patients who initiated a DPP-4 inhibitor.
Pancreatitis and Cancer of the Pancreas
Onglyza received a pancreatitis warning in 2011 as a result of post-marketing reports of acute pancreatitis in individuals using the medicine. Concerns have also been raised concerning the medication’s relation to pancreatic cancer, a danger that the FDA highlighted in a 2013 drug safety warning alongside pancreatitis.
The FDA’s announcement was based on academic studies suggesting that patients on incretin mimetics (a class of medicines that includes Onglyza) had a higher risk of pancreatitis.
Pre-cancerous cellular alterations were also discovered in the pancreases of individuals taking these medicines, according to the researchers.
Drugs like Onglyza have been linked to pancreatic impairment in studies published in JAMA and BMJ.
In 2014, the FDA and the European Medicines Agency (EMA) concurred that there was no conclusive evidence linking incretin-based medications to pancreatitis or pancreatic cancer. However, the authorities emphasized that it was too soon to rule out a causative link between the medications and pancreatic issues.
DPP-4 inhibitors are associated with a statistically significant elevated risk of acute pancreatitis, according to a meta-analysis of three large clinical studies presented at the World Diabetes Congress 2015.
Based on an examination of a long-term research presented at the American Diabetes Association (ADA) 2015 Scientific Sessions in Toronto, no causal association between saxagliptin and cancer-related mortality was found — nor was it ruled out. The results were restricted by the relatively small number of particular cancer types and the short follow-up period, according to the study’s chief researcher, Dr. Lawrence A. Leiter.
Abdominal discomfort, nausea, and vomiting are symptoms of pancreatitis, but pancreatic cancer symptoms include:
- Eyes and skin develop a yellowish color (jaundice)
- Light, oily stools and/or dark urine
- Back or abdominal discomfort
- Weight reduction that was unintentional
- Vomiting and nausea
- Diabetes is becoming worse.
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Thyroid Cancer is a kind of cancer that affects the
In animal research, the diabetic medicine Victoza (liraglutide), which is an incretin mimic like Onglyza and Kombiglyze XR, has been related to thyroid cancer. The FDA says the research’ relevance to people is uncertain, but it has ordered the maker to put up a register to track such instances and has cautioned physicians to watch for thyroid cancers in their patients.
Side Effects of Kombiglyze XR
Kombiglyze XR has the same health concerns as Onglyza since it has the same active component (saxagliptin). Lactic acidosis is a potential side effect of Kombiglyze XR, which also includes the drug metformin hydrochloride.
Lactic acidosis is a dangerous build-up of lactic acid in the blood. Although this is a well-known adverse effect of Kombiglyze XR, patients should be aware of symptoms such as weakness, weariness, trouble breathing, muscular discomfort, slow or irregular heartbeat, and dizziness.
Lawsuits involving Onglyza and Kombiglyze XR
We can assist if you or a loved one developed heart failure, had a heart attack, had a cardiovascular injury, or died while on Onglyza.
We are one of the country’s biggest and most prestigious law companies, and we have a lot of expertise with matters like this.
During a free case assessment, find out whether you qualify for legal action and receive answers to your concerns.
The “onglyza contraindications” is a list of common side effects that may be experienced by patients taking Onglyza.
Frequently Asked Questions
What is the best time of day to take Onglyza?
A: The best time to take Onglyza would be in the morning.
Does Onglyza cause joint pain?
A: No, Onglyza is not associated with joint pain.
Does Onglyza cause weight gain?
A: Research is still inconclusive, but we have found that Onglyza can cause weight gain in some cases.
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