The History of Onglyza (Saxagliptin)
Onglyza (Saxagliptin) is an oral hypoglycemic drug used in the treatment of Type 2 diabetes. Onglyza is a DPP-4 inhibitor drug, which means an enzyme breaks down the incretin hormones. DPP-4 slows down the breakdown of incretin hormones, increasing those hormones in the body. This increase in incretin hormones is responsible for the beneficial actions of Onglyza (Saxagliptin), increasing insulin production in response to meals, and decreasing the rate of gluconeogenesis in the liver.
In 2016, the FDA added a warning on the labeling of Onglyza regarding the increased risk of heart failure. This warning was based on data from an article which concluded Onglyza (Saxagliptin) increased the rate for heart failure, and that while Onglyza improves glycemic control, other approaches could be necessary in reducing the cardiovascular risk among Onglyza (Saxagliptin) patients with diabetes.
Onglyza (Saxagliptin) is used as a monotherapy or in combination with other drugs to treat Type 2 diabetes (not Type 1 diabetes and not for ketoacidosis). It appears that patients taking Onglyza have about a 27 percent increased risk of hospitalization for heart failure, and the drug does not appear to decrease the risk of stroke or heart attack. However, like other DPP-4 inhibitors, the drug has a modest HbA1c lowering ability, and also has a relatively low risk of hypoglycemia.
The FDA received an application from AstraZeneca and Bristol-Myers Squibb for Onglyza in 2008, based on a drug development program with 8 randomized trials. Onglyza (Saxagliptin) was approved by the FDA in 2009, yet by 2012, adverse event reports were coming in to the FDA regarding Onglyza (Saxagliptin) risks and Onglyza (Saxagliptin) dangers.
Other DPP-4 Inhibitors Which Work Like Onglyza (Saxagliptin)
There are other drugs similar to Onglyza which are also DPP-4 inhibitors (Gliptins). Januvia (Sitagliptin) was the first DPP-4 inhibitor drug which worked by increasing levels of GLP-1 in the bloodstream, and Galvus (Vildagliptin) and Nesina (Alogliptin) came soon after. Onglyza (Saxagliptin), Kombiglyze (Saxagliptin mixed with metformin), and Tradjenta (Linagliptin) are the newest drugs in this family. The gliptin drugs are typically used for patients who have not responded to sulphonylureas or metformin.
Onglyza (Saxagliptin) Risks and Onglyza (Saxagliptin) Safety Problems
There are a number of serious, and less serious side effects associated with Onglyza. Inflammation of the pancreas (pancreatitis) can occur among those who take Onglyza—this inflammation can be severe and can potentially lead to death. Those who are taking Onglyza should tell their doctor if they have ever had gallstones, a history of alcoholism, high triglyceride levels or pancreatitis, and should contact their physician immediately if they experience severe abdominal pain which does not ease and feels as though it goes from the abdomen through to the back. Other Onglyza (Saxagliptin) safety problems which warrant an immediate call to a physician include:
- Shortness of breath;
- Difficulty breathing particularly when lying down;
- An unusually quick increase in weight;
- Fluid retention;
- Swelling in the feet, ankles or legs, or
- Unusual, persistent fatigue.
All of the above symptoms can be indicative of heart failure, therefore should be taken very seriously.
- Hypoglycemia (Low blood sugar) is another common Onglyza (Saxagliptin) risk and can be much more likely---and more serious—among those who currently take another diabetes medication, such as insulin or sulfonylurea. Symptoms of low blood sugar include sudden changes in vision, changes in mood, a rapid heartbeat, headache, sweating, extreme hunger, and shaking. Low blood sugar, if fairly mild, can be treated at home, however if your blood sugar is extremely low, have someone take you to the closest Emergency Room, and always tell your doctor if you are taking other diabetes medications.
- Joint pain is also fairly common among those taking DPP-4 inhibitors like Onglyza, and, in some cases, this joint pain can become severe. In fact, the FDA indicated that Onglyza (Saxagliptin)—and other drugs like it—can experience severe, even debilitating joint pain.
- A skin reaction, known as bullous pemphigoid, has been seen among those taking Onglyza (Saxagliptin). Bullous pemphigoid is an autoimmune skin disease which causes blisters and the breakdown of the outer layer of skin and requires hospitalization to treat the condition. In some cases, bullous pemphigoid can involve the mouth and nose linings. Treatment for severe cases of this condition caused by Onglyza include immune-suppression drugs, tetracycline, intravenous immunoglobulin infusions, and high-potency topical corticosteroids.
- Fluid retention which causes swelling in the ankles, hands or fee, can worsen among those taking Onglyza (Saxagliptin).
- “Common” Onglyza (Saxagliptin) side effects include:
- Upper respiratory tract infections;
- Flu-like symptoms;
- Chronic, worsening headaches;
- Urinary tract infections;
- Sore throat;
- Loss of appetite;
- Excessive fatigue, and
- Sudden weight gain or weight loss.
Allergic Reactions to Onglyza (Saxagliptin)
Some people who take Onglyza may have a severe allergic reaction to the drug. The symptoms of such a reaction include:
- Sudden swelling of the throat, lips or face;
- Difficulty swallowing or breathing
- Skin itching, flaking or peeling, and
- Hives or an unusual rash.
If the symptoms of an allergic reaction to Onglyza are experienced, stop taking the drug and contact a physician immediately, or go to the closest emergency room.
Serious Onglyza (Saxagliptin)l Dangers
There are a number of Onglyza (Saxagliptin) side effects which can be life-threatening, or even fatal. These include:
- Onglyza (Saxagliptin) Heart Failure—Although diabetes and heart failure frequently co-exist, after a study of 16,492 subjects with Type 2 diabetes was done (patients were given either Onglyza or a placebo), more patients who took Onglyza were hospitalized for heart failure, when compared with those taking the placebo. Those who have ever experienced prior heart failure or problems with their kidneys should talk to their doctor about these issues prior to taking Onglyza. Symptoms of heart failure include: increasing shortness of breath, difficulty breathing, particularly when lying down, a quick increase in weight, unusual tiredness and fluid retention and swelling in the ankles, legs or feet.
- Onglyza (Saxagliptin) Thyroid Cancer—Although the medical community has not yet reached a firm consensus, some research suggests the use of Onglyza could increase the risk of thyroid cancer. Cancer-related changes have been seen in the thyroid tissues of animal subjects treated with Onglyza. In human patients, dozens of cases of thyroid cancer have been reported among those being treated with incretin mimetics. In 2013, a group of doctors expressed concern about the potential cancer risks associated with DPP-4 drugs like Onglyza (Saxagliptin).
- Onglyza (Saxagliptin) Pancreatic Cancer—Researchers found evidence of pancreatic duct metaplasia among patients with Type 2 diabetes who were taking Onglyza, or a similar drug. Since Onglyza has been shown to increase the risk of pancreatitis, and pancreatitis has been found to be a precursor to cancer, it stands to reason that Onglyza could increase the risk for pancreatic cancer. Since November 2011, the warning label for Onglyza has included a notice regarding the risk of pancreatitis.
Could You Benefit from Speaking to an Onglyza (Saxagliptin) Injury Attorney?
If you have suffered injury after taking Onglyza (Saxagliptin), it could be beneficial for you to speak to a Sullo & Sullo Onglyza (Saxagliptin) injury lawyer to discuss your options. Perhaps you have experienced Onglyza (Saxagliptin) heart failure, Onglyza (Saxagliptin) thyroid cancer, Onglyza (Saxagliptin) pancreatic cancer, Onglyza (Saxagliptin) pancreatitis, or other Onglyza (Saxagliptin) side effects. If so, our Onglyza (Saxagliptin) injury attorneys will assess the facts of your case, determining whether it could benefit you to file an Onglyza (Saxagliptin) injury lawsuit to recoup your financial losses, including all medical expenses related to your Onglyza (Saxagliptin) injuries, lost wages and pain and suffering. Call the experienced Sullo & Sullo Onglyza (Saxagliptin) injury lawyers today.