Update: FDA to Investigate Onglyza / Rhabdomyolysis Link
December 1, 2017 – The U.S. Food & Drug Administration (FDA) is evaluating the need for regulatory action over Onglyza and other DPP-4 inhibitor diabetes medications after finding an increased risk of rhabdomyolysis with the drugs, according to a surveillance report issued October 4. Rhabdomyolysis is a severe medical condition characterized by the rapid destruction of skeletal muscle, which causes leakage into the urine of the muscle protein myoglobin.
What is Onglyza?
Onglyza (generic: saxagliptin) is an incretin mimetic oral medication that helps control blood sugar levels in patients with type 2 diabetes. The drug works by regulating the levels of insulin the body produces after eating. Onglyza is made by AstraZeneca, and was approved by the U.S. Food & Drug Administration (FDA) in July 2008.
What’s the Problem?
Onglyza belongs to a class of drugs called incretin mimetics. Januvia, the first incretin mimetic to be released in the U.S., is now listed on the FDA’s Do Not Use list. Galvus, another medication in this class, was rejected by the FDA over concerns about severe allergic reactions including Stevens-Johnson syndrome (SJS) and liver toxicity.
The consumer watchdog group Public Citizen noted that many people may have been confused about the proper use of Onglyza, which is designed only for controlling blood sugar levels in patients with type 2 diabetes. Larry Olson of Public Citizen stated “Some people may have believed that it would also decrease their risk of heart attack and stroke, while the exact opposite has proven to be true.” Other serious side effects linked to Onglyza include pancreatitis, thyroid / pancreatic cancer and renal failure.
Onglyza and Pancreatic Cancer
A study published in the March 2013 issue of Diabetes found pre-cancerous cells in the autopsied bodies of people who had taken type 2 diabetes drugs from the incretin mimetic class. According to the research, these types of medications increase the number and size of beta cells (cells that secrete insulin) in the pancreas. In type 2 diabetics, beta cells shrink or die and are unable to produce insulin.
The study’s authors confirmed that that the drugs did indeed increase the number of beta cells; however, the cells were determined to be abnormal. They also found small, benign tumors known as “adenomas” that can become malignant (cancerous).
Within weeks of the study being published, the FDA issued a Drug Safety Communication announcing that it would further investigate the potential link between Onglyza and pancreatic cancer.
“The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.”
Pancreatic Cancer Symptoms
- Abdominal pain
- Pale-colored stools
FDA has been investigating a potential link between incretin mimetics and thyroid cancer since at least 2009. In 2011, the agency published a Drug Safety Communication after studies indicated an elevated rate of malignant thyroid tumors in laboratory rats treated with Victoza.
Another study published in the journal Gastroenterology found that diabetes patients who used the incretin mimetic Byetta pen were almost 5 times more likely to develop thyroid cancer compared to those who took Avandia (generic: rosiglitazone).
Onglyza Heart Failure
In February 2014, FDA issued a Safety Alert regarding a clinical trial published in the New England Journal of Medicine (NEJM) that linked Onglyza to a 27% increased risk of hospitalization for heart failure. The agency said it would review data from the trial as part of a broader investigation into the heart risks of diabetes medications.
Symptoms of heart failure include:
- Congested lungs
- Fluid / water retention
- Dizziness / fatigue / weakness
- Rapid / irregular heartbeats (arrythmias)
FDA Issues Joint Pain Warning for DPP-4 Inhibitors
A class of diabetes medications that includes Onglyza has been linked to severe joint pain, according to an FDA warning issued August 28. The agency said it had identified 33 cases of joint pain in patients taking DPP-4 inhibitors from Oct. 16, 2006 through Dec. 31, 2013. Click here to learn more.
Bristol-Myers Squibb, AstraZeneca Sued for Onglyza Heart Failure
July 24, 2017 – A New Jersey man who claims that he developed coronary artery disease and congestive heart failure after taking saxagliptin has filed a products liability lawsuit against Bristol-Myers Squibb and AstraZeneca Pharmaceuticals. Plaintiff Earl Binns alleges that the drugmakers are responsible for his injuries because they had known for years that the diabetes drug could increase the risk of catastrophic heart damage.
MDL Proposed for Onglyza Heart Failure Lawsuits
Nov. 1, 2017 – A man alleging to have developed heart failure from the use of Onglyza has requested multidistrict litigation (MDL) status for his and all other similar claims. Plaintiff suggested the Northern District of California as the venue for the proposed litigation, noting that several cases have already been filed there, and that at least one plaintiff is based in San Francisco.
FDA Adds Heart Failure Warning to Onglyza Labeling
April 5, 2016 – The U.S. Food & Drug Administration (FDA) today announced new warnings to the labels of saxagliptin and alogliptin-containing type 2 diabetes medications. FDA said the drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” The announcement comes 2 years after an FDA panel recommended that the drugs’ labeling should be updated, but did not recommend any other harsher measures.
AstraZeneca Fails to Win Approval of New Combo Diabetes Drug
October 16, 2015 – AstraZeneca Plc failed to win U.S. approval for a new diabetes medication that combines dapagliflozin and saxagliptin after regulators asked for additional data that may require new clinical trials, according to Bloomberg News.
“This is clearly bad news for Astra,” said Sam Fazeli, an analyst with Bloomberg Intelligence. “It’s not clear how long they will have to wait.”
Skin Complications (Bullous Pemphigoid)
Nesina and other diabetes drugs from the DPP-4 inhibitor class have recently been linked to a rare skin disorder called bullous pemphigoid. Investigators at Western Michigan University, Kalamazoo, conducted a literature review and an analysis of the FDA’s Adverse Event Reporting System database and concluded there is a link between DPP-IV inhibitors and the development of bullous pemphigoid, a potentially fatal cutaneous autoimmune blistering disorder. The skin disease appeared after an average of 6 months on DPP-IV inhibitor therapy in their series. In most cases the condition remitted in response to discontinuation of the drug, often in conjunction with a course of topical or less frequently, oral corticosteroid therapy.
Onglyza was designed to improve the health and lifestyles of patients with type 2 diabetes mellitus. However, the risks of the drug may outweigh any potential benefits. Patients who have been injured by the side effects of Onglyza may claim that AstraZeneca:
- Failed to conduct adequate pre-market trials
- Failed to adequately warn patients and their healthcare providers about potential side effects
- Fraudulently and negligently marketed the drug
- Marketed the product despite having knowledge of inherent dangers
Texas Man Alleges Heart Failure from Onglyza, Kombiglyze XR
March 10, 2017 – A Texas man has filed a products liability lawsuit alleging that Onglyza and Kombiglyze XR caused him to develop heart failure. Plaintiff Wrendell Chester claims he took both drugs to treat his type 2 diabetes from 2010 to 2015, after which he suffered congestive heart failure, heart failure and acute hypoxic respiratory failure as a result of side effects of the medications.
Do I Have an Onglyza Class Action?
The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Onglyza Lawsuits. We are handling individual litigation nationwide and currently accepting new cancer and heart failure cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one developed cancer or heart failure after taking Onglyza, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.