What’s the Problem?
In 2011, the consumer watchdog group Public Citizen raised questions about the potential serious side effects of Onglyza, a recently-approved type 2 diabetes drug. In their monthly newsletter, Worst Pills Best Pills, the group urged consumers to wait seven years, or until 2016, before they use Onglyza so that more long-term data is available about its potential risks and benefits. Even though the drug only hit the market in 2009, Onglyza has already been closely scrutinized by the FDA. The administration has requested that drugmaker Bristol-Myers Squibb conduct post-marketing studies, and has expressed concerns about the drug’s heart risks, liver toxicity, and potential skin reactions.
Onglyza was approved for the treatment of type-2 diabetes, and belongs to a class of medications known as incretin mimetics. The first drug from this class, Januvia, is listed on Public Citizen’s ‘Do Not Use’ list. Another incretin mimetic called Galvus has been approved in Europe but was rejected by the FDA due to concerns about liver toxicity and severe allergic reactions, including Stevens-Johnson Syndrome (SJS).
Additionally, Public Citizen noted that Onglyza is only designed for managing blood sugar levels in type 2 diabetics, and that some have mistaken this to mean that the drug will reduce the risk of heart attack and stroke. However, Onglyza and other incretin mimetics are only intended to treat diabetes symptoms, like frequent urination and thirst. No type 2 diabetes drug on the market is allowed to say that it can reduce the risk of heart attack or stroke.
Onglyza Side Effects
Serious side effects associated with Onglyza include:
- Pancreatic Cancer
- Thyroid Cancer
- Heart Failure
- Acute Pancreatitis
- Hemorrhagic Pancreatitis
- Necrotizing Pancreatitis
- Kidney Complications
- Renal Failure
Other, less severe Onglyza side effects may include:
- Allergic reactions including hives, difficulty breathing, and swelling of the face, lips, tongue, or throat
- Unexplained muscle pain or weakness
- Joint pain
- Memory problems
- Unusual tiredness
- Dark colored urine
- Weight gain
- Urinating less than usual or not at all
- Severe pain in the upper stomach spreading to your back
- Loss of appetite
- Fast heart rate
- Increased thirst
- Increased urination
- Dry mouth
- Fruity breath odor
- Dry skin
- Blurred vision
- Weight loss
- Dark urine
- Clay-colored stools
- Jaundice (yellowing of the skin or eyes)
- Severe skin reactions
- Sore throat
- Swelling in the face or tongue
- Burning in they eyes
- Skin pain
Diabetes Drugs, Pancreatitis & Pancreatic Cancer
Recent studies have found an increased risk of acute pancreatitis in diabetes patients treated with incretin mimetic drugs. One such study, published in Feb. 2013 by Dr. Sonal Singh of Johns Hopkins University School of Medicine and Public Health, found a doubled risk of pancreatitis for incretin mimetic users.
“Since most risk factors for acute pancreatitis are also linked to an increased risk of pancreatic cancer, these findings of changes in the human pancreas are very concerning,” said Dr. Singh.
A month after these findings were published, another study from researchers at UCLA and the University of Florida found that incretin mimetics cause abnormal pancreatic growth in humans that may be linked to neuroendocrine tumors, which could increase the risk of pancreatic cancer. The researchers found an approximately 40% increase in cell mass in the pancreases of deceased organ donors who had taken the drugs. The increase in size of the pancreases was associated with increased cellular proliferation, including an abnormal form of cell proliferation, which is a risk factor for pancreatic cancer.
FDA Warning on Incretin Mimetic Pancreatic Cancer Risk
On March 14, 2013, the FDA issued a Drug safety Communication announcing that it had launched an investigation into the link between incretin mimetic diabetes drugs and pancreatic cancer. The agency said it will review academic researchers’ findings and asked researchers to provide the methodology they used to collect and study specimens which showed pancreatic damage so that it could further investigate potential health risks associated with the medications.
Which Diabetes Drugs are Incretin Mimetics
In addition to Onglyza, other incretin mimetics include:
- Byetta (exenatide)
- Bydureon (exenatide)
- Janumet (metformin and sitagliptin)
- Janumet XR (sitagliptin and metformin HCl extended-release)
- Januvia (sitagliptin)
- Jentadueto (linagliptin and metformin)
- Kazano (alogliptin and metformin)
- Kombiglyze XR (saxagliptin and metformin)
- Nesina (alogliptin)
- Oseni (alogliptin and pioglitazone)
- Tradjenta (linagliptin)
- Victoza (liraglutide)
Pancreatic Cancer Symptoms
- Jaundice (yellowing skin and/or whites of eyes)
- Upper abdominal pain
- Digestive difficulties
- Unexplained weight loss
- Ascites (excessive fluid buildup in the abdominal cavity that causes swelling and distention of the belly)
Studies Link DPP-4 Inhibitors to Bullous Pemphigoid
A study published in Dermatology in 2016 looked at 3 cases of DPP-4 inhibitor use associated with bullous pemphigoid (BP), a rare skin disorder that causes skin rashes and blistering on the legs, arms and abdomen. All 3 patients showed a clear temporal relationship between DPP-4 inhibitor therapy and onset of the condition. One case was due to Tradjenta use, while the other 2 cases were linked to a combination of Galvus / vildagliptin-metformin.
In October 2016, FDA asked DPP-4 manufacturers to include a pemphigoid warning to their medication’s labeling. All manufacturers complied by January 2017, the agency said.
Onglyza Heart Failure Lawsuits Centralized in Kentucky
February 5, 2018 – JPML has voted to consolidate all federal lawsuits alleging heart failure injuries from Onglyza and Kombiglyze XR for pretrial handling in the Eastern District of Kentucky. The Panel issued an Order transferring all such claims to the Kentucky court, which will be overseen by the Honorable Karen K. Caldwell.
Onglyza May Increase Risk of Rhabdomyolysis
December 1, 2017 – Patients who took Onglyza and other medicines from the DPP-4 inhibitor class have been diagnosed with a severe muscle disorder called rhabdomyolysis, according to a recent FDA Warning. The agency is determining whether the drugs’ risks outweigh their benefits, and will notify the public as the information becomes available.
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 heart damage.
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.
Study Highlights Risk of Combining Onglyza with Other Diabetes Drugs
June 23, 2016 – A new study published in the British Medical Journal (BMJ) has found that combining DPP-4 inhibitors like Onglyza with diabetes drugs in the “sulphonylurea” class may increase the risk of hypoglycemia (low blood sugar), a life-threatening condition. The researchers cautioned that physicians should “respect recommendations for a decrease in sulphonylureas dose when initiating DPP-4 inhibitors.”
Onglyza Labels Updated to Include Heart Failure Warning
April 5, 2016 – Type 2 diabetes drugs containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients with a history of heart or kidney disease, according to an FDA Drug Safety Alert issued today. As a result of these problems, new warnings will be added to the labeling of all saxagliptin and alogliptin-containing medications. The findings are from an evaluation of 2 large clinical trials which found that more patients were hospitalized for heart failure who received DPP-4 diabetes drugs compared to those who took a placebo.
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, 2015.
Chicago Woman Blames Diabetes Drug for Mother’s Death
A lawsuit filed in Cook County Circuit Court alleges that Onglyza caused the death of a woman due to heart failure. The complaint, filed by her daughter under case number 2015-L-010969, seeks a trial jury and damages of more than $50,000 including interest, attorney fees and punitive damages.
Patients who have been injured by Onglyza side effects may allege that AstraZeneca:
- Failed to conduct sufficient pre-market trials
- Failed to adequately warn doctors and patients about potential side effects
- Fraudulently or negligently marketed the drug
- Marketed Onglyza despite having knowledge of inherent dangers
Has a Class Action Been Filed?
Although we are a nationally recognized class action firm, the Products Liability Litigation Group at Schmidt & Clark, LLP, has decided against the filing of an Onglyza Class Action Suit, and is currently filing individual claims on behalf of individuals and/or their family members who developed cancer or heart failure after using Onglyza.
The problem with class actions is that people with very serious injures are lumped in together with people who are not as seriously injured. Even if members are awarded compensation, everyone typically divides the payout equally — after lawyers’ fees. The result is often a “low-ball” settlement with high attorneys’ fees.
Do I Have an Onglyza Lawsuit?
The Pharmaceutical 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 investigating potential settlements in all 50 states.
Again, if you developed pancreatic 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.