Update: FDA Requires New Heart Failure Warning on Nesina
April 5, 2016 – Type 2 diabetes medications containing saxagliptin (Onglyza) and alogliptin (Nesina) may increase the risk of heart failure, the U.S. Food & Drug Administration (FDA) announced today. The warning comes after an FDA advisory committee voted last year that new labeling information should be added to these 2 dipeptidyl peptidase-4 (DPP-4) inhibitors; the agency said the decision follows its evaluation of a pair of large clinical trials of patients with type 2 diabetes and heart disease who took the medications.
Nesina (generic: alogliptin) is a prescription incretin mimetic drug used as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. The medication works by increasing levels of incretins, natural substances in the body that control blood sugar by increasing insulin release, especially after a meal. Nesina is made by the Takeda Pharmaceutical Company, and was approved by the U.S. Food & Drug Administration (FDA) on January 25, 2013.
What’s the Problem?
Despite their considerable effectiveness as a treatment for diabetes, incretin mimetics like Nesina have been linked to reports of serious side effects including pancreatitis, pancreatic cancer and thyroid cancer. Many people who have suffered from these side effects have filed lawsuits against drugmakers seeking compensation for their injuries. Complaints allege that the companies sold the medicines despite knowing they were dangerous, and failed to warn the public and medical communities about their risks.
Nesina Side Effects
- pancreatic cancer
- thyroid cancer
- acute pancreatitis
- hemorrhagic pancreatitis
- necrotizing pancreatitis
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 June 2011, the FDA issued a Drug Safety Communication after researchers found that laboratory rats who were given clinically relevant doses of Victoza (generic: liraglutide) — another diabetes drug from the incretin mimetic class — developed malignant C-cell thyroid tumors. Although it is unclear whether this risk translates to human patients, or whether Nesina has a similar risk, both drugs influence GLP-1 and could potentially increase the risk of thyroid cancer.
Then in March 2013, FDA issued another a Drug Safety Communication regarding incretin mimetics and pancreatitis. According to the warning, researchers found “pre-cancerous cellular changes called pancreatic duct metaplasia” in the pancreases of deceased people who had taken the medications to treat their type 2 diabetes. Although the FDA could not conclude definitely whether incretin mimetics increase the risk of pancreatic cancer, pancreatitis is a known risk-factor for full-blown pancreatic cancer.
Do I Have a Nesina Class Action Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Nesina lawsuits. We are handling individual litigation nationwide and currently accepting new pancreatic cancer and heart failure cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by Nesina side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.