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A panel of expert advisors to the FDA is recommending that new warning labels be added to the diabetes drug Nesina, indicating that side effects may include an increased risk of heart failure.
In a 13 to 3 vote, members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee determined that the stronger warnings were required, but the panel did not recommend additional restrictions on the drug. The same panel voted to add similar heart failure warnings to Onglyza, a related diabetes drug sold by AstraZeneca.
Nesina (alogliptin) is a Takeda Pharmaceuticals medication approved in 2013 for treatment of diabetes. The drug is part of a class of incretin mimetics, known as DPP-4 inhibitors, which also include Onglyza and Merck’s Januvia.
The FDA advisory panel made its decision based off the results of a clinical trial known as EXAMINE. With similar warnings added to the drug Onglyza, some members of the panel raised the possibility about a potential risk of heart problems with Nesina and an increased risk of death that may be associated with side effects of all DPP-4 inhibitors.
The results of a clinical trial on Januvia, known as the TECOS trial, are expected in June.
The FDA advisory panel determined that the potential heart risks were not severe enough to warrant restrictions or a Nesina recall, but urged new warnings. While the panel’s recommendations are not binding on the FDA, they are usually factored into any regulatory actions taken by the agency.
A report released a year ago by AdverseEvents.com found that out of a number of fairly new diabetes drugs, Nesina appears to be the one with the highest percentage of adverse events by doctors and patients. However, they noted that could be an effect of the actual low Nesina sales numbers at the time. Januvia and Janumet actually had the highest number of actual complaints, but they also have very large sales numbers.
The study also looked at pancreatic cancer concerns with incretin mimetic diabetes drugs, finding that the adverse event reports support recent claims that the medications pose an carry risk of pancreatitis and pancreatic cancer, despite some reports which say there is no increased risk.
AdverseEvents.com found that DPP-4 inhibitors, which include Janumet, Januvia and Nesina, had “high disproportionality results for both pancreatitis and pancreatic cancer.”
A number of Byetta lawsuits, Januvia Lawsuits, Janumet lawsuits and Victoza lawsuits are currently pending in courts throughout the country involving similar incretin mimetic diabetes drugs, alleging that the makers of those medications failed to adequately warn about the risk that users may develop pancreatic cancer.
The incretin mimetic litigation pending throughout the federal court system has been consolidated as part of an MDL, or Multidistrict Litigation, which is centralized before U.S. District Judge Anthony J. Battalglia in the Southern District of California to reduce duplicative discover, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.