Product News and Recalls

FDA: AstraZeneca’s Diabetes Drug Onglyza May Pose Increased Risk of Death

onglyza may cause risk of heart failureA new FDA report has concluded that AstraZeneca’s new diabetes drug Onglyza may be associated with an increased risk of death, Reuters reports.

This is not the first time AstraZeneca has come under scrutiny for its anti-diabetic drugs. As early as 2008, the FDA began receiving reports of hemorrhagic and necrotizing pancreatitis developing in patients taking AstraZeneca’s incretin mimetic drug Byetta, used to treat type 2 diabetes. In 2013 the FDA began conducting investigations into Byetta and other incretins regarding links to increased risk of pancreatitis and pancreatic cancer. By the end of 2014, nearly 600 Byetta lawsuits had been filed in the Southern District of California as part of a multidistrict litigation.

fda warns of risks with onglyzaAnother incretin mimetic called Januvia has also drawn attention for its links to pancreatic cancer. Merck was recently hit with a lawsuit filed on behalf of a Georgia resident who died from pancreatic cancer. This lawsuit has been centralized along with others concerning Byetta, Janumet, and Victoza in the multidistrict litigation ongoing in the Southern District of California.

AstraZeneca previously put Onglyza through a 16,000-patient medical trial. The results of the study showed that patients who took Onglyza were more likely to be hospitalized for heart failure than those who did not take it. According to the Reuters article, the FDA identified a potential increased risk of death due to all causes. Although causes of death were found to be “multifactorial”—resulting from combinations of new as well as pre-existing health conditions—the FDA said that it is “not reassured” and does “not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance.”

Be sure to consult your doctor or health care provider whenever changing medications. If you or a loved one was diagnosed with pancreatitis or pancreatic cancer after taking Byetta or Januvia, contact Lopez McHugh’s pharmaceutical attorneys now for a free consultation. You may be eligible to receive compensation through a Byetta or Januvia lawsuit.