Product News and Recalls

FDA Panel Recommends Heart Warning for Onglyza

FDA suggests heart warning for onglyzaThe FDA is recommending that the pharmaceutical giant AstraZeneca include information about increased risk of heart failure on the label of its diabetes drug Onglyza.

An FDA advisory panel met on April 14 to discuss data linking AstraZeneca’s Onglyza, as well as Takeda’s diabetes drug, Nesina, to increased risk of hospitalization due to heart failure. According to Bloomberg, 14 of 15 panel members voted in favor of recommending that AstraZeneca add the heart failure data to its label, while 13 of 16 voted in favor of recommending that Takeda do the same.

onglyza may cause heart failureAstraZeneca previously put Onglyza through a 16,000-patient medical trial. The results of the study indicated that patients taking Onglyza were at greater risk of hospitalization due to heart failure than those not taking it. On April 10, the FDA found the results of this trial to be valid, and further identified a potential increased risk of death from all factors. According to the Reuters article, 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 was “not reassured” by the study, and would not dismiss the negative conclusions as chance findings.

Onglyza is not the only diabetes medication from AstraZeneca that has raised concern recently. The company’s incretin mimetic Byetta has also been the object of much scrutiny. 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 investigating Byetta and other incretins regarding links to increased risk of pancreatitis and pancreatic cancer. At the beginning of this year, nearly 600 Byetta/Januvia lawsuits had been filed in the Southern District of California as part of a multidistrict litigation. They have been centralized with other lawsuits involving Janumet, and Victoza.

Always be sure to check in with your doctor or physician when changing medications. If you or a loved one was diagnosed with pancreatitis or pancreatic cancer after taking Byetta or Januvia, contact the attorneys at Lopez McHugh for a free legal consultation. You may qualify for compensation through a Byetta or Januvia lawsuit.