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A ‘gliptin’ drug singled out for FDA scrutiny


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Since February, the U.S Food and Drug Administration has been investigating a potential link between the use of the diabetes drug saxagliptin and heart failure. AstraZeneca Pharmaceuticals LP and Bristol-Myers Squibb Company have marketed saxagliptin as the brand-name drugs Onglyza and Kombiglyze XR.

Already studying the cardiovascular risk profile of type-2 diabetes drugs, the FDA took the additional step in February of requesting from Bristol-Myers Squibb clinical trial data to assist in the agency’s investigation of “a possible association between use of the type-2 diabetes drug and heart failure.”

“FDA’s request,” the agency wrote in its safety alert, “resulted from a study published in the New England Journal of Medicine, which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment.”

Onglyza and Kombiglyze XR, along with the diabetes drug Januvia, were already under FDA scrutiny for their association with serious pancreatic disorders.

Since March 14, 2013, the agency has been “evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics,” a group that includes sitagliptin (Januvia, Janumet, Janumet XR, Juvisync) and saxagliptin (Onglyza, Kombiglyze XR).

“These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes,” the FDA’s statement reads.

The U.S. Judicial Panel on Multidistrict Litigation has centralized incretin mimetics lawsuits before one judge at the U.S. District Court for the Southern District of California. There are more than 300 such lawsuits, which include Januvia lawsuits, pending there.

The panel wrote in one of its 2013 transfer orders, “Plaintiffs in all actions allege that the use of one or more of four anti-diabetic incretin-based medications – Janumet (sitagliptin combined with metformin), Januvia (sitagliptin), Byetta (exenatide) and Victoza (liraglutide) – caused them or their decedent to develop pancreatic cancer.”

With 30 years of experience in trying cases against pharmaceutical corporations, the skilled product liability attorneys at Reich & Binstock fight for victims of incretin mimetics. Anyone who has taken one of the four key diabetes drugs and who has developed pancreatic cancer is a victim Reich & Binstock wants to help. The firm also will ensure that justice is served for the families of the deceased.

Rest assured, the experienced attorneys at Reich & Binstock also will monitor the examination of a relationship between using Onglyza and Kombiglyze XR and heart failure. They will be well-prepared to protect the right to compensation for these and for any other pharmaceutical injury victims.

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