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Dozens of Januvia Lawsuits Consolidated

Jul 9, 2013

Januvia lawsuits, brought on behalf of individuals who allege to have developed serious illnesses such as pancreatitis, and pancreatic and thyroid cancer, are rising nationwide.

Some 53 lawsuits, specifically citing a drug class known as incretin mimetics, drugs used in the treatment of Type 2 diabetes, have been federally filed and include lawsuits naming Januvia.

In addition to Januvia (sitagliptin), incretin mimetics include Byetta and Bydureon (exenatide); Victoza (liraglutide); Janumet, Janumet XR, and Juvisync (sitagliptin); Onglyza and Kombiglyze XR (saxagliptin); Nesina, Kazano, and Oseni (alogliptin); and Tradjenta and Jentadueto (linagliptin). Incretin mimetics include natural substances that lower raised blood sugar levels. Patients with Type 2 diabetes are either diagnosed with abnormally low insulin levels or their bodies do not utilize insulin efficiently. These drugs imitate the body’s incretin hormones, which stimulate insulin release after consuming a meal.

The federally filed Januvia lawsuits will be discussed by the United States Judicial Panel on Multidistrict Litigation on July 25th. At issue is whether to transfer the cases to a multidistrict litigation (MDL) in one federal court for pre-trial proceedings.

An MDL allows lawsuits associated with a particular product—in this case, the incretin mimetic Januvia—to be coordinated under one judge for pre-trial litigation. This process helps to avoid duplicative discovery and inconsistent rulings, and also helps to conserve the resources of the parties, witnesses, and the court. When lawsuits are consolidated as an MDL, each case retains its own identity. If the MDL process does not resolve the cases, they are transferred back to the court in which they originated for trial.

In the Januvia cases, the claims allege that the makers of this incretin mimetic drug neglected to provide sufficient warnings about the drug’s connecton with increased risks for serious adverse health reactions, including pancreatic and thyroid cancer and pancreatitis. Pancreatitis is painful, potentially fatal, and a known risk factor for pancreatic cancer. The disorder has also been linked to kidney failure.

Other serious side effects associated with incretin mimetics, such as Januvia, include low blood sugar; anaphylaxis and other allergic reactions, such as hives, rash, swelling of the face, lips, tongue, and/or throat; diseases of the pancreas such as acute, necrotizing, or hemorrhagic pancreatitis; vomiting and nausea; anorexia; persistent, severe abdominal pain, sometimes radiating to the back; and death.

A piece recently published in the journal BMJ, indicates drugs such as Januvia might be even riskier than initially believed. The journal report indicates that drug makers have withheld data on the potentially dangerous effects of incretin mimetics.

After analyzing thousands of pages of regulatory documents it obtained under Freedom of Information rules, BMJ located unpublished data indicating “unwanted proliferative or inflammatory pancreatic effects” associated with Januvia and other incretin mimetics. “On their own, the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug,” wrote Deborah Cohen, Investigative Editor for BMJ. Cohen added that drug makers have not conducted critical safety studies and regulators have never requested such studies, according to MedPage Today. She also noted that access has been denied to the raw data that would have shed light on the safety of incretin mimetics.

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