LAWSUITS NEWS & LEGAL INFORMATION

Januvia Pancreatic Cancer, Januvia Thyroid Cancer FAQ

What is Januvia and how does it work?

Januvia is an oral diabetes medicine made by Merck for people with type 2 diabetes. It is the brand name for sitagliptin - the active ingredient contained in Januvia, which is an incretin mimetic and in the class of diabetes drugs known as DPP-4 (dipeptidyl peptidase-4 inhibitors). DPP-4 is a protein in the body involved in glucose metabolism.

Januvia works by regulating the levels of insulin your body produces during digestion. It mimics the action of the hormone incretin, which is released in the gut and stimulates the pancreas to increase insulin production. Januvia inhibits DPP-4 that is normally released while you eat to suppress insulin levels to regulate the glucose levels in the blood.

What are Januvia’s serious side effects?

Many type 2 diabetes patients taking Januvia have experienced dangerous side effects and injuries including pancreatitis, acute pancreatitis, acute hemorrhagic pancreatitis, acute necrotizing pancreatitis and acute renal (kidney) failure.

Type 2 diabetes patients taking Januvia have an increased risk of developing pancreatic cancer, which is difficult to diagnose in the early stages. Thyroid cancer is also associated with Januvia.

Hypersensitivity side effects have included Stevens-Johnson Syndrome, which can be life-threatening.

How can Januvia be associated with cancer?

Studies have shown that, because Januvia inhibits DPP-4, it may also limit the body’s natural defense against the spread of cancerous cells.

Many cases of acute pancreatitis have been reported, and it can lead to Januvia pancreatic cancer. Januvia patients have more than two times a higher risk of developing this cancer, and the risk increases the longer the patient is using the drug. The average rate of survival for someone living with pancreatic cancer is 18 to 20 months, according to the American Cancer Society.

What Januvia side effects are attorneys investigating?

Attorneys are investigating and accepting claims of Januvia pancreatitis, Januvia pancreatic cancer and Januvia thyroid cancer. You may be eligible to file a Januvia cancer lawsuit if you took the diabetes drug for at least three months and were later diagnosed with pancreatic cancer or thyroid cancer.

Why is there concern about Januvia now?

There are 26 million people in the US with type 2 diabetes - a 10 percent increase in three years. According to Dr. Sidney Wolfe of the Health Research Group at Public Citizen, pharmaceutical companies are rushing to supply the demand and some critics say that safety issues are put aside in their hurry to get the drug to market.

What do studies say about Januvia side effects?

Studies have shown that Januvia and other similar drugs used to treat type 2 diabetes have been linked to pancreatic and thyroid cancers.

One study conducted by researchers at UCLA concluded that taking Januvia increases the patient’s risk of developing pancreatitis six times more than those taking other diabetic medications.

In 2011, a study in Gastroenterology reported a 2.7-fold increase in reported pancreatic cancers among Januvia patients. Two cases of thyroid cancer were also reported.

In March 2013, a study found incretin mimetics like Januvia might cause changes in pancreatic cells that could lead to cancer. This study resulted in the FDA opening a safety review of the drugs, and from the consumer group Public Citizen to demand a Januvia recall.

In June 2013, a report in BMJ (British Medical Journal) indicated that the manufacturers of incretin mimetics may have downplayed their serious side effects, including pancreatitis, pancreatic cancer, and thyroid cancer. The authors called for stronger warnings on the drugs’ labels, and said that further study of their effects on the pancreas and thyroid is needed.

A report by AdverseEvents, a California-based company that analyzes post-market side effect data, says that Janumet and Januvia showed elevated signals for both pancreatitis and Januvia pancreatic cancer

What is Merck accused of?

Januvia lawsuits accuse Merck of failing to provide adequate warnings about the drug’s link to increased risks of pancreatitis, pancreatic cancer and thyroid cancer. Lawsuits also allege that the giant drug company knew, or should have known, about these dangers.

According to recent allegations in Januvia lawsuits, Merck has:

• Failed to issue a Januvia recall after it became clearly apparent that the serious risks outweigh the potential benefits provided over safer alternative medications to control diabetes;

• Failed to advise the medical community about the necessity of monitoring patients for signs or symptoms that the pancreas was changing; and

• Failed to adequately warn physicians and their patients about Januvia’s potential side effects, including pancreatic cancer or thyroid cancer.

Are there any other diabetes medications linked to pancreatitis and cancer

Yes, other diabetes drugs have been linked to acute pancreatitis and pancreatic cancer, such as Byetta and Victoza. Janumet (sitagliptin and metformin hydrochloride) carries a black box warning concerning lactic acidosis. The metformin in Janumet builds in the blood causing lactic acid to accumulate faster than it can be removed. Janumet has also been linked to kidney problems requiring dialysis treatment.

In March 2013, the FDA health advisory announced that officials were conducting an investigation into the following incretin mimetic drugs:

exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).

Who will I be suing if I file a Januvia lawsuit? I don’t want my doctor involved.

Merck & Co. is the manufacturer of Januvia and the primary defendant in Januvia product liability lawsuits. Doctors are not being named as defendants in Januvia lawsuits. Instead, Januvia lawsuits allege Merck hid Januvia’s risks from patients and physicians.

A Januvia product liability claim is based on the following:

• There was a duty of care owed by the manufacturer of Januvia to warn of dangers associated with the product’s expected and normal use;

• There was a failure in the duty of care owed by the manufacturer of Januvia; and

• The failure resulted in an injury or death related to the use of Januvia.

Have Januvia lawsuits been filed?

Many Januvia lawsuits are pending nationwide, but as of July 2014, none have gone to trial and Merck has not reached any settlements with plaintiffs. Attorneys speculate that it will likely take several years before Merck settles any Januvia cases: As of August 2013, the litigation surrounding incretin mimetics (a class of drugs that includes Januvia) was just beginning to get underway.

By February 2014, more than 300 incretin mimetics cases had been consolidated in multidistrict litigation (MDL) before a federal judge in San Diego. The Januvia MDL was approved by a federal judiciary panel because of common allegations that the diabetes medications may cause pancreatic cancer.

One lawsuit filed by a Connecticut woman alleges Januvia caused her to develop pancreatic cancer and she has suffered severe physical, economic and emotional injuries as a result of using Januvia. The lawsuit alleges that “Defendants concealed their knowledge that Janumet, can cause life threatening pancreatic cancer from Plaintiff, other consumers, the general public, and the medical community. Indeed, the manufacturers of Januvia and Janumet do not even mention pancreatic cancer in their drug’s respective product inserts.”

Is there a Januvia class-action lawsuit?

Not currently. However, consolidated litigations are proceeding in California and New Jersey.

How much time do I have to file a Januvia lawsuit?

States differ in their statute of limitations. Attorneys advise Januvia patients to seek legal help as soon as you believe that Januvia is related to your illness. You could lose your rights to compensation if you fail to file a lawsuit within the statute of limitations.