Januvia’s Link to Thyroid Cancer and Pancreatitis

Pancreatitis, pancreatic cancer and thyroid cancer may be just the tip of the iceberg regarding the type 2 diabetes drug, Januvia. Januvia safety concerns have increased steadily, almost from the time the drug received FDA approval in 2006. Between the time the drug was approved and February 9, 2009, the FDA received 88 reports of patients with acute pancreatitis, 75% of which required hospitalization. In over half of these cases, the patient’s pancreatitis resolved once they discontinued Januvia.

Is Januvia Pancreatitis a Precursor to Pancreatic Cancer?

Although diabetics are generally more susceptible to pancreatitis than the general population, studies show that there is an increased risk among those taking Januvia. Should the pancreatitis become chronic, the inflammation in the pancreas can alter the normal functioning of the pancreas and potentially lead to pancreatic cancer. The FDA revised Januvia’s prescribing information in 2009 and again in 2012 to include information regarding the potential of developing acute pancreatitis for those taking the drug.

Januvia (sitagliptin) is known as a dipeptidyl peptidase-4 (DPP-4) inhibitor. The drug works by mimicking the action of incretin hormones which are found in the gastrointestinal tract and stimulate the release of insulin following a meal. Recent research suggests a link between these incretin mimetics and the potential development of pancreatitis, pancreatic cancer and thyroid cancer. Although some experts argue the benefits of Januvia outweigh the risks involved, it is important to note that pancreatic cancer is one of the most deadly forms of cancer with a five-year survival rate of 4%.

Januvia Safety Concerns

The development of pancreatitis increases the overall risk of pancreatic cancer, therefore Januvia safety concerns appear to be significant. In fact, in the latest issue of Diabetes Care, Peter Butler, MD argued against the use of Type 2 diabetes drugs such as Januvia stating that while evidence of harm accumulates it is “vigorously discounted.” Dr. Butler went on to note that “We should be thankful that those responsible for aircraft safety do not operate on the assumption that the absence of evidence is evidence of absence.”

Risks of Januvia Thyroid Cancer

Januvia has also been shown to increase the proliferation of precancerous thyroid cells in rats, therefore the risk of Januvia users developing thyroid cancer may be higher than for the general population. A UCLA study, published in the journal Gastroenterology found a definite link between the use of Januvia and the development of pancreatitis and pancreatic cancer. This study placed the risk of developing pancreatitis among those taking Januvia at six times the normal risk.

Merck Sales Sluggish

Merck’s first quarter financial statements showed a drop in Januvia sales of four percent, compared to a sales growth of nearly fifteen percent in the previous quarter. Additionally, the FDA has asked Merck to update Januvia’s warning label to reflect the risks of pancreatitis, pancreatic cancer and thyroid cancer. The new labeling recommends that healthcare professionals carefully monitor Januvia patients for the development of pancreatitis and that for those with a history of pancreatitis Januvia should be used with extreme caution and regular monitoring.

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Do You Need Januvia Legal Representation?

When Dr. Peter C. Butler was asked by Merck to test its new diabetes drug, Januvia, on rats to determine whether it was safe, he initially declined. Eventually Dr. Butler changed his mind—a decision Merck & Co. likely regrets. Dr. Butler began testing Januvia on laboratory rats, finding changes in the rats’ pancreases which suggested a link to pancreatic cancer. By 2008—two years after Januvia obtained FDA approval—Dr. Butler had turned into a crusader against the drug. The follow-up studies done by Dr. Butler made him even more certain that Januvia could contain potential risk factors for the development of pancreatitis and pancreatic cancer. Dr. Butler noted that Januvia and other drugs containing sitagliptin work by increasing levels of a hormone known as glucagonlike peptide-1.

The increase in that hormone could well accelerate precancerous conditions which are already present in those in middle age. Just as the hormone estrogen appears to promote the growth of breast tumors, the glucagon hormone increased by Januvia could give cells just the “hit” they need to turn cancerous. Based on Dr. Butler’s studies, both the FDA and the European Medicines Agency began investigations which could lead to new warnings on Januvia. At this point over forty lawsuits have been filed against Merck & Co., regarding harm suffered from Januvia. The National Institutes of Health will hold a two-day meeting on possible links between diabetes drugs and pancreatic cancer and Dr. Butler is scheduled to speak at that meeting.

Getting Januvia Legal Help

Those who took Januvia and developed a serious illness could benefit from speaking to a qualified attorney to discuss a Januvia lawsuit and potential Januvia damages. From the time Januvia was approved by the FDA in 2006, 88 adverse reports came in from those taking the drug and suffering from pancreatitis by 2009. More adverse reports came in after those initial cases which prompted the FDA to require Merck to increase the warnings on Januvia labeling, first in 2009 and later in 2012. If you believe you developed pancreatitis, pancreatic cancer or thyroid cancer as a result of taking Januvia, it’s important that you consider seeing an attorney. Preserving your Januvia claim is extremely critical at this juncture as you may have large amounts of medical expenses, lost wages and pain and suffering as the result of a drug you believed to be safe.

Januvia Statute of Limitations

Once you speak with a qualified Januvia attorney, you will likely more fully understand how your Januvia claim will proceed. A competent Januvia attorney will conduct a thorough assessment of your right to file your Januvia case and lay out your options. The statute of limitations can range from one year to five years, depending on which state you live in, although the typical statute is two years. Texas has a two-year statute of limitations and it is extremely important that this deadline be met in order to protect your right to file your Januvia case. If a drug has been recalled, then the statute of limitations is clear, however Januvia has not been recalled therefore it may be more difficult to determine when the statute began to run. An experienced and knowledgeable Januvia attorney may be able to help you even if the statute has passed on your particular case, but he or she will need to know the particular circumstances of your case.