Sunday, June 30, 2013

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.

Thursday, June 27, 2013

Januvia FDA Stance and Warnings

Januvia (sitaglipin) is a drug used in the treatment of Type 2 diabetes, and manufactured by Merck & Co. The FDA approved Januvia for sale in the United States in 2006, yet within the next three years had received 88 reports of pancreatitis from Januvia users. Sixty-six of those submitting adverse reports were hospitalized due to the severity of the illness. Nineteen of the Januvia patients had been taking the drug for a month or less. The FDA required Merck to increase the warnings regarding pancreatitis, pancreatic cancer and thyroid cancer on the labeling of Januvia first in 2009, then again in 2012. Despite the FDA safety concerns and the fact that the agency seems to believe Januvia may be linked to an increase in the incidence of pancreatitis, pancreatic cancer and thyroid cancer there has been no Januvia recall as of yet.

Januvia may be used alone or in combination with other anti-hyperglycemic drugs such as metformin. Januvia is in a class of drugs known as incretin mimetics which essentially mimic the body’s own production of insulin in those with Type 2 diabetes. A recent report in the JAMA Internal Medicine Journal showed Januvia patients were at a much higher risk—as much as two times that of those not taking the drug—of developing pancreatitis as compared to those who took other drugs to control their Type 2 diabetes. A UCLA study put the numbers even higher; stating those taking Januvia had six times the risk of developing pancreatitis and 2.9 times the risk of developing pancreatic cancer.

Pancreatitis can be serious, or even life-threatening and pancreatic cancer is considered to be one of the most deadly forms of cancer. Those patients who suffer chronic pancreatitis may have a higher risk of developing pancreatic cancer. Another study concluded that those taking sitaglipin could be at a higher risk of thyroid cancer as well. The FDA is currently declining to definitively state that Januvia and other drugs like it could be responsible for the development of pancreatitis or pancreatic cancer and are simply advising Januvia patients to continue taking the drug until they have had a chance to speak with their doctor regarding the potential risks.

Merck brought in $3.3 billion dollars from sales of Januvia in 2012 alone, although it appears revenues are down approximately 4% in the first quarter of 2013. Even so, the company is still making huge profits from a drug which may be dangerous or unsafe. While the FDA ordered Merck & Co to conduct a safety study on rats to determine whether Januvia was responsible for a higher incidence of pancreatic cancer or pancreatitis. The study was meant to be concluded and reported to the FDA by 2011, yet by February, 2012 the FDA sent a warning to Merck to conclude the study and get the report in.  By all accounts the study has not yet been concluded or reported.

A serious illness can devastate a family; medical bills pile up and the person who is sick may be unable to work and bring home a regular paycheck. It could be beneficial for those harmed by taking Januvia to look into whether a lawsuit is advisable.


Sullo & Sullo, LLP prides itself on being a client-focused law firm. With a reputation for exceptional personal attention, unmatched professionalism, zealous advocacy, and a commitment to the utilization of innovative and interactive technologies, our firm has been able to serve over 160,000 clients for more than a decade.  We wish you the best in your pursuits and encourage you to engage our firm for legal representation. For more information, visit Sullolaw - Januvia Dangers

Wednesday, June 26, 2013

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.


Sullo & Sullo, LLP prides itself on being a client-focused law firm. With a reputation for exceptional personal attention, unmatched professionalism, zealous advocacy, and a commitment to the utilization of innovative and interactive technologies, our firm has been able to serve over 160,000 clients for more than a decade.  We wish you the best in your pursuits and encourage you to engage our firm for legal representation. For more information, visit Sullolaw - Januvia Dangers

Wednesday, June 19, 2013

The Differences between a Januvia Class Action Lawsuit and a Januvia MDL

The FDA approved Januvia—a new class of sitagliptin drugs used in the treatment of Type 2 diabetes—in 2006. Only a few short years later the FDA had accumulated 88 reports of pancreatitis from those taking Januvia. Of those patients, three-fourths of them ended up in the hospital due to the severity of the pancreatitis. When Januvia was discontinued, over half saw an immediate improvement in their pancreatitis symptoms. Nearly a fourth of these patients developed pancreatitis less than a month after beginning Januvia.

Other studies have shown that Januvia may significantly increase the risk of pancreatitis, pancreatic cancer and thyroid cancer among users. A UCLA study put the numbers at six times the risk of developing pancreatitis and 2.9 times the risk of developing pancreatic cancer for Januvia users. Because of the number of Januvia patients who developed serious health issues after beginning the drug, Januvia lawsuits are increasing steadily.

Januvia lawyers are reaching out to those who have been harmed by Januvia which affects the GLP-1 metabolic pathway while keeping Type 2 diabetes under control. The active ingredient, sitaglipin, works by interfering with the GLP-1 metabolic pathway in the pancreatic duct. This interference may disrupt the cells in the pancreas which leads to pancreatitis and pancreatic cancer. One consolidated proceeding which involves multiple pancreatic cancer lawsuits is currently pending in the Los Angeles state court. Since millions of prescriptions have been written for Januvia, it is unknown just how many people will be adversely affected and how many Januvia lawsuits will be filed.

Some Januvia cases were filed in state court prior to being moved to federal court. Litigation can be managed much more efficiently when combined as resources can be shared. Depending on the number of Januvia lawsuits ultimately filed, a federal judicial panel could choose to centralize all Januvia cases under MDL procedures. Even if MDLs are formed, plaintiffs may choose to keep their Januvia lawsuits in state courts although it is expected that New Jersey will emerge as one of the more popular MDL venues as Merck & Co.’s headquarters are there. Another motion to consolidate more Januvia cases in the Southern District of California under a federal MDL is pending.

Although a fair number of lawsuits have been filed against Merck for the injuries sustained by patients taking Januvia, none have yet gone to trial. The first Januvia trial will be closely watched as it could set the tone for future Januvia lawsuit outcomes. A bellwether trial is scheduled for the summer however in light of the pending MDL’s it could be postponed. While no Januvia class action lawsuits are currently in the works, they may be organized down the road as more Januvia lawsuits are filed.


Januvia Class action lawsuits may not be a good option for patients who have been more severely injured since any settlement will be split evenly between all plaintiffs. MDLs or mass torts could be a better choice for those with serious Januvia damages in order to be fully compensated for medical expenses, pain and suffering and lost wages. Those who feel they may be entitled to compensation from Merck & Co for Januvia damages should consider contacting an experienced Januvia pancreatic cancer attorney.



Sullo & Sullo, LLP prides itself on being a client-focused law firm. With a reputation for exceptional personal attention, unmatched professionalism, zealous advocacy, and a commitment to the utilization of innovative and interactive technologies, our firm has been able to serve over 160,000 clients for more than a decade.  We wish you the best in your pursuits and encourage you to engage our firm for legal representation. For more information, visit Sullolaw - Januvia lawsuits
 

Monday, June 17, 2013

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.

Friday, June 14, 2013

Questions You May Have Regarding Januvia

Studies show the drug Januvia may be linked to pancreatitis and pancreatic cancer. Januvia is a drug which contains sitagliptin; this active ingredient will reduce the levels of blood sugar in those patients who suffer from Type 2 diabetes. Januvia inhibits certain enzymes in the body and reduces blood glucose levels. Some 45,000 Americans are diagnosed with pancreatic cancer each year, and only 3-4% of those will reach the five year survival rate. Pancreatic cancer is rarely discovered in the early stages as the typical symptoms can relate to many other health issues as well.

Some symptoms of pancreatic cancer include jaundice, weight loss or loss of appetite, a pain in the upper abdomen which can radiate to the back, depression and blood clots. When Januvia stimulates the pancreas to increase the amount of insulin produced the pancreas may become inflamed, significantly increasing the risks of pancreatitis and pancreatic cancer. Those patients who suffer from chronic pancreatitis are more likely to develop pancreatic cancer.  A UCLA research study places the risk of developing pancreatic cancer while taking Januvia at 2.9 times the normal risk.

Thyroid cancer may also be linked to Januvia. One study in which laboratory rats were injected with Januvia shoed the number of precancerous thyroid cells increased significantly. A 2011 journal article in Gastroenterology noted that while it is still under investigation Januvia was linked to thyroid cancer in humans as well. Although thyroid cancer is relatively rare, this type of cancer has a much better expected outcome than pancreatic cancer.

Those taking Januvia should be aware of the side effects related to thyroid cancer and be alert for any signs. A lump in the front part of the neck, hoarseness when speaking, throat or neck pain, trouble swallowing, an unexplained and persistent cough, enlarged lymph nodes, diarrhea or unexplained itching may all be symptoms of thyroid cancer. A UCLA study determined Januvia could potentially increase the risk of thyroid patients 148%.


The question has been raised as to whether Merck & Co. has exhibited a failure to warn although the company continues to maintain the safety of Januvia. FDA data shows hundreds of reports of acute and chronic pancreatitis attributed to Januvia in 2011 alone. Between 2006 and 2009, the FDA received 88 reports of pancreatitis from Januvia users, 66 of which resulted in hospitalizations. Nineteen of those patients developed pancreatitis within a month of beginning Januvia and over half saw their symptoms disappear once Januvia was discontinued.



Sullo & Sullo, LLP prides itself on being a client-focused law firm. With a reputation for exceptional personal attention, unmatched professionalism, zealous advocacy, and a commitment to the utilization of innovative and interactive technologies, our firm has been able to serve over 160,000 clients for more than a decade.  We wish you the best in your pursuits and encourage you to engage our firm for legal representation. For more information, visit Sullolaw -Januvia Lawsuits



Thursday, June 13, 2013

Are Users of the DPP-4 Inhibitor Januvia at a Higher Risk of Pancreatitis and Pancreatic Cancer?


Pancreatitis Symptoms
Pancreatitis occurs when the pancreas—located behind the stomach in the upper part of the abdomen—becomes inflamed. The pancreas is a gland which produces digestive juices which break down proteins and fats in foods eaten so the nutrients can be properly absorbed. The bicarbonate in those digestive juices neutralizes stomach acids. The pancreas also produces the digestive hormones, insulin and glucagon which control the body’s blood sugar levels and can play a key role in diabetes when not functioning correctly. When the pancreas becomes inflamed, the digestive juices may end up trapped, leading them to actually begin digesting the pancreas itself. The pancreas loses its ability to carry out normal functions when it is inflamed, and in certain cases pancreatitis can be so severe that it is life-threatening.

When Pancreatitis Leads to Pancreatic Cancer
Acute or chronic pancreatitis may eventually lead to pancreatic cancer. Symptoms of pancreatic cancer can often be elusive therefore many of those diagnosed with pancreatic cancer do not receive the diagnosis until the disease is fairly advanced. According to the American Cancer Society, only about 23% of patients with exocrine cancer of the pancreas will remain alive a year after the initial diagnosis.  Pain in the upper or middle abdomen and back, unexplained weight loss, depression, fatigue and loss of appetite are all symptoms of pancreatic cancer, yet can also be symptoms of many other illnesses as well. While diabetics do appear to suffer a higher risk of developing pancreatitis, research on Type 2 diabetic drugs such as the DPP-4 Inhibitor Januvia show a higher risk among patients taking the active ingredient in Januvia—sitagliptin. 

The DPP-4 Inhibitor Januvia and Adverse FDA Reports
Januvia, manufactured by Merck, blocks DPP-4 (dipeptidyl peptidase-4), allowing the body to control glucose levels in a more efficient manner. Any excess sugar produced by the liver can also be handled through the use of Januvia. Januvia gained FDA approval in 2006, yet only a few short years later adverse reports regarding the drug and a higher incidence of pancreatitis began coming in. From 2006 to 2009, 88 cases of pancreatitis—sixty-six of which required hospitalization—were reported to the FDA. Of those, over half of the cases resolved when Januvia was discontinued.  Nineteen of those patients developed pancreatitis less than thirty days after beginning Januvia. Januvia has also—rarely—been linked to severe allergic reactions and the development of a skin disorder known as Stevens-Johnson Syndrome. Januvia thyroid cancer is also a potential risk as at least one study showed that laboratory rats developed thyroid cancer when given sitagliptin.

Significant Risks of Januvia Require Experienced Legal Representation
A study done at UCLA and reported in the journal Gastroenterology revealed that those taking Januvia had approximately six time the risk of developing pancreatitis and 2.9 times the risk of pancreatic cancer. These risks are significant and those who have developed a serious illness from a drug they believed to be safe are advised to contact qualified Januvia Pancreatic Cancer Attorneys. Failure to warn consumers of the potential risks associated with Januviaas well as negligence on the part of Merck may have led to your serious health issues.



Sullo & Sullo, LLP prides itself on being a client-focused law firm. With a reputation for exceptional personal attention, unmatched professionalism, zealous advocacy, and a commitment to the utilization of innovative and interactive technologies, our firm has been able to serve over 160,000 clients for more than a decade.  We wish you the best in your pursuits and encourage you to engage our firm for legal representation. For more information, visit Sullolaw - Januvia Dangers