Januvia side effects include pancreatic cancer, pancreatitis, and even death. We are working with experienced Januvia lawyers across the United States, who can file a claim and/or Januvia lawsuit on your behalf and charge no fee until you receive an award or settlement. Contact us for a free consultation toll free at 1-800-992-6878 or visit us online and fill out a contact form.
Januvia Side Effects
This diabetes drug has been linked to serious side effects such as pancreatic cancer, pancreatitis, and in some cases, even death. The FDA stated that there were 88 cases of pancreatitis reported in Januvia patients between October 2006 and February of 2009. The FDA is working with the drug’s manufacturer, Merck & Co., to produce a new warning label for the medicine.
The FDA has advised healthcare professionals to carefully monitor patients for development of pancreatitis during treatment. Pancreatitis is linked to morbidity and mortality, so early recognition is crucial. It is difficult to establish pancreatitis as a definite side effect of the drug because it is used mainly in type 2 diabetes patients, a class of patients who are already at an increased risk of pancreatitis.
Symptoms of pancreatitis to be aware of are:
- Pain, usually centered in the upper middle or upper left abdomen
- Swollen abdomen that is sensitive to the touch
If you begin noticing the presence of these side effects after beginning treatment or adjusting your Januvia dosage, please contact your healthcare provider.
Januvia and Pancreatic Cancer
Pancreatitis is inflammation of the pancreas, the organ responsible for secreting digestive enzymes. It is also involved in regulating blood sugar because it releases insulin. Pancreatitis can occur when the enzymes become active prematurely, while still inside the pancreas, this condition can occur acutely or chronically, which can cause damages to the organ over time, leading to pancreatic cancer.
You should speak to you doctor if you are experiencing any of the signs of pancreatic cancer, including:
- Upper abdominal pain (swelling or tenderness), possibly radiating to the back
- Loss of appetite, weight loss
- Blood clots
- Increased heart rate
Januvia and Thyroid Cancer
Research has found that diabetes medications like Januvia can cause an increase in precancerous thyroid cells. The thyroid gland secretes hormones responsible for regulating heart rate, blood pressure, body temperature, and weight. Although most cases of thyroid cancer can be cured with proper treatment, the cancer may come back. Signs of thyroid cancer include:
- A lump on the skin of your neck
- Changes in voice (i.e. voice becoming more hoarse)
- Difficulty swallowing
- Neck and throat pain
- Swollen lymph nodes
Due to the number of reports about harmful Januvia side effects, different entities have been taking action. The FDA issued a public safety alert in September of 2009, warning the public of the drug’s side effects and the potential dangers that could be associated with its use for some at-risk patients.
Dangerous drug lawyers across the country have responded to calls for help from clients who had suffered acute pancreatitis as a result of using the medication. These attorneys are prepared to represent those victims who have experienced this drug’s severe side effects, and argue on claims of product liability, negligence, and a failure to warn. Several lawsuits have already been filed against Merck & Co., and trends indicate that claims arising from use of this medication will continue.
Even though these cases against Merck have not yet been consolidated through multi-district litigation (MDL) and individuals are still filing suit in their own capacity; if there are enough single lawsuits, then the Court will form an MDL. An MDL lawsuit requires many plaintiffs from all across the U.S., and these plaintiffs stand to receive greater amounts of compensation because Merck will feel a much heavier burden than would be felt in the case of simply individual lawsuits.
Januvia Medical Studies
In September 2009, the FDA indicated that there were 88 cases of pancreatitis reported among diabetic patients using the drug, including at least two cases of hemorrhagic pancreatitis or necrotizing pancreatitis. It appears likely that there is a connection between Januvia and pancreatitis as many of the reported cases developed within 30 days of starting treatment with the drug, and 53% of cases resolving once medication was stopped. Over two-thirds of reported cases resulted in hospitalization, and four cases required treatment in a hospital intensive care unit.
In 2011, researchers again reported on the link between developing pancreatitis and pancreatic cancer in patients using this diabetes medicine. Studies examined those adverse events that had been reported to the FDA between 2004 and 2009. Researchers think that Januvia may inadvertently trigger growth in pancreatic gland ducts. They also emphasize that further studies are needed to assess these risks.
A more recent 2012 study found that using Januvia to treat Type 2 Diabetes increases the risk of pancreatic cancer by 2.7 times. These findings were the result of an investigation into the effects of GLP-1-based medications. These drugs are designed to stimulate insulin secretion from the pancreas so that the body’s cells can better absorb glucose from the blood stream. Unfortunately, there are now signs indicating that a causal relationship may exist between Januvia and pancreatic cancer.
About Januvia’s Manufacturer
This drug is manufactured by Merck & Co., Inc. The drug was first marketed and sold back in 2006. Since that time, it is estimated that more than 18 million prescriptions have been filled for this medication for purposes of treating diabetes. During the period of 2006 to 2011, product sales reached $9.8 million. Worldwide sales for the year 2011 were $3.3 billion. Sales for the first quarter of 2012 reached $919 million. Sales the following quarter jumped 36% from the same quarter a year ago, reaching $1.058 billion. Januvia has become a staple for Merck, and one of the company’s biggest growth engines.
At the same time sales for this drug were increasing, Merck neglected to conduct safety studies. In a February 2012 warning letter, the FDA criticized Merck & Co. for failing to conduct a promised animal study of drug-related pancreatitis risk. The FDA mentioned in its letter that the company “failed to comply with the approved timetable and…failed to show good cause for not conducting the additional testing required to further assess whether a signal of pancreatitis represents a public health risk.”
Merck tried to submit a 12-month independent study from a third party to the FDA to satisfy the post-market requirement, but the agency found this information to be insufficient. Reports indicate that Merck’s failure to conduct the required studies may lead to a $250,000 fine and possible additional penalties in the event of continuing further violations. The FDA also marks this particular diabetes drug as misbranded due to Merck’s continual violation of deadlines by which studies were to be conducted.
This is not the only instance where Merck tried to avoid conducting studies. In November 2011, the FDA sent a “Failure to Respond” letter to Merck about the company’s failure to provide data, to which Merck replied by including a description of the protocol for the ongoing independent study. Since then, Merck had not provided a final protocol submission for a new study that would fulfill the FDA’s requirements.
Contact the Law Offices of d'Oliveira & Associates
If you or a loved one has suffered severe complications due to Januvia use, you may want to speak with an injury attorney regarding a potential claim. A personal injury lawyer familiar with new developments in the investigation of this drug may be able to help you make important personal and legal decisions.
Feel free to call d'Oliveira & Associates at 1-800-992-6878 or fill out an online contact form for your free legal consultation.