An estimated 25 million people have diabetes in the United States. Treatments for diabetes cost Americans around $245 billion each year, and there are a number of treatment options used by diabetics to stabilize their insulin and blood-sugar levels.
Januvia is one medication commonly used in the treatment of diabetes. Januvia is manufactured by Merck & Co. and is an oral antihyperglycemic that was prescribed to more than 2 million patients in 2011. Januvia is prescribed either alone or in conjunction with another medication called Byetta.
While some estimates indicate that sales of Januvia may reach as much as $6 billion a year due to the aging of the population and the increase in diabetes cases, there are also increasing concerns about whether Januvia is a safe medication.
Januvia has been linked to pancreatic cancer, and the U.S. Food and Drug Administration (FDA) has warned of a potential increase in the risk of acute pancreatitis in patients prescribed Januvia or other versions of the medication.
If you or a loved one took Januvia and experienced complications as a result, you may have a legal claim for damages. An experienced defective drug lawyer at Roberts & Roberts can help you pursue your case and recover the compensation you deserve.
The Dangers of Januvia
Januvia is a brand name for a medication called sitagliptin, which is part of a class of medications called DPP-4 inhibitors. DPP-4 in the body has the job of breaking down incretin. When Januvia blocks DPP-4, incretin remains in the blood longer. Incretin stimulates the pancreas to remove excess sugar from the body and produce insulin. The extra insulin and the extra effort to remove sugar from the body help stabilize blood sugar in diabetic patients, providing an effective method of treating diabetes.
Sitagliptin was approved by the FDA in October 2006. By 2007, the FDA had also approved a related drug, which was a combination of sitagliptin and metformin that was marketed as Janumet.
Problems became apparent shortly after the medication was released. From October 2006 to February 2009, there were more than 88 post-marketing cases of pancreatitis reported to the FDA. Two of those cases included hemorrhagic or necrotizing pancreatitis. This high number of complaints prompted the FDA to issue a safety alert in September 2009, notifying health-care professionals and patients of the risks of acute pancreatitis linked to Januvia.
A subsequent study conducted by researchers at the University of California, Los Angeles, revealed that the risk of developing pancreatitis increased sixfold in patients taking Januvia as compared with other type-2 diabetes treatments.
Pancreatitis, or severe inflammation of the pancreas, is fatal in 10-30 percent of patients who develop the condition. When a patient develops pancreatitis, the pancreas becomes inflamed and the digestive enzymes of the body can begin to attack the pancreas. Infections, cyst formation, tissue damage and internal bleeding are common in patients with pancreatitis. Pancreatitis acts quickly to damage the body, including the kidneys, lungs and heart.
Pancreatitis is not the only potential problem with the medications. Studies have also suggested a link between Januvia and cancer, including pancreatic and thyroid cancer.
Januvia and Cancer
According to the U.S. National Library of Medicine, DPP-4 is a membrane-bound enzyme that has a role in cancer growth. This means that patients who take Januvia may have a greater risk of developing cancer. Numerous studies have identified a potential link between Januvia and cancers in recent years, including:
- A 2011 study published in Gastroenterology. This study was conducted by researchers at UCLA and revealed that patients taking Januvia had as much as three times the risk of developing pancreatic cancer.
- The same UCLA study revealed that patients taking Januvia had as much as five times the risk of developing thyroid cancer.
- Three studies published in 2013 indicated that incretin therapies such as Januvia were potentially linked to increased pancreatic risks including pancreatic cancer.
- A study published in Diabetes indicated that patients treated with incretin therapy experienced cell damage and experienced as much as a 40 percent increase in pancreatic cells. This cell proliferation and damage has the potential to evolve into cancer.
Approximately 80 percent of pancreatic cancer diagnoses are made after the cancer has spread outside of the pancreas to other areas of the body. The cancer is generally metastatic, or stage IV, and a cure is not possible. As a result, as much as 95 percent of patients diagnosed with pancreatic cancer die within five years.
Taking Legal Action
A report in the British Medical Journal (BMJ) revealed that there had been no warning of the link between sitagliptin (Januvia) and pancreatic disease. The report indicated that both the drug manufacturer and the FDA had failed to provide proper information to patients about the risks of Januvia. BMJ made this determination after using Freedom of Information Act requests to locate thousands of pages of regulatory documents.
Some patients may have experienced grave harm as a result of the link between Januvia and pancreatic problems. These patients likely were not fully informed of the dangers and risks they faced when taking the medications, meaning they may not have been able to give informed consent.
Patients who have been harmed by Januvia may have the legal right to pursue a claim for compensation to cover their losses. This may include payment of medical bills, compensation for lost wages and compensation for damage caused by pain and suffering and emotional distress. If the medications led to a fatal condition and the victim has died, then close family members may be able to pursue a wrongful death claim.
An experienced defective drug lawyer at Roberts & Roberts can help with your claim. Contact us today at 903-597-6000 or use our online form to schedule a free consultation and learn how we can help you to take action.