What is Januvia?
Januvia (sitagliptin) was first approved in October 2006 by the U.S. Food and Drug Administration (FDA). The drug was created in an effort to help patients previously diagnosed with type 2 diabetes gain control of their blood glucose levels. The first of its kind, the oral medication was classified as a DPP-4 inhibitor that helped to increase the body’s production of insulin. Unfortunately, studies have shown that the drug may directly raise the patient’s risk of developing pancreatitis and pancreatic cancer following an initial dose and subsequent dosage increases. Patients experiencing these side effects have filed Januvia lawsuits seeking damages for their suffering.
History of Januvia
Januvia was created by Merck & Co., Inc. to help the body produce insulin by affecting the incretin system and targeting pancreatic cells, yet it may also restrict the body from fighting against various types of cancer; research has shown that the DDP-4 inhibitors helps stop cancerous cells from spreading throughout the body. As a result, many physicians and medical experts agree that the drug has the potential to cause adverse conditions including thyroid and pancreatic cancers and pancreatitis.
Plaintiffs File Januvia Lawsuits against Merck
Patients who had been taking the medication and suffered serious side effects allege that, although the FDA required Merck to complete specific studies regarding the safety of the drug, the manufacturer delayed the process, thus drastically reducing the possibility of finding side effects or risks of serious health conditions before the drug was marketed for sale to the public. Plaintiffs in Januvia lawsuits allege that, had Merck acted according to the FDA’s direction, these health risks would have been apparent much sooner, and patients would have been informed of the effects and possibility of developing cancers before the issue became more serious.
Physicians maintain that some side effects are relatively common from taking the medication including:
- Stomach pain
- Sinus complications
- Sore throat
However, many plaintiffs in Januvia lawsuits allege that they suffered from even more adverse effects including:
- Severe skin reaction as noted by painful sensation on the skin, sore throat, rashes, burning eyes, facial swelling and fever
- Gaining a rapid amount of weight quickly
- Shortness of breath
- Swelling of face or body
- Difficulty urinating or not urinating at all
Patients who were eventually diagnosed with pancreatitis did not initially know that they had the disease when they first started noticing symptoms; rather, many plaintiffs in Januvia lawsuits allege that they were not fully aware that these side effects were the start of the condition. Most notably, patients claimed that they suffered from nausea, vomiting, decreased or loss of interest in food, irregular or increased heart rate and a severe pain that traveled from the stomach to the back.
Research Concludes Januvia May Cause Cancer
Researchers conducted studies in both May 2009 and again in 2011 to examine the possible connection between Januvia, pancreatitis and pancreatic cancer; the results confirmed that although the drug has been successful in helping people with type 2 diabetes manage their blood glucose levels, there was indeed an increased risk of developing both health conditions by taking the medication. The latter study reported participants taking the drug had a six-fold probability of suffering from pancreatitis further down the road, and those taking the drug had a two-fold possibility of developing pancreatic cancer in the future.
Physicians are warning consumers to conduct research before using the drug, particularly because it took over three years for these results to become apparent; there is no telling how long it may be before the medication is linked to other serious health conditions.
FDA Requests a Revision to Label
The FDA has acknowledged that they are currently investigating Januvia as the result of its possible link to serious health conditions. In fact, the FDA has reported evidence of inflammation and various levels of pre-cancerous cell changes in sample tissues they obtained from patients who were reportedly taking the medication.
However, in September 2009, the FDA requested that Merck revise the label on the medication to acknowledge the new and potential hazardous side effects associated with the drug. The FDA maintained that consumers must be warned prior to the initial dose and be aware of the current reports of the potential to develop various forms of acute pancreatitis. Additionally, the FDA asked the manufacturer to ensure that physicians and healthcare professionals knew to monitor their patients after prescribing the medication or after the dosage was increased in order to watch for the first signs of pancreatitis. Merck was also asked to instruct doctors to cease prescribing the drug if their patients started to report serious complications.
In the letter issued to Merck, the FDA maintained that Merck should acknowledge that the drug only be used with thorough monitoring methods, particularly in those who are at a predisposed risk of developing pancreatic cancer and pancreatitis and especially in patients who have a medical history of the diseases. Unfortunately, even though the FDA requested Merck make the necessary changes to the label and conduct further research in 2009, the organization still needed to chastise the manufacturer for failing to follow through by 2012.
Have you or a loved one been diagnosed with type 2 diabetes and been prescribed Januvia to help monitor your blood glucose levels? If you are currently taking the medication and are experiencing serious side effects or have been diagnosed with pancreatic cancer or thyroid cancer, contact the American Injury Attorney Group to learn more about your potential claims and about filing a Januvia lawsuits. We will review your case, free of charge, and help to determine if you can join the many others that have filed Januvia lawsuits to seek compensation against Merck.