Lawyer for Dangerous Incretin Mimetics
Diabetes Drugs Linked to Increased Pancreatic Risk
Januvia and diabetes drugs are used to treat Type-2 diabetes all throughout the United States, but a new study has discovered that these diabetes medications may cause serious damage to a patient's pancreas and increase the patient's risk of cancer. According to a small study that was led by professors at the University of California, Los Angeles, there is evidence that taking these drugs can increase pre-cancerous changes.
Now, the U.S. Food and Drug Administration is researching the situation to find more information after they were alerted of the discoveries. The FDA says that the findings of the study are currently unpublished but the government agency hopes to continue research. The FDA admits that they have already received reports of patients with Type-2 diabetes that have developed pancreatic cancer and believe that it may be the direct result of the incretin mimetics in their medication. Some of the drugs known to carry this compound are Byetta, Januvia, and Victoza.
Information About Incretin Mimetics
Investigations are focusing on incretin mimetics, which is an injectable diabetes medication. Incretin mimetics work by mimicking the natural hormone incretin, which tells the body to release insulin to help lower blood sugar. It accomplishes this by telling the pancreas to release insulin when the blood sugar is spiking; by preventing the pancreas from releasing too much glucagon, which causes the liver to release stored sugar; and by slowing the rate of the patient's stomach emptying. Incretin mimetics is an alternative to insulin, which was the only acceptable treatment for diabetes for decades. Currently, it is only approved for the treatment of type 2 diabetes.
Drugs in the incretin mimetic class include the following:
- Exenatide (Byetta, Bydureon)
- Liraglutide (Victoza)
- Sitagliptin (Januvia, Janumet, Janumet XR, Juvisync)
- Saxagliptin (Onglyza, Kombiglyze XR)
- Alogliptin (Nesina, Kazano, Oseni)
- Linagliptin (Tradjenta, Jentadueto)
Previous FDA Warnings Regarding Diabetes Treatment
In August 2008, the FDA announced that they had received six reports of individuals who had suffered from hemorrhagic or necrotizing pancreatitis from individuals who had been taking Byetta. All six patients required hospitalization; two died and four recovered. Earlier, in October 2007, the FDA had stated that they had received thirty reports of patients who were taking Byetta and had suffered acute pancreatitis. This resulted in Amylin Pharmaceuticals, Inc. including acute pancreatitis in the precautions section.
In September 2009, another incretin mimetic drug came under fire when the FDA released a safety warning about Januvia and Janumet. In the safety information release, the FDA warned that they had received 88 post-marketing cases of patients suffering from acute pancreatitis after taking this form of diabetic treatment. The FDA encouraged healthcare professionals to inform patients of these risks and to monitor all patients taking the drug.
Study: Looking into the Effect on the Pancreas
After receiving a shot of incretin mimetics in the form of a Type-2 diabetes drug, the pancreas should start producing the insulin. Researchers examined 20 diabetics and specifically looked at the effect that the drugs they were taking had on their pancreases. As a result, they noticed that there was a 40% increase in the amount of pancreatic cells and in cell damage in any patients that were treated with an incretin therapy. 12 of the diabetics never received an incretin mimetics and did not suffer the same risk of cell development and cell damage. Those who did suffer pancreatic cell damage were either on the drug Januvia or the medication known as Byetta.
Following the release of the study, Public Citizen, a public advocacy group, had the following to say:
"These findings are in accord with the rapidly increasing number of reports to the [FDA] of pancreatic cancer in patients using these drugs compared with diabetics using other drugs."
Researchers argue incretin therapy can lead to marked cell proliferation and damage. Eventually, this can develop into pancreatic cancer. Drug manufacturers deny the findings of the study, claiming that the connection between the medications and cancer is not direct. The FDA still has not concluded that the drug actually causes cancer. The fear is that the taking of any type of incretin mimetics may result in pancreatitis and pancreatic cell growth.
FDA Investigates Type 2 Diabetes Drug
The FDA released a statement on March 14, 2013 announcing a new investigation into the possible increased risk of pancreatic injury caused by certain type 2 diabetes medications. The FDA is evaluating findings that may suggest a connection between the use of incretin mimetics and damage to the pancreas. The study being focused on in this investigation has yet to be published and claims to have revealed an increased risk of acute pancreatitis and possibly even pancreatic duct metaplasia, which is the term used for pre-cancerous cellular changes in the pancreas that may lead to the development of pancreatic cancer. The investigation is inconclusive as to the credibility of this study but the FDA announced the launch in order to inform users of the medication on the current status of their drug.
Certain incretin mimetics have been the subject of scrutiny by the FDA in the past, namely exenatide and sitagliptin. Exenatide received attention after eight cases of acute pancreatitis had been reported by users of the medication. All of the injured required hospitalization and two cases ended in fatality. Sitagliptin, also known as Januvia and Janumet, was linked to 88 cases of acute pancreatitis. While almost half of those cases were resolved after the medication was discontinued, the report was enough to warrant warning as to the safety of the drug.
The FDA is stressing the fact that this investigation is just beginning and results are far from conclusion. Patients are not yet advised to discontinue their use of incretin mimetics and doctors are still permitted to prescribe the medications. The medications currently include the possible risk of pancreatitis in the warnings and instruction labels included on the prescription, the FDA is investigating just how possible or imminent that risk is.
Get the Involvement of a Drug Injury Attorney
If you have reason to believe that you or a loved one has suffered pancreatic damage caused by incretin therapy or any type of diabetes drug, you should not hesitate to get the involvement of a legal professional. The drug injury lawyers at Arnold & Itkin LLP have recovered billions of dollars in verdicts and settlements, including a record-setting $76.6 million verdict against Johnson & Johnson for their harmful drug Risperdal. If you are looking for someone who can stand up for your rights and fight for you, you've come to the right place.
All you need to do is schedule an initial case consultation by calling today at (888) 493-1629.