Incretin Mimetic Drugs
The Problem: Allegations have been made of possible increased risk of pancreatitis, inflammation of the pancreas, and pre-cancerous findings of the pancreas from this specific drug class.
The Response: The FDA continues to update warnings of possible complications from the drugs through 2015.
What Can We Do to Help: Our experienced attorneys can review your medical records and advise you if filing a case is in your best interest.
The attorneys at Gallon, Takacs, Boissoneault & Schaffer are currently investigating potential claims on behalf of patients who have suffered any complications while taking an Incretin Mimetic Drug to treat Type II Diabetes. If you or someone you know has been diagnosed with severe pancreatitis, pancreatic cancer, or thyroid cancer, you may be able to file a claim against the manufacturing company for compensation of medical bills, pain and suffering and other damages. Find out with a free case evaluation.
The FDA started to investigate unpublished reports by a group of academic researchers of possible increased risk of pancreatitis, inflammation of the pancreas, and pre-cancerous findings of the pancreas from this specific drug class.
Incretin mimetic drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. These drugs help regulate glucose metabolism and insulin secretion. They are used along with diet and exercise to lower blood sugar in adults with Type II Diabetes.
The Diabetes drugs FDA is investigating within this Incretin Class includes:
- Byetta Injections
- Victoza Injections
Cases are being filed alleging:
- Thyroid Cancer
- Pancreatic Cancer
Byetta, a popular injectable drug, was approved on April 28, 2005 and is manufactured by Amylin Pharmaceuticals, Inc. Amylin was founded in 1987 and engaged in the discovery, development and commercialization of drug candidates for the treatment of diabetes, obesity and other diseases. In July 2012, Bristol-Myers Squibb acquired Amylin Pharmaceuticals for $5.3 billion and in December 2013, Amylin was acquired by AstraZeneca for $3.5 billion for a portion of the profits from Amylin’s drugs.
On October 17, 2007 the FDA received approximately 30 reports of acute pancreatitis in patients taking Byetta while 27 of the 30 patients had at least one other risk factor for acute pancreatitis such as gallstones, severe hypertriglyceridemia and alcohol use. Six of these patients’ pancreatitis symptoms began or worsened soon after dose was increased from 5 mcg twice daily to 10 mcg twice daily and 5 patients developed serious complications, including but not limited to, dehydration, renal failure, suspected blockage of the intestines, phlegmon (acute supportive inflammation affecting the subcutaneous connective tissue), or ascites (fluid in the abdomen cavity). At this time, FDA asked the manufacturing company, Amylin Pharmaceuticals, Inc., to include information about acute pancreatitis suspected in some cases and they agreed.
On August 18, 2008 FDA releases an update stating that the agency had received approximately 6 additional cases of pancreatitis, including necrotizing pancreatitis along with 2 deaths being reported.
Additionally, on October 30, 2009 FDA approved a risk evaluation and mitigation safety strategy (REMS) for Byetta. The REMS was part of an approval for a new indication for Byetta to be used as an adjunct to diet and exercise to improve glycemic control in adults with Type II Diabetes. Previously, this drug was only approved for use in combination with other anti-diabetic drugs. Byetta is now approved for use as a stand-alone medication along with diet and exercise. Orville G. Kolterman, MD, senior vice president of research and development at Amylin Pharmaceuticals said “The expanded indication gives physicians the option to prescribed Byetta as a first-line treatment, increasing the number of patients who may benefit from the medication and providing an opportunity to treat patients with Byetta earlier in the disease.”
Januvia was approved on October 17, 2006 and is manufactured by Merck & Co. Approval for Januvia was based clinical trials proving this drug to be effective in controlling blood sugar levels. However, there were also reports of serious side effects, including acute pancreatitis, and pancreatic cancer.
Between 2006 and 2009, there were approximately 100 cases of acute pancreatitis, including necrotizing pancreatitis. In 2009, the FDA issued a safety alert which linked Januvia to acute pancreatitis However, there were no studies conducted in people who have a history of pancreatitis, and the agency warned it is still unknown whether these people are an increased risk.
Additionally, in 2011, the FDA received almost 200 reports of acute and/or chronic pancreatitis, some which were fatal, linked to the use of Januvia bringing a label update in March 2012.
Victoza was FDA approved on January 25, 2010 and is manufactured by Novo Nordisk of Bagsvaerd, Denmark. The FDA approval was based on five double-blind, randomized, controlled clinical trials, one of 52 weeks duration and four of 26 weeks duration in approximately 4,000 patients. The active ingredient in Victoza, liraglutide, functions in the same manner as a glucagon-like peptide-1 (GLP-1), which helps to promote glucose metabolization and insulin secretion in the pancreas. Since its approval, Victoza has become one of the most popular diabetes drugs on the market, racking sales up to nearly $670 million in 2011.
In May 2011, FDA sent out a warning to add to the “warning and Precautions” sections regarding the drug association use with renal impairment. Additionally, in June 2011, the FDA issued a warning that Victoza had been linked to thyroid cancer. The FDA’s Adverse Event Reporting System received 25 claims of thyroid cancer and Victoza from February 2010 to September 2011. In addition, there were at least 200 cases reported of acute pancreatitis and 28 cases of pancreatic cancer.
One of the first studies was in February 2013 which was led by Dr. Sonal Singh of Johns Hopkins University School of Medicine and Public Health found that the risk of pancreatitis is twice as likely to be hospitalized with pancreatitis within 60 days of first taking the drugs as those who had taken a different medication.
In March 2013 the FDA started to investigate unpublished reports by a group of academic researchers of possible increased risk of pancreatitis, inflammation of the pancreas, and pre-cancerous findings of the pancreas from this specific drug class. These findings were based upon examination of a small numbers of pancreatic tissue specimens taken from patients after they died from unspecified causes.
Additionally, on August 28, 2015 FDA published a drug and safety communication warning that the type 2 diabetes medicines may cause joint pain that can be severe and disabling. The FDA further added an update to the warning and precautions section of all medicines in this drug class.
If you or someone you know has taken an Incretin Memetic Drug to treat Type II Diabetes and have had any of the alleged injuries, you may be entitled to compensation. The Incretin Mimetic attorneys at Gallon, Takacs, Boissoneault & Schaffer are dedicated to ensuring pharmaceutical companies are held responsible for the dangerous side effects of their products. Call our Incretin Mimetic Attorneys today or fill out the free case evaluation. We want to help you.