Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication – Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas

May 9, 2013

May 09, 2013 – We have just stumbled upon a recent press release to the public by the American Food and Drug Administration (FDA) on a looming drug safety problem of incretin mimetic drugs related to the pancreas. Find here the unedited press releaase in full:

[Posted 03/14/2013]

AUDIENCE: Gastroenterology, Endocrinology, Oncology, Patient

ISSUE: FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.

BACKGROUND: Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

RECOMMENDATIONS: FDA has not reached any new conclusions about safety risks with incretin mimetic drugs. This early communication is intended only to inform the public and health care professionals that the Agency intends to obtain and evaluate this new information. FDA will participate in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Cancer Instituteā€™s (NCI) Workshop on Pancreatitis-Diabetes-Pancreatic Cancer in June 2013 to gather and share additional information. FDA will communicate its final conclusions and recommendations when its review is complete or when the Agency has additional information to report.

The Warnings and Precautions section of drug labels and patient Medication Guides for incretin mimetics contain warnings about the risk of acute pancreatitis. FDA has not previously communicated about the potential risk of pre-cancerous findingsĀ  of the pancreas with incretin mimetics. FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer.

At this time, patients should continue to take their medicine as directed until they talk to their health care professional, and health care professionals should continue to follow the prescribing recommendations in the drug labels.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: http://www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


Bristol-Myers gets approval for its diabetes drug Saxagliptin [Onglyza] in the European Union (EU)

October 14, 2009

October 14, 2009 – On October 5, 2009, drug maker Bristol-Myers Squibb Co. announced that its new diabetes drug, Saxagliptin [Onglyza], has been approved for sale in the European Union’s (EU) 27 countries.

Saxagliptin [Onglyza] is the first diabetes drug to be launched in Europe by a partnership of New York-based Bristol-Myers and British drugmaker AstraZeneca PLC to develop drugs for type 2 diabetes. It was approved for use with three other standard diabetes drugs, based on six late-stage studies including more than 4,100 patients. Saxagliptin [Onglyza] and Merck & Co.’s Sitagliptin [Januvia] both are in a newer class of diabetes medicines called DPP-4 inhibitors. They work by increasing insulin production and lowering the production of glucose

Saxagliptin [Onglyza] will compete with Merck & Co.’s blockbuster diabetes drug Sitagliptin [Januvia] both in the EU and in the United States, where the Bristol Myers drug was approved on July 31, 2009. Whitehouse Station, N.J.-based Merck’s Sitagliptin [Januvia] and a related drug called Janumet, which includes metformin, constitute Merck’s fastest-growing product line, third in overall sales with a total of $1.75 billion in revenue last year. Saxagliptin [Onglyza] is to be launched in the European Union by year’s end; it’s already on sale in the U.S. Analysts have forecast that Saxagliptin [Onglyza] sales could hit as high as $1 billion a year, given the alarming increase in the number of people in developed countries with diabetes. The U.S. market for diabetes medicines alone already exceeds $5 billion annually.

Meanwhile, Bristol and AstraZeneca are in late-stage testing of another potential diabetes drug, dapagliflozin, that works by helping the kidneys eliminate excess glucose. Saxagliptin [Onglyza] was approved to be used with metformin or another drug from one of two different classes that are often prescribed, along with diet and exercise, when patients are first diagnosed with type 2 diabetes. People with the disorder, most often caused by obesity and inadequate exercise, do not use the insulin made by their body efficiently and may eventually need injected insulin as well as pills to control the disease.

Also Monday, Bristol and AstraZeneca released results of a new study showing that Saxagliptin [Onglyza] with metformin works roughly the same as Sitagliptin [Januvia] with metformin, reducing a key measure of long-term blood sugar level by 0.52 percent, compared with a 0.62 percent reduction for the patients in the Januvia group.

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