Diabetes Drug - Byetta
FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes
[3-14-2013] The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular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.
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.
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 communicate its final conclusions and recommendations when its review is complete or when the Agency has additional information to report.
FDA previously warned the public about postmarketing reports of acute pancreatitis, including fatal and serious nonfatal cases, associated with the use of the incretin mimetic drugs exenatide and sitagliptin. A recently published study that examined insurance records also found the use of exenatide or sitagliptin could double the risk of developing acute pancreatitis.1 The Warnings and Precautions section of the drug labels and the 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 findings of the pancreas with incretin mimetics. Further, 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.
FDA is continuing to evaluate all available data to further understand this potential safety issue. In addition, FDA will participate in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Cancer Institute’s (NCI) Workshop on Pancreatitis-Diabetes-Pancreatic Cancer in June 2013 to gather and share additional information.
FDA urges both patients and health care professionals to report adverse events involving incretin mimetics to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.
1. Singh S, Chang HY, Richards TM, Weiner JP, Clark JM, Segal JB. Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med 2013 Feb 25:1-6. doi: 10.1001/jamainternmed.2013.2720. [Epub ahead of print].
Source : FDA (March 2013)
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Four More Deaths Associated With Byetta
Lilly and Amylin Pharmaceuticals are saying there have been four deaths among patients with pancreatitis who took their Byetta diabetes drug, in addition to the two deaths reported last week by the FDA. Amylin says the four cases were not captured by the FDA, which received six reports of patients who developed hemorrhagic or necrotizing pancreatitis that required hospitalization. Two of those died. The additional four cases reported today did not involve patients with the necrotizing form of the disease, which affects 15 percent to 20 percent of patients with inflammation of the pancreas.
“It appears the FDA focused on necrotizing and hemorrhagic pancreatitis, whereas these other four cases only had pancreatitis in their history,” Orville Kolterman, Amylin’s senior vice president of research and development, tells Reuters.
In the necrotizing form of pancreatitis, enzymes digest the pancreas, which can lead to a hemorrhage. However, Kolterman says the deaths were not considered related to the pancreatitis. Even so, he said the company was reporting them “in the interests of transparency.”
The prescribing information for Byetta, which has been taken by an estimated 1 million patients, was updated to include the risk of pancreatitis last October. The FDA cited 30 reports of pancreatitis in Byetta patients and said the drug was suspected in some cases. One of the four deaths reported on Tuesday was known at that time, Kolterman says.
News of the deaths that were reported by the FDA on Aug. 18 sent Amylin’s shares down 13 percent, and investors questioned the company’s failure to issue a news release or hold a conference call to discuss it. Now, Amylin says it is providing all info possible to ensure patients are not confused by what they read and that future cases of pancreatitis are not necessarily interpreted as being related to treatment with Byetta.
Kolterman adds they don’t expect any link to Byetta LAR, a once-weekly updated formulation that Wall Street is excited about. He says no cases of pancreatititis have been seen in patients being tested with the new version.
SOURCE Pharmalot (Aug 26th 2008)
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Byetta (exenatide) - Renal FailureAudience: Endocrine and nephrology healthcare professionals
FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Labeling changes include:
- Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.
- Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
- Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.
- Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.
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