Safety advice on particular drugs or classes of drugs
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| The United States: Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas |
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The Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct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.
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 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 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 findings 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 healthcare professional, and healthcare professionals should continue to follow the prescribing recommendations in the drug labels.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm343805.htm
In Hong Kong, there are 15 registered pharmaceutical products belong to the class of incretin mimetic drugs with ingredients exenatide, liraglutide, sitagliptin, saxagliptin, linagliptin and vildagliptin. All of the products are prescription-only medicines. No pharmaceutical products containing alogliptin is registered. The registered package insert of the products has included safety warnings about the risk of acute pancreatitis. News regarding saxagliptin associated with acute pancreatitis had been released by HSA and was posted on the website of Drug Office on 8 March and 30 August 2012; and by MHRA and was posted on the website of Drug Office on 31 March 2012. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 8 March 2012. Subsequently, the Department of Health (DH) had received a local case report of suspected serious adverse drug reaction of acute pancreatitis with GalvusMet Tab 50/850mg (vildagliptin/metformin) (HK-59044) and a letter to inform healthcare professionals about the adverse drug reaction report was issued on 25 September 2012. The matter was discussed by the Registration Committee of the Pharmacy and Poisons Board and concluded in the meeting held in December 2012 that the Drug Office to remain vigilant on any updated news of the drug for further consideration when necessary. In view of FDA’s announcement, a letter to inform healthcare professionals will be issued. Since the new information is still under FDA’s evaluation, the DH will keep vigilance against any safety updates of the drugs released by FDA and other regulatory authorities, and bring up to Registration Committee for consideration when necessary.
Ends/ Friday, March 15, 2013
Issued at HKT 13:00
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 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 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 findings 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 healthcare professional, and healthcare professionals should continue to follow the prescribing recommendations in the drug labels.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm343805.htm
In Hong Kong, there are 15 registered pharmaceutical products belong to the class of incretin mimetic drugs with ingredients exenatide, liraglutide, sitagliptin, saxagliptin, linagliptin and vildagliptin. All of the products are prescription-only medicines. No pharmaceutical products containing alogliptin is registered. The registered package insert of the products has included safety warnings about the risk of acute pancreatitis. News regarding saxagliptin associated with acute pancreatitis had been released by HSA and was posted on the website of Drug Office on 8 March and 30 August 2012; and by MHRA and was posted on the website of Drug Office on 31 March 2012. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 8 March 2012. Subsequently, the Department of Health (DH) had received a local case report of suspected serious adverse drug reaction of acute pancreatitis with GalvusMet Tab 50/850mg (vildagliptin/metformin) (HK-59044) and a letter to inform healthcare professionals about the adverse drug reaction report was issued on 25 September 2012. The matter was discussed by the Registration Committee of the Pharmacy and Poisons Board and concluded in the meeting held in December 2012 that the Drug Office to remain vigilant on any updated news of the drug for further considerati |
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