Other safety alerts
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| European Union: European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type 2 diabetes |
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The European Medicines Agency (EMA) is investigating findings by a group of independent academic researchers that suggest an increased risk of pancreatitis (inflammation of the pancreas) and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with so-called GLP-1-based therapies (glucagon-like peptide 1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors). GLP-1-based therapies are also known as incretin mimetics.
In the EU they include exenatide (Byetta, Bydureon), liraglutide (Victoza), lixisenatide (Lyxumia), sitagliptin (Efficib, Januvia, Janumet, Ristaben, Ristfor, Tesavel, Velmetia, Xelevia), saxagliptin (Komboglyze, Onglyza), linagliptin (Jentadueto, Trajenta) and vildagliptin (Eucreas, Galvus, Icandra, Jalra, Xiliarx, Zomarist).
The findings are based on examination of a small number of pancreatic tissue samples obtained from organ donors with and without diabetes mellitus, who died due to causes other than diabetes. The Agency’s Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) are currently investigating the information provided by the researchers to determine the need for possible further regulatory action.
The Agency has not reached any conclusions on this investigation. There is currently no change to the recommendations on the use of these medicines and no need for patients to stop taking their medicines. Healthcare professionals should continue to prescribe these medicines in accordance with the product information.
Effects on the pancreas were identified as a possible risk for these medicines during their initial evaluation for marketing authorisation due to their mechanism of action, and rare cases of pancreatitis have been reported. Warnings for patients and healthcare professionals are included in the product information for all these medicines. In addition, the risk management plans for these medicines instruct the marketing-authorisation holders to closely monitor for adverse effects on the pancreas.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_001753.jsp&mid=WC0b01ac058004d5c1
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 lixisenatide 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. News regarding the pancreatic risks with incretin mimetic drugs has been released by FDA and was posted on the website of Drug Office on 15 March 2013, and a letter to inform healthcare professionals was issued on the same day. Since the pancreatic risks with incretin mimetic drugs are still under evaluation, the DH will keep vigilance against any safety updates of the drugs released by other regulatory authorities, and bring up to Registration Committee for consideration when necessary.
Ends/ Wednesday, March 27, 2013
Issued at HKT 13:00 |
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