European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type 2 diabetes

 

London (March 26, 2013) – The European Medicines Agency 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).

 

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. 


There are also efforts underway to collect safety data on diabetes medicines from independent pharmacovigilance centres across the European Union. The SAFEGUARD study, a study that is funded by the European Commission and carried out within the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), is investigating, among others, evidence for drug-induced pancreatitis for GLP-1-based agents that were authorised before 2011, when the study started.


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). These medicines act like hormones called incretins (hormones produced in the intestine) by increasing the amount of insulin released by the pancreas in response to food. They are authorised for use together with diet and exercise in patients with type 2 diabetes
.

 

  1. This press release, together with all relevant documents is available on the Agency’s website: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/03/news_detail_001753.jsp&mid=WC0b01ac058004d5c1  
  2. The article was published online on 22 March 2013 by Diabetes, a journal of the American Diabetes Association (ADA): http://diabetes.diabetesjournals.org/content/early/2013/03/17/db12-1686.abstract  
  3. The review is carried out under Article 5(3) of Regulation (EC) 726/2004.
  4. More information on the work of the European Medicines Agency can be found on its website: www.ema.europa.eu

 


 

European Medicines agency, 26.03.2013 (tB).

MEDICAL NEWS

Inadequate sequencing of SARS-CoV-2 variants impedes global response to COVID-19
New meta-analysis finds cannabis may be linked to development of…
New guidance on how to diagnosis and manage osteoporosis in…
Starting the day off with chocolate could have unexpected benefits
Better mental health supports for nurses needed, study finds

SCHMERZ PAINCARE

Versorgung verbessern: Deutsche Gesellschaft für Schmerzmedizin fordert die Einführung des…
Pflegeexpertise im Fokus: Schmerzmanagement nach Operationen
Versorgung verbessern: Bundesweite Initiative der Deutschen Gesellschaft für Schmerzmedizin zu…
Jedes vierte Kind wünscht bessere Schmerzbehandlung
Lebensqualität von Patienten in der dauerhaften Schmerztherapie mit Opioiden verbessern

DIABETES

„Wissen was bei Diabetes zählt: Gesünder unter 7 PLUS“ gibt…
Toujeo® bei Typ-1-Diabetes: Weniger schwere Hypoglykämien und weniger Ketoazidosen 
Bundestag berät über DMP Adipositas: DDG begrüßt dies als Teil…
Mit der Smartwatch Insulinbildung steuern
Verbände fordern bessere Ausbildung und Honorierung von Pflegekräften für Menschen…

ERNÄHRUNG

Wie eine Diät die Darmflora beeinflusst: Krankenhauskeim spielt wichtige Rolle…
DGEM plädiert für Screening und frühzeitige Aufbautherapie: Stationäre COVID-19-Patienten oft…
Führt eine vegane Ernährungsweise zu einer geringeren Knochengesundheit?
Regelmässiger Koffeinkonsum verändert Hirnstrukturen
Corona-Erkrankung: Fehl- und Mangelernährung sind unterschätze Risikofaktoren

ONKOLOGIE

Anti-Myelom-Therapie mit zusätzlich Daratumumab noch effektiver
Positive Ergebnisse beim fortgeschrittenen Prostatakarzinom: Phase-III-Studie zur Radioligandentherapie mit 177Lu-PSMA-617
Lymphom-News vom EHA2021 Virtual. Alle Berichte sind nun online verfügbar!
Deutsch-dänisches Interreg-Projekt: Grenzübergreifende Fortbildungskurse in der onkologischen Pflege
Sotorasib: Neues Medikament macht Lungenkrebs-Patienten Hoffnung

MULTIPLE SKLEROSE

NMOSD-Erkrankungen: Zulassung von Satralizumab zur Behandlung von Jugendlichen und Erwachsenen
Verzögerte Verfügbarkeit von Ofatumumab (Kesimpta®)
Neuer Biomarker bei Multipler Sklerose ermöglicht frühe Risikoeinschätzung und gezielte…
Multiple Sklerose beginnt oft lange vor der Diagnose
Goldstandard für Versorgung bei Multipler Sklerose

PARKINSON

Meilenstein in der Parkinson-Frühdiagnose
Parkinson-Erkrankte besonders stark von Covid-19 betroffen
Gangstörungen durch Kleinhirnschädigung beim atypischen Parkinson-Syndrom
Parkinson-Agenda 2030: Die kommenden 10 Jahre sind für die therapeutische…
Gemeinsam gegen Parkinson: bessere Therapie durch multidisziplinäre Versorgung