Where Am I? -> PREVENTION & RISK FACTORS -> Medication During Pregnancy -> Medication Introduction
Direct link to this page: http://www.eurocat-network.eu/PREVENTIONAndRISKFACTORS/MedicationDuringPregnancy/MedicationIntroduction

 

Medication Introduction

 

 

Objectives

1.  To develop and implement postmarketing surveillance of teratogenic risks of drugs taken during pregnancy

2.  To focus on risk associated with maternal chronic diseases.


Description of Work

Pharmacovigilance

We are building a reproductive pharmacovigilance system “EUROmediCAT” based on the successful recent developments in EUROCAT. The aims of the system are to provide early warning regarding risk of congenital anomalies related to medication, to test signals generated by pregnancy registers and other sources, and to monitor whether known teratogens have been successfully avoided during pregnancy.  EUROmediCAT has been successful in attracting Framework 7 funding, due to start January 2011.  EUROmediCAT will enhance exposure data by linkage of registries to presecription data, and will concentrate on new anti-epileptics, insulin analogs, anti-asthmatics and anti-depressants.

EUROCAT Central Registry at the University of Ulster and the University of Groningen is also involved in the ENCCeP network of the European Medicines Evaluation Agency (EMEA). This is an important forum for pharmacovigilance. A code of conduct for scientific independence and transparency is being developed, particularly for industry funded pharmacovigilance studies.  

University of Groningen is partner in the PROTECT consortium funded by IMI funding led by EMEA. As partner to this project, the University of Groningen will seek to make it relevant to EUROCAT's work on improving information about drug exposure during pregnancy.

Anti-Epileptic Drug Studies

In 2007, EUROCAT created a EUROCAT Antiepileptic database including data from 19 registries, 1995-2005. This dataset was used to conduct a case-control study evaluating the risk of orofacial clefts in relation to lamotrigine exposure.  (Dolk, 2008). Studies related to Valproic Acid (VPA) and Carbamazepine and specific birth defects are ongoing.  Both publications can be expected end 2010.    Further funding from Glaxo Smith Kline has been obtained to continue the Lamotrigine Study to 2013.

Validation of ATC-Codes

Since 2005, the existing drug variables in the EUROCAT dataset were modified to use the ATC drug code.  Nineteen registries transmit ATC drug codes. We are checking and summarising these data to develop quality indicators to improve drug data collection within the EUROCAT database.

 

Members of the EUROCAT Drug Working Group 

     Marie-Claude Addor (Vaud, Switzerland)

     Larraitz Arriola (Basque Country, Spain)

     Marian Bakker (North Netherlands)

     Ingeborg Barisic (Zagreb, Croatia)

     Fabrizio Bianchi (Tuscany, Italy)

     Elisa Calzolari (Emilia Romagna, Italy)

     Lolkje de Jong-van den Berg (University of Groningen) - Leader

     Helen Dolk (EUROCAT Central Registry)

     Berenice Doray (Strasbourg, France)

     Ester Garne (Odense, Denmark)

     Miriam Gatt (Malta)

     Lorentz Irgens (Norway)

     Janneke Jentink (Netherlands)

     Babak Khoshnood (Paris, France)

     Anna Latos-Bielenska (Poland)

     Maria Loane (EUROCAT Central Registry)

     Anna Materna-Kiryluk (Poland)

     Jan Mejnartowicz (Poland)

     Vera Nelen (Antwerp, Belgium)
     Amanda Neville (Emilia Romagna, Italy)

     Mary O'Mahony (Cork & Kerry, Ireland)

     Annette Queisser-Luft (Mainz, Germany)

     Anks Rissmann (Saxony-Anhalt, Germany)

     Francesca Riviera (Emilia Romagna, Italy)

     David Tucker (Wales, UK)

     Christine Verellun-Dumoulin (Hainaut-Namur, Belgium)

     Awi Wiesel (Mainz, Germany)