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  • BMJ: ‘Adding a sulfonylurea to metformin looks safer than switching to one’

    BMJ: ‘Adding a sulfonylurea to metformin looks safer than switching to one’

    Wednesday, 25 July 2018 14:07
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    Effect of omega-3 or other fatty acids on heart disease is negligible finds Cochrane review

    Thursday, 19 July 2018 10:36
  • DOACs associated with reduced risk of major bleeding compared to warfarin

    DOACs associated with reduced risk of major bleeding compared to warfarin

    Wednesday, 11 July 2018 13:22
  • Recorded penicillin allergy associated with increased risk of MRSA and C difficile

    Recorded penicillin allergy associated with increased risk of MRSA and C difficile

    Tuesday, 03 July 2018 16:51
  • MPS advises of need for better awareness of cauda equina red flag symptoms

    MPS advises of need for better awareness of cauda equina red flag symptoms

    Wednesday, 09 May 2018 16:01

euromedicat2015July 13 2015

Teratogenicity – the risk of congenital anomaly – is of great importance when making decisions about whether medicines are safe to use during pregnancy. When medicines first become available, however, there is little information to advise women and clinicians about which are safer than others. The EUROmediCAT consortium has been working over the last four years to combine data sources from around Europe in order to create a permanent and reliable platform for providing this kind of advice.

The first trimester of pregnancy represents a crucial stage in the development of unborn infants. As organs are formed and the structure of the body begins to become recognisable, pregnant women must be particularly careful about which medications they use in order to avoid an increased risk of birth defects.

Unfortunately, for this very same reason pregnant women cannot be included in clinical trials for medicines. Human safety data about risk to the foetus when taken in early pregnancy is therefore not readily available when a drug is released to market, and so pregnant women are often presented with the unenviable option of either taking a medication without knowing its potential risk to their unborn child, or avoiding medication altogether and exposing themselves and their child to other potential risks. Between 40-90 per cent of women use at least one medicine during pregnancy, making this a common problem for expectant mothers.

It is fair to say that the amount of human safety data available before the marketing of drugs is not adequate for pregnant women. It is thus of great importance to continue to monitor the safety of drugs as they enter mainstream use. Professor Helen Dolk of Ulster University, however, believes that current efforts to provide this post-marketing safety data are underfunded and inadequate. “There is a rather ad hoc approach to reproductive pharmacovigilance in general in Europe, with too little investment in research and surveillance,” she says. “A lot relies on the initiative of individuals to build systems. Many groups exist – for example congenital anomaly registries collect medication data, and teratogen information systems that provide information about medication safety to women or clinicians also collect data – but there is little coordination and investment to ensure that a systematic and early warning system is in place.”

Building a system for reliable advice

Dolk has led a pre-existing congenital anomaly registry network called EUROCAT, covering nearly one third of births in the European Union, for the last fifteen years, but it has not had sufficient funding to develop its postmarketing medication safety surveillance. However, a recent European project called EUROmediCAT has helped to change this. It has combined data from EUROCAT with existing healthcare data and expertise in order to develop and test an efficient system for safety evaluation of drugs during pregnancy.

Linking registry data to electronic prescription data has been an integral part of the project’s push to systemise and formalise the use of available resources. Electronic health databases are widely used across Europe and are easier to access than ever before, but until now the opportunity to use these valuable tools in conjunction with data on congenital anomalies had not been taken. “As this had not been done before, a large portion of our work in EUROmediCAT has been proving the concept that a system can be created that will bring an improvement to the information provided about certain drugs,” explains Dolk.

The focus on system building illustrates the project’s ambition to create something more long lasting than a standalone piece of research. It is of great importance that information is available on each one of the many new drugs that enter the marketplace each year, and to perform this sizeable task to the high standard that is required it must be done methodically and reliably. The incidence of any congenital anomaly due to a specific type of medication is often low, and so with smaller datasets it is easy for some risks to go undetected. It is only after the analysis of large pools of data using a variety of controlled studies that patterns start to emerge. The pooling of information in EUROmediCAT will thus help to identify specific risks associated with new drugs as quickly as possible.

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