All pregnancies reported during PEM studies are followed up by the medical and scientific staff of the DSRU in order to determine the outcome in those babies exposed during pregnancy to the drugs being monitored.
A review (Wilton et al., 1997) showed that 2508 pregnancies have been followed up in 34 PEM studies. The study drug was known to have been dispensed during 904 of these pregnancies (839 during the first trimester and 65 during the second/third trimesters). The first trimester pregnancies produced 553 live births among which 20 (3.6%) abnormalities were reported. The findings are little different from the proportion of abnormalities reported in the general population in the United Kingdom. Thus, these observational data may be of value to those who need to advise pregnant women exposed to newly marketed medicines. The pregnancy database of PEM is expanding. Moreover, the DSRU currently is analysing the pregnancy exposure data with the application of comparative statistical methods between products in the PEM database or with external data, e.g. national statistics of congenital abnormalities, and the results will be published in due course.
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