Safety of drugs in pregnancy big news at ICPE
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Safety of drugs in pregnancy big news at ICPE – Kimberley Salmon – Making big news at the 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE: Chicago, Illinois, USA; 14–17 August 2011) this year was the issue of drug safety during pregnancy. This major and often controversial subject was highlighted in a plenary session entitled ‘Thalidomide: 50 Years Later’, which commemorated the 50th anniversary of the thalidomide disaster and reflected on its importance for pharmacoepidemiology. Adding to this thought-provoking session were several poster presentations examining the overall use of prescription drugs during pregnancy, the level of risk management presently in place, and current drug treatments for nausea and vomiting during pregnancy. As ICPE is the premier international conference for pharmacoepidemiology and risk management, it has the potential to influence the field of drug safety in pregnancy through presented and published abstracts. US researchers reviewed 5529 abstracts presented at ICPE during the period 2001–2010, and identified 301 studies focussing on drug safety in pregnancy.1
ICPE’s influence significant They found that, over time, the number of drug utilisation studies decreased, and the number studying birth defects and other pregnancy outcomes increased. The top five most commonly studied drug exposures were antidepressants (15% of studies), anti-infectives (8%), anti-asthmatics (7%), anti-epileptics (5%) and analgesics (3%). According to the researchers, there were trends in exposures studied "that clustered around signals observed in the literature". They contend that the observed trend toward using powerful data sources, robust study designs and relevant endpoints "advances the field of drug safety in pregnancy". The ISPE Medications in Pregnancy Special Interest Group (MiPSIG) was established in August 2006 with the goals of improving the quality of science and expanding the knowledge associated with medication safety during pregnancy. In order to evaluate whether the MiPSIG has made progress in achieving its goals, the researchers again evaluated all 301 abstracts on drug use in pregnancy presented at ICPE over the last 10 years.2 They observed that, after the MiPSIG was implemented, the overall proportion of abstracts focussing on medication use during pregnancy increased from 4% to 6%. There was a drop in studies which focussed solely on the use of drugs during pregnancy, and a rise in those examining the impact of such use on pregnancy, following the MiPSIG’s implementation.
"Notable shift" in quantity and quality The researchers say this "notable shift in the quantity and quality" of abstracts presented at ICPE after implementation of the MiPSIG, and the move towards more sophisticated studies using large national registries and electronic databases focussing on drug impact "enhances our scientific knowledge base". Despite being a known teratogen, thalidomide was approved for multiple myeloma (MM) in Japan in 2008. Investigators from the For
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