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PLoS Medicine Issue Image | Vol. 8(9) September 2011

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Why Drug Safety Should Not Take a Back Seat to Efficacy

In this month’s editorial, the PLoS Medicine Editors argue that methodological challenges in monitoring the safety of prescription medications should not mean that drug safety be considered less important a topic of study than efficacy. The Editors also highlight the debates that continue about the best ways to meaningfully synthesize and interpret data on the possible harmful effects of drugs—for example, how passive surveillance systems (spontaneous reports of suspected adverse reactions) should be improved, whether new drugs should go through a phased launch process with enhanced safety evaluations, and how appropriate risk mitigation strategies are for drugs with safety concerns. Also published this month, a research article by Patricia McGettigan and David Henry reevaluates the evidence from observational studies on the cardiovascular risk associated with non-steroidal anti-inflammatory drugs (NSAIDs). In this systematic review report, the authors provide estimates of the comparative risks with individual NSAIDs at typical doses in community settings. The authors conducted literature searches and pooled adjusted estimates of relative risks (RRs) for cardiovascular events with use of individual NSAIDs, by dose, and in populations with low and high background risks and compare individual drugs in pairwise analyses generating ratios of relative risks (RRRs).

Image Credit: Kristine Paulus at flickr.com

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Why Drug Safety Should Not Take a Back Seat to Efficacy

In this month’s editorial, the PLoS Medicine Editors argue that methodological challenges in monitoring the safety of prescription medications should not mean that drug safety be considered less important a topic of study than efficacy. The Editors also highlight the debates that continue about the best ways to meaningfully synthesize and interpret data on the possible harmful effects of drugs—for example, how passive surveillance systems (spontaneous reports of suspected adverse reactions) should be improved, whether new drugs should go through a phased launch process with enhanced safety evaluations, and how appropriate risk mitigation strategies are for drugs with safety concerns. Also published this month, a research article by Patricia McGettigan and David Henry reevaluates the evidence from observational studies on the cardiovascular risk associated with non-steroidal anti-inflammatory drugs (NSAIDs). In this systematic review report, the authors provide estimates of the comparative risks with individual NSAIDs at typical doses in community settings. The authors conducted literature searches and pooled adjusted estimates of relative risks (RRs) for cardiovascular events with use of individual NSAIDs, by dose, and in populations with low and high background risks and compare individual drugs in pairwise analyses generating ratios of relative risks (RRRs).

Image Credit: Kristine Paulus at flickr.com

https://doi.org/10.1371/image.pmed.v08.i09.g001