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April 15, 2010
FDA Announcement on Heparin Potency
Effective October 1, 2009, the FDA revised the USP unit for unfractionated heparin with the goal of improving the consistency and quality of heparin and bringing it into line with existing international standards.
February 01, 2010
Follow-Up to the October 2008 Updated Early Communication About an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler)
This is a follow-up to previous Early Communications issued in 2008 by the US Food and Drug Administration (FDA) describing a potential increase in the risk of stroke, heart attack, or death from a cardiovascular cause related to the use of tiotropium, which is marketed as Spiriva HandiHaler.
August 03, 2009
New Review Debates Need for Additional LABA Safety Trials

In a new commentary, Malcolm R. Sears, MD, of McMaster University in Hamilton, ON, Canada, discusses the familiar debate about the safety of using long-acting β2-agonists (LABA) in monotherapy for asthma. The commentary focuses on data provided in the metaanalysis recently undertaken by the FDA of safety outcomes of 60,954 individuals in 110 LABA trials. Results of the analysis found that LABA used with mandatory inhaled corticosteroid (ICS) was not associated with an increased risk of asthma-related mortality, intubations, or exacerbations. Dr.