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February 2009
Volume 19 Issue 2
Patient Care and Science
Drug Approvals, Recalls, Adverse Events Update

IDSA offers two e-mail services to help members stay informed of updates from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Recent alerts have included:

IDSA members can sign up for these services online. (You must be logged in to have access to this link.)

In addition, FDA has given notice that it is reviewing safety data for drotrecogin alfa (activated), marketed as Xigris, following a study (Gentry et al., Crit Care Med 2009;37:19-25) that reported an increased risk of serious bleeding events and death in patients with sepsis and baseline bleeding risk factors who received this product.

FDA notes the findings in this study are consistent with the information in the current product label and the agency is not recommending any changes in practice at this time. The agency will communicate its conclusions and any resulting recommendations to the public when the review is completed, which may take several months. FDA urges both health care professionals and patients to report side effects from the use of drotrecogin alfa to the  FDA's MedWatch Adverse Event Reporting program.


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