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  Safety AnnouncementAdditional Information for Patients and ConsumersAdditional Information for Healthcare ProfessionalsData Summary (Tables)   Safety Announcement [02-08-2012] The U.S. Food and Drug Administration (FDA) is informing the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A…

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We seek to build a coalition of public and private healthcare organizations with expertise in product use, risk management, standard setting, and many other areas of quality care and safety. Together, we can development and implement effective risk reduction strategies for preventing surgical fires.We welcome other organizations who want to join in the Preventing Surgical Fires…

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [01-20-2012] The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection associated with…

Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.  FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines…

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [1-13-2012] The U.S. Food and Drug Administration (FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin)….

This update is in follow-up to the Drug Safety Communication: FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients issued on 7/26/2011. Safety Announcement [1-12-2012] The U.S. Food and Drug Administration (FDA) is updating healthcare professionals and the public about preliminary findings from ongoing…

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [03-04-2011] The U.S. Food and Drug Administration (FDA) is removing the warning related to liver injury from the boxed warning of the Letairis (ambrisentan) tablet label. Further evaluation of the clinical trial data and post-marketing safety information has led the FDA to conclude…

Safety Announcement [01-05-2012] The U.S. Food and Drug Administration (FDA) is informing the public that a recent clinical trial with Doribax (doripenem) was stopped early because of significant safety concerns. This trial, which was evaluating the effects of Doribax on treatment of patients with ventilator-associated pneumonia, demonstrated excess mortality and a numerically poorer clinical cure…