FDA Drug Safety Communication: Addition of another concentration of liquid acetaminophen marketed for infants

Safety AnnouncementAdditional Information for Patients Additional Information for Healthcare Professionals Additional Background Information   Safety Announcement [12-22-2012] The U.S. Food and Drug Administration (FDA) is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available at local stores. Until now, liquid acetaminophen marketed for infants was…

FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod)

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [12-20-2011] The U.S. Food and Drug Administration (FDA) has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted…

FDA Drug Safety Communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events

  This update is in follow-up to the FDA Drug Safety Communication on July 21, 2011 about Multaq (dronedarone) and increased risk of death and serious cardiovascular events    Safety Announcement Data Summary   Safety Announcement [12-19-2011] The U.S. Food and Drug Administration (FDA) has completed a safety review of the heart drug Multaq (dronedarone). This…

FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Public Health Advisory in July 2006 on this potential risk was based on a single published study.  Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.   …

FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults

This update is in follow-up to the FDA Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD).  Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [12-12-2011] The U.S. Food and Drug Administration (FDA) is updating its communication on the ongoing cardiovascular safety review…

FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [12-7-2011] The U.S. Food and Drug Administration (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial…

FDA Drug Safety Communication: Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag)

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [12-6-2011] The U.S. Food and Drug Administration (FDA) has approved modifications to the Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs Nplate (romiplostim) injection and Promacta (eltrombopag) tablets. The modifications include the removal of certain elements of the REMS, including the…