Blood Substitutes Linked to Deaths, MI; FDA Should Have Acted Sooner to Stop Trials, Researchers Say
People treated with blood substitutes in clinical trials over the past two decades were 30% more likely to die and had almost a threefold higher rate of myocardial infarction (MI) than patients in control groups, a new meta-analysis suggests [1]. Even more damning, the authors of the study say that the US Food and Drug […]
FDA Goes After ‘Natural’ HRT Claims
Todd ZwillichFederal regulators warned several pharmacy companies Wednesday to stop marketing so-called "natural" hormone replacement therapy, calling their sales to women "false and misleading." The FDA took aim at seven compounding pharmacy companies that it says use a product called estriol in reformulated hormone replacement therapy for women.
FDA Safety Changes: Pexeva, Vfend, Suprane
News Author: Yael WaknineCME Author: Yael Waknine The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise of the risk for serotonin syndrome in patients receiving concomitant treatment with paroxetine mesylate and triptans, drug interactions between voriconazole and efavirenz requiring dose adjustments for both drugs when used concomitantly, and the risk […]
FDA Warns of Counterfeit Prescription Drugs Purchased Online
Yael WaknineThe US Food and Drug Administration (FDA) is warning consumers and healthcare professionals of the risk for obtaining counterfeit drugs when purchasing prescription medications online, according to a news release.
FDA MedWatch: Welch Allyn AED 10 Automatic External Defibrillators
FDA MedWatch: Welch Allyn AED 10 Automatic External Defibrillators manufactured between 3/29/07 and 8/9/07 – Class 1 Recall MedWatch – The FDA Safety Information and Adverse Event Reporting Program FDA issued a Class I recall for Welch Allyn AED 10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, […]
Subject: FDA- MedWatch- Aprotinin Injection (marketed as Trasylol)
Subject: FDA- MedWatch- Aprotinin Injection (marketed as Trasylol)- Patient Enrollment In The Aprotinin Treatment Group Arm of BART Study Stopped MedWatch – The FDA Safety Information and Adverse Event Reporting Program FDA informed healthcare professionals of the Data Safety Monitoring Board's recommendation to stop patient enrollment in the aprotinin treatment group arm of the Blood […]
FDA MedWatch: Trasylol (aprotinin injection)
FDA MedWatch: Trasylol (aprotinin injection) – FDA requests marketing suspension and Bayer Pharmaceutical Corp. has agreed, pending a detailed review of preliminary results from a Canadian study that suggested an increased risk for death MedWatch – The FDA Safety Information and Adverse Event Reporting Program FDA announced that, at the agency's request, Bayer Pharmaceuticals Corp. […]
Updated Warfarin (Coumadin) labeling includes new genetic information
FDA – MedWatch – Updated Warfarin (Coumadin) labeling includes new genetic information that may help providers improve initial dosing estimates of anticoagulant for individual patients
Baxter Healthcare Corp. Recalls Baxter COLLEAGUE And FLO-GARD
FDA – MedWatch – Baxter Healthcare Corp. Recalls Baxter COLLEAGUE And FLO-GARD Volumetric Infusion Pumps Because Of Falsification Of Service And Repair Data
Baxter Healthcare Corp. and FDA notified healthcare professionals
FDA – MedWatch – Baxter Healthcare Corp. and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163.
