WFH & NHF Issue Joint Statement Regarding Two Deaths Reported in Orphan Disease Gene Therapy Clinical Trial
The following is information from the World Federation of Hemophilia. A joint World Federation of Hemophilia (WFH) and National Hemophilia Foundation (NHF) statement* is issued on two deaths reported in orphan disease gene therapy clinical trial (*on behalf of the WFH Coagulation Product Safety, Supply, and Access Committee):We have become aware of two patient deaths […]
FDA Communication: Important Information for Potential Donors of Blood and Blood Products
The following is an excerpt from a recent communication from the United States Food and Drug Administration. Read the full communication here:The Food and Drug Administration (FDA) would like to remind the public that individuals who have ever tested positive for HIV (the virus that causes AIDS) should not donate blood, because of the potential […]
FDA Identifies Biomarker for Immune Response to FVIII Products Used to Treat Hemophilia A
The following is a press release from the FDA. Read the press release on the FDA website here. Scientists at the U.S. Food and Drug Administration developed a technique that enables them to determine whether immune system cells called dendritic cells appear primed to trigger the production of antibodies against Factor VIII (FVIII) products used to […]
FDA Issues a MedWatch Safety Alert Regarding Certain Hepatitis C Medications
The following is an excerpt from a FDA MedWatch Safety Alert. Read the full safety announcement here.FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.FDA identified 63 […]
FDA, CDC identify potential infection risk prompting voluntary recall of syringes by BD Medical
The following is an alert from BD Medical. Read the full consumer letter with detailed product information here.  Out of an abundance of caution and in the interest of public health, BD is voluntarily recalling certain lots of BD PosiFlush™ Heparin Lock Flush and BD™ Pre-Filled Normal Saline Flush syringes due to a potential for […]
MASAC Issues Safety Information Update on Emicizumab (HEMLIBRA)
The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) has released a safety information update about Emicizumab (Hemlibra), a new subcutaneous treatment for hemophilia A patients with inhibitors. This update has been released following the first report of an anti-drug antibody to Emicizumab. MASAC’s update issues recommendations for providers and patients in case of […]
Hemophilia Puts Damper on Patients’ Sex Life and Health Status, Study Reports
Study Shows Sexual Intimacy Correlates With More Bleeds The following is an excerpt from Hemophilia News Today. Read the entire article here. Researchers report that hemophilia interferes with patients’ sexual activity and is linked to worse health status.The study titled “Sexual Health in Patients with Hemophilia; The Insights from the Patient Reported Outcomes, Burdens and Experiences (PROBE) […]
Voluntary Recall of Pharmacist Choice Alcohol Prep Pads
MedWatch, the FDA safety information and adverse event reporting program released a safety alert on December 5, 2017 outlining a voluntary recall by Simple Diagnostics of three lots of Pharmacist Choice Alcohol Prep Pads due to the lack of sterility assurance and other quality issues. The affected lots are: SD2070421201 (Exp. 12/2019)SD2070420925 (Exp. 09/2019)SD2070420601 (Exp. 12/2019) The full […]
New England Journal of Medicine Publishes Articles in Conjunction with ISTH 2017
The New England Journal of Medicine has published two articles and an editioral in conjunction with the International Society of Thrombosis and Haemostasis meeting being held in Berlin, Germany, July 8-13, 2017. The articles include information on novel hemophilia treatment products currently in clinical trial. Click on the links below to read the articles in […]
Bioverativ Strengthens Commitment To Women With Bleeding Disorders
Bioverativ joins the global hemophilia community in recognizing World Hemophilia Day and supporting the millions of women and girls impacted by bleeding disorders through this year’s theme, “Hear Their Voices.”Excerpted from the press release: “Bioverativ shares the World Federation of Hemophilia’s commitment to understanding the needs of all members of the bleeding disorders community, including women, […]