Hemophilia Federation of America is a national nonprofit organization that assists, educates and advocates for the bleeding disorders community.
Today, Genentech provided the following statement regarding reports of particulate matter in vials of Hemlibra. You can read Genentech’s statement below, and can read comments on the statement from NHF’s Medical and Scientific Advisory Council (MASAC). The events of the past several months, including today’s announcement by Genentech, underscore the importance of the joint Safety […]
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 […]
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 […]
The following is a press release from Bayer regarding a voluntary recall. PATIENTS SHOULD NOT USE THIS PRODUCT! Bayer is voluntarily recalling two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain […]
Dear Bleeding Disorders Community — I want to let you know that I will be stepping down from HFA as your President and CEO at the end of August. Leaving HFA has been an incredibly difficult decision I have been wrestling with for about a year. I love HFA but ultimately this is just the […]
The following is from the FDA MedWatch. Read the recall notice in its entirety here. Alvogen Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. A small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. The 50 mcg/h patches that […]
Grifols Biologicals is initiating a voluntary product recall of one lot of Profilnine. Grifols Biologicals has determined there is low risk to the patient associated with this issue; however, Grifols Biologicals is requesting the lot to be returned out of caution. Therapy Plasma Product NDC Number Lot Number Size Packaging Expiration Date 68516-3208-2 A1PBB00072 1000 […]
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 […]
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 […]
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 […]
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 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 […]
The following is the full statement from Genentech/Roche regarding the recent death of a 41-year-old hemophilia with inhibitors patient who was participating in the HAVEN 1 study. Dear members of the Haemophilia community, At Roche, we respect and value the close relationships that exist within the haemophilia community. We also understand the important role patient […]
Note: The following is an abridged form of an article from the Centers for Disease Control and Prevention(CDC). The original full-length of the article can be read here. The Centers for Disease Control and Prevention (CDC), along with researchers from the Hemophilia Inhibitor Research Study (HIRS), have recently published two articles in The Journal of Thrombosis and Haemostasis. The articles describe […]
The following is excerpted from an FDA news release. To read the release in its entirety, click here. The U.S. Food and Drug Administration is warning about the risk that some of the new direct-acting antiviral medicines for hepatitis C (HCV) can reactivate the hepatitis B virus (HBV) among patients who have had HBV. “In a […]
A recent article in Blood, a publication of the American Society of Hematology, examines thirteen years of surveillance data collected by the Centers for Disease Control and Prevention regarding patient outcomes for men with severe hemophilia. Among the key points: Prospectively collected data on demographics, complications, and mortality are described for 4899 US men with […]
On August 26th, the US Food and Drug Administration issued a revised guidance to US blood banks addressing Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components. The Zika virus is transmitted primarily by the Aedes mosquito; it can also be spread by sexual contact. Although 4 out of 5 […]
Bayer has announced a voluntary recall of additional lots of Kogenate FS with vial adapter. This is an update to the recall that was issued on July 25, 2016. All lot numbers affected by the July 25, 2016 recall and August 10, 2016 extension are: Product Lot Number Expiration Date Kogenate FS 250 IU Vial Adapter 270RV8X 12/19/2017 […]
CSL Behring has announced a voluntary recall of additional lots of Helixate FS with vial adapter. This is an update to the recall that was issued on July 25, 2016. All lot numbers affected by the July 25, 2016 recall and August 10, 2016 extension are: Product Lot Number Expiration Date Helixate FS 250 IU 270P892 09/15/2016 […]
For the past few months, HFA has been monitoring the progression of the Zika virus in the United States. Since the first reported cases of Zika virus reaching the United States in January, there have been thousands of additional cases. According to the Centers for Disease Control (CDC), the follow cases and causes of transmission […]
I have severe factor 1 deficiency (afibrinogenemia) and have been Hepatitis C (HCV) positive since 1998. My source of infection was one of my many cryoprecipitate infusions (cryo being the only available treatment for anyone with factor 1 deficiency until 2009, and for me until November 2014). What makes me different than most people with […]
As part of HFA’s ongoing mission to assist and advocate for the bleeding disorders community, this medical news is being issued to keep you informed about product safety. About These Withdrawals CSL Behring is initiating a voluntarily recall of two lots of its hemophilia A drug Helixate FS containing active ingredient manufactured before November 2015. […]
On June 28, 2016, the National Hemophilia Foundation’s Medical and Scientific Advisory Committee (MASAC) issued a recommendation following the published results of the Survey of Inhibitors in Plasma Products Exposed Toddler (SIPPET) The SIPPET study was published in the New England Journal Of Medicine (NEJM) in May 2016. The full text of the SIPPET study is available for a […]
On May 26 2016, the New England Journal Of Medicine (NEJM) published the results of the Survey of Inhibitors in Plasma Products Exposed Toddler (SIPPET) study. Investigators found that in a randomized study, when previously-untreated patients (PUPs) were treated with recombinant factor VIII, there was an 87% higher incidence of inhibitor development than when treated with plasma-derived factor VIII. […]
Note: Scientific Reports released an article outlining the results of a study by researchers at Temple University offers promising new advancements toward a cure for HIV.  Using specialized gene-editing,  researchers were able to effectively and safely eliminate HIV-1 from the DNA of human T-cells. This study is especially promising in that there appear to be very little to no side […]
Note: The New England Journal of Medicine released an article outlining the results of a study of a new drug, Emicizumab (ACE910, Chugai Pharmaceuticals), that shows reduced bleeding in patients with severe hemophilia A. Read the full article, Factor VIII–Mimetic Function of Humanized Bispecific Antibody in Hemophilia A, in the New England Journal of Medicine. This video […]
In 2001, the Centers for Disease Control (CDC) and Prevention designated the month of May as Hepatitis Awareness Month to bring awareness and attention to those living with viral hepatitis. In the 1980s and 1990s, thousands of people with hemophilia contracted HIV and Hepatitis C (HCV) from the contaminated blood supply transmitted by clotting factorproducts. […]
Note: The following is an edited form of a press release from the Centers for Disease Control and Prevention (CDC). The original form of the release can be read here. To read more about pain issues in the hemophilia community, please visit these resources from HFA: Opioids, Addiction, & Bleeding Disorders Pain Toolkit Webinar: Ouch! […]
We’ve recently received questions from the bleeding disorders community about the Zika Virus and the possibility of transmission via the blood supply. Zika is primarily transmitted through the bite of infected Aedes mosquitoes, the same mosquitoes that spread Chikungunya and dengue. HFA has been in contact with the Centers of Diseases and Control (CDC) and […]
Note: The following is an edited form of a press release from the University of North Carolina School of Medicine. The original release can be read here. A single injection. That’s all someone with a factor VII deficiency would need for a life-long cure, thanks to a new gene therapy treatment developed in a collaboration of […]
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