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FDA, CDC identify potential infection risk prompting voluntary recall of syringes by BD Medical

May 1, 2018

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)

April 24, 2018

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

January 23, 2018

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 […]

Voluntary Recall of Pharmacist Choice Alcohol Prep Pads

December 5, 2017

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) […]

New England Journal of Medicine Publishes Articles in Conjunction with ISTH 2017

July 10, 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 […]

Breaking Clinical Trial News from Genentech/Roche

February 22, 2017

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 […]

CDC Describes New Method to Detect Specific Antibodies in Inhibitor Development

January 24, 2017

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 […]

FDA Issues Warning New Hepatitis C Drugs Could Reactivate Hepatitis B Virus

October 9, 2016

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 […]

Blood Journal: Analysis of 13 Years of Hemophilia Patient Data

October 9, 2016

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 […]

Update #3: Zika Virus & Blood Supply

August 27, 2016

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 […]

Voluntary Recalls Issued for Additional Lots of Kogenate FS Recombinant Clotting Factor Product

August 11, 2016

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 […]

Voluntary Recalls Issued for Additional Lots of Helixate FS Recombinant Clotting Factor Product

August 11, 2016

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 […]

Update #2: Zika Virus & Blood Supply

August 10, 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 […]

Hepatitis: Not Just For Men

July 28, 2016

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 […]

Voluntary Withdrawals of Helixate FS & Kogenate FS

July 26, 2016

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. […]

Update #4: MASAC Issues Recommendation on SIPPET

June 28, 2016

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 […]

Update #3: SIPPET Study Released

June 14, 2016

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. […]

Gene Editing Removes HIV From Human T-Cells

June 14, 2016

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 […]

Emicizumab Study Results Released in New England Journal of Medicine

May 26, 2016

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 […]

May is Hepatitis Awareness Month

May 1, 2016

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. […]

CDC Releases New Recommendations for Opioid Prescriptions for Chronic Pain

April 26, 2016

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! […]

Zika Virus and the Blood Supply

February 4, 2016

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 […]

New Gene Therapy Treatment Proves Effective In Dogs

February 2, 2016

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 […]

FDA Approves Treatment of Chronic Hepatitis C Genotypes 1 and 4

February 1, 2016

Note: The following is an edited form of a press release from the Food and Drug Administration. The original form of the release can be read here. On Thursday, January 28, the U.S. Food and Drug Administration approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) […]

Update #2: SIPPET Study

December 10, 2015

This past weekend, the American Society of Hematology (ASH), a worldwide organization of 15,000+ medical and scientific experts on blood diseases, held their 57th Annual Meeting to discuss new treatments and research methods. During this meeting, a group of doctors from around the globe presented the findings of the Survey of Inhibitors in Plasma-Product Exposed Toddlers (SIPPET). […]

Pain and Mobility Are Major Problems for Patients with Hemophilia

December 8, 2015

Note: The following originally appeared on MDMagazine.com. New research further supports the understanding that patients with hemophilia suffer from pain and mobility issues, and it went on to uncover which joints are most greatly affected by the condition. Christine Kempton, MD, MSc, from Emory University in Georgia, and colleagues used multiple strategies to find how […]

UPDATE #1: Results of Toddler Inhibitor Study (SIPPET) Announced

November 14, 2015

The American Society of Hemophilia (ASH) released information about their upcoming 57th ASH Annual Meeting, which will be held December 5-8, 2015 in Orlando, Florida. Included in the program information is a paper abstract about the SIPPET study (Survey of Inhibitors in Plasma-Product Exposed Toddlers.) A plenary session with further information will be presented at the […]

HFA Receives Donation of VeinViewer Flex

November 4, 2015

Christie Medical Holdings Inc., a global leader in portable vein imaging systems to aid in venipuncture procedures, has donated a VeinViewer® Flex to the Hemophilia Federation of America (HFA) as part of the Christie CARES philanthropy program. Based in Washington, D.C., the Hemophilia Federation of America serves as a consumer advocate for safe, affordable and […]

HFA Recognizes International Plasma Awareness Week

October 11, 2015

HFA joins Plasma Protein Therapeutic Association (PPTA) and its other Member Companies sponsor the second International Plasma Awareness Week (IPAW) to be celebrated globally October 9-15, 2016. This event is held annually and is designed to: Raise global awareness about source plasma collection Recognize the contributions of plasma donors to saving and improving lives Increase understanding […]

FDA Clears Two New Oral Drugs for Hepatitis C

July 27, 2015

Note: This article originally appeared on Medscape. To read the FDA release on Daklinza (genotype 3), click here. For the FDA release regarding Technivie (genotype 4), click here. The US Food and Drug Administration (FDA) approved two new drugs today for hepatitis C (HCV), one for genotype 3 and the other for genotype 4. The first medication is […]


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