Donate

Medical News

Genentech Issues Statement on Hemlibra Particles; MASAC Responds

October 7, 2019

Today, Genentech provided the following statement regarding reports of particulate matter in vials of Hemlibra. You can read Genentech鈥檚 statement below, and can read comments on the statement from NHF鈥檚 Medical and Scientific Advisory Council (MASAC). The events of the past several months, including today鈥檚 announcement by Genentech, underscore the importance of the joint Safety […]

FDA Identifies Biomarker for Immune Response to FVIII Products Used to Treat Hemophilia A

September 17, 2019

The following is a press release from the FDA. Read the press release on the FDA website聽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

August 28, 2019

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 […]

RECALL NOTICE: Bayer Voluntarily Recalling Factor 8 Product

July 19, 2019

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庐 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 […]

SPECIAL PRESIDENT AND CEO ANNOUNCEMENT

July 16, 2019

Dear Bleeding Disorders Community 鈥 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.聽 I love HFA but ultimately this is just the […]

Recall Notice: Fentanyl Transdermal Pain Patches Recalled Due to Product Mislabeling

April 23, 2019

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 Voluntarily Recalls Profilnine

June 15, 2018

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 […]

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聽here. 聽 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鈥檚 update issues recommendations for providers and patients in case of […]

Hemophilia Puts Damper on Patients鈥 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聽hemophilia聽interferes with patients鈥 sexual activity and is linked to worse health status. The study titled 鈥淪exual 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聽on December 5, 2017 outlining a voluntary recall by聽Simple Diagnostics of聽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聽form of an article from the聽Centers for Disease Control and Prevention(CDC). The original full-length of the article聽can be read聽here. The Centers for Disease Control and Prevention (CDC), along with researchers from聽the聽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聽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. 鈥淚n 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聽lots of Kogenate聽FS with vial adapter. This is an update to the recall that was issued on July 25, 2016.聽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聽lots of Helixate FS with vial adapter. This is an update to the recall that was issued on July 25, 2016.聽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鈥檚 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聽Survey of Inhibitors in Plasma Products Exposed Toddler (SIPPET)聽The SIPPET study was published in the聽New England Journal Of Medicine (NEJM)聽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聽New England Journal Of Medicine (NEJM)聽published the results of the聽Survey of Inhibitors in Plasma Products Exposed Toddler (SIPPET)聽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:聽Scientific Reports聽released an article outlining the results of a study聽by researchers at Temple University offers promising new advancements toward a cure for HIV. 聽Using specialized gene-editing, 聽researchers were able to聽effectively and safely聽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,聽Emicizumab (ACE910, Chugai Pharmaceuticals), that shows reduced bleeding in patients with severe hemophilia A. Read the full article,聽Factor VIII鈥揗imetic 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鈥檝e 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聽here. A single injection. That鈥檚 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 […]


Sign up for E-mails, Dateline Magazine, and other ways to stay connected.