Wednesday, April 18, 2012

RED BANK, N.J. – Although von Willebrand disease (VWD) is the most common hereditary bleeding disorder in the United States, affecting up to 1 percent of the population, it is often misdiagnosed or under-diagnosed in women. HealthyWomen, the nation’s leading nonprofit health information source for women, has developed new educational materials they hope will shine a light on a disorder that, when undiagnosed and untreated, can severely impact the quality of life for women.

Caused when von Willebrand factor, a protein in the blood that is necessary for clotting, is either missing or not working properly, VWD affects men and women equally. Yet, when undiagnosed and untreated in women, it puts them at a greater risk for life-threatening bleeding following childbirth and for undergoing unnecessary hysterectomies.

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An estimated 1 in 1,000 women and men has a bleeding disorder. However, 75% still receive very inadequate treatment or no treatment at all. What will it take to close the gap?

On World Hemophilia Day 2012 help us “Close the Gap” of care around the world. Together, we can work towards a day when treatment will be available for all globally.

On World Hemophilia Day we want to inspire people to help close the gap and to improve accessibility and quality of care so that Treatment for All becomes a reality.

Join the international bleeding disorders community on April 17 to mark World Hemophilia Day.

“The reality is that most people with hemophilia or other bleeding disorders do not receive adequate diagnosis, treatment, and management for their conditions,” said Mark Skinner, World Federation of Hemophilia (WFH) president. “This is important whether good treatment is already established but needs to be protected or where treatment needs to be improved.”

To learn more about hemophilia and what it is like to live with a bleeding disorder, visit www.wfh.org/whd/en

On World Hemophilia Day, help us Close the Gap.

About hemophilia and other bleeding disorders
Hemophilia, von Willebrand disease, inherited platelet disorders, and other factor deficiencies are lifelong bleeding disorders that prevent blood from clotting properly. People with bleeding disorders do not have enough of a particular clotting factor, a protein in blood that controls bleeding, or else it does not work properly. The severity of a person’s bleeding disorder usually depends on the amount of clotting factor that is missing or not functioning. People with hemophilia can experience uncontrolled internal bleeding that can result from a seemingly minor injury. Bleeding into joints and muscles causes severe pain and disability while bleeding into major organs, such as the brain, can cause death.

About the World Federation of Hemophilia (WFH)
For 50 years, the World Federation of Hemophilia, an international not-for-profit organization has worked to improve the lives of people with hemophilia and other inherited bleeding disorders. Established in 1963, it is a global network of patient organizations in 118 countries and has official recognition from the World Health Organization. Visit WFH online at www.wfh.org

By a GenomeWeb staff reporter

March 14, 2012

NEW YORK (GenomeWeb News) – Medical College of Wisconsin researchers have received a $10 million grant from the National Heart, Lung, and Blood Institute to continue a study of molecular and genetic factors involved in von Willebrand Disease, or VWD, the most common hereditary bleeding disorder.

MCW will use the five-year grant to further a clinical research project that involves 600 families, and other US and international partners, to learn more about the genes and clinical factors involved in causing a deficiency of von Willebrand factor, or VWF, which is required for normal blood clotting.

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Initiated by : Baxter Healthcare
Event Id : 151
Event Date : 03-14-2012
Therapy Gammagard Liquid [Immune Globulin Intravenous (Human)] 10%
NDC Number Lot Number Size Packaging Expiration Date
0944-2700-06 LE12LG70AC 20g vial 11-25-2014

Reason Baxter Healthcare Corporation is voluntarily recalling lot LE12LG70AC of GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)] 10%, 20g size, product code 1502797, NDC# 0944-2700-06. This recall is being conducted as a precautionary measure due to a labeling error noted on the product vial label and unit carton. The labels on the unit carton and product vials indicate an incorrect manufacturing date and expiry date.

Incorrect Manufacturing Date: November 25, 2011
Incorrect Expiration Date: November 25, 2014

Correct Manufacturing Date: November 5, 2011
Correct Expiration Date: November 5, 2014

The Food and Drug Administration has been notified of this action.

Considering the information noted above, the medical assessment into this issue concluded that this labeling error poses negligible safety risk to the patient. This labeling error has no impact on the functionality of the product. Furthermore, stability data indicates the difference of 20 days between the correct expiry date and the printed expiry date has no impact on the product quality. Therefore, if you have already used this product no action is required. However, if you still have any inventory of this product lot, we are asking you to return the product.
Action 1) Please check all product labels against the affected lot number.
2) Do not take this product. Return affected recalled lots to the point of purchase to receive replacement product.
Other Information If you need assistance, please call Stericycle, Inc. at 1-888-873-2838.

HFA Celebrates National Hemophilia Awareness Month
March is Designated to Create Public Awareness about Bleeding Disorders

Washington, D.C. – In 1986, President Ronald Reagan designated the month of March as Hemophilia Awareness Month to bring awareness and attention to those living with a bleeding disorder. Hemophilia Federation of America (HFA) along with chapter organizations across the country commemorates March as National Hemophilia Awareness Month.

“National Hemophilia Awareness Month helps to bring public awareness about bleeding disorders and encourage the development of improved treatment,” said Kimberly Haugstad, Executive Director of HFA. “We are committed to addressing the evolving needs of the bleeding disorders community to help create a better quality of life for all persons with bleeding disorders.”

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By Sarah Aldridge | 02.09.2012
Originally Published in Hemaware February 2012

OJO Images/Glow ImagesThe marketing terms “new and improved” and “longer lasting” are not limited to the latest brand of chewing gum. They also apply to a long list of therapies now in clinical trials for people with bleeding disorders. Some people have waited years for a new recombinant product; others a lifetime for any factor product to treat their rare condition. For many, their patience is about to pay off.

There are more drugs in the pipeline now than in the past few decades. “The companies’ commitment to continue to work on behalf of patients with bleeding disorders is what’s driving it,” says Val D. Bias, CEO of the National Hemophilia Foundation (NHF). The dilemma facing many patients in the future won’t be a lack of medications, but a plethora of products that act in a variety of ways. (See table “Bleeding Disorders Drugs in Human Clinical Trials.”)

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By KAREN BARROW

Published: January 30, 2012

Hemophilia, which affects 20,000 Americans, is a genetic disorder in which the body lacks a clotting factor needed for blood to coagulate. Depending on severity, it can lead to life-threatening, seemingly unprovoked bleeding episodes — or it can go undetected for years, until a serious injury or a routine medical procedure suddenly touches off uncontrolled bleeding.

Hemophilia is more common in boys and men. But some girls and women have the disorder, and it can cause complications during menstruation and childbirth.Hemophilia (actually a group of disorders, marked by different missing blood factors) has no cure. But treatment has improved substantially in recent years. Today many bleeding episodes are prevented by prophylactic injections of the missing factor; until this treatment was developed, patients had to rely on transfusions after a bleeding episode, leaving them vulnerable to infectious diseases and chronic joint damage.

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Go to this link to view Patient Voices: Hemophilia a multimedia feature in the New York Times Health section online.

N Engl J Med 2012; 366:281-283January 19, 2012

ArticleTo the Editor:
Patients with hemophilia A (a deficiency of factor VIII [FVIII]) have spontaneous bleeding because of abnormal thrombin generation, which results in the formation of weak, unstable clots.1 The formation of these weak clots is also the result of delayed and reduced activation of coagulation factor XIII (FXIII).2 The standard treatment is based on FVIII substitution to control and prevent bleeding, but this process is expensive and time-consuming. We hypothesized that supraphysiologic levels of FXIII would normalize clot stability at low levels of FVIII.

Clot stability was recorded by means of the changes in plasma turbidity after the simultaneous addition of tissue factor (dilution, 1:40,000) and tissue plasminogen activator (0.75 nM). FVIII-deficient, platelet-poor plasma, spiked with increasing concentrations of recombinant FVIII plus plasma-derived FXIII or buffer, was compared with normal control plasma. The primary end point was the area under the curve (AUC) for turbidity.

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Study of gene therapy developed at UCL and St. Jude Children’s Research Hospital offers first proof adults with haemophilia B benefit from treatment, reducing need for injections with clotting factor to prevent bleeds.

Symptoms improved significantly in adults with the bleeding disorder haemophilia B following a single treatment with gene therapy developed by researchers at St. Jude Children’s Research Hospital in Memphis, US and demonstrated to be safe in a clinical trial conducted by UCL.

The findings of the six-person study mark the first proof that gene therapy can reduce disabling, painful bleeding episodes in patients with the inherited blood disorder. Results of the Phase I study appear online ahead of print today in the New England Journal of Medicine. The research is also scheduled to be presented on 11 December at the 53rd annual meeting of the American Society of Hematology in San Diego, US.

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