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News and Events

Also see our Archived News screen. Protein-free Recombinant Factor VIII Research Continues
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NIH Consensus Panel Issues Recommendations for Hepatitis C Therapy
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Protein-free Recombinant Factor VIII Research Continues

Drug companies are working to develop a method to produce protein-free recombinant antihemophilic factor (rAHF/PFM). This new category of clotting factor is prepared entirely without the addition of any human or animal raw materials such as albumin in the cell culture, purification, or final formulation. These drug companies expect to complete the clinical trial for rAHF/PFM and file for regulatory approval in the United States and Europe.

The development of a protein-free recombinant clotting factor is in response to the theoretical concerns of virus or disease transmission through the use of human- and animal-derived components during the cell culture and formulation. All currently FDA-licensed recombinant factor VIII concentrates use human albumin or plasma fractions at some point of their preparations.

(Taken from Bloodstone Magazine, an HHS publication, Winter 2002)

NIH Consensus Panel Issues Recommendations for Hepatitis C Therapy

Now that PEG-interferon is used with Ribavirin to treat chronic hepatitis C virus infection (HCV) in adults, the NIH has held a Consensus Conference to review the issues involved in treatment. Such topics as laboratory diagnosis, the natural history of hepatitis, who should be treated, side-effects of treatment, long-term results, most effective treatments, and who should have a liver biopsy are discussed. If you would like to know more, visit this site: http://consenus.nih.gov/cons/116/116cdc_intro.htm. This site is a preliminary draft only and is pending comments. NIH Consensus Statements are prepared by a nonadvocate, non-Federal panel of experts, based on:
  1. presentations by investigators working in areas relevant to the consensus questions during a 2-day public session;
  2. questions and statements from conference attendees during open discussion periods that are part of the public session; and
  3. closed deliberations by the panel during the remainder of the second day and morning of the third. The statements presented in the draft are an independent report of the panel and they are not a policy statement of the NIH or the Federal Government.

The statments contacinted in the preliminary draft reflect the panel's assessment of medical knowledge available at the time the statement was written. Thus, it provides a "snapshot in time" of the state of knowledge on the conference topic. When reading the statement, keep in mind that new knowledge is inevitably accumulating through medical research.

See more news on our Archived News screen


January 13, 2004
Project Red Flag Grant Winners Announced
As part of its Project Red Flag: Real talk about women’s bleeding disorders campaign, NHF announced the recipients of its first competition for grant awards. The purpose of the grant program, which is made possible by Project Red Flag sponsors Aventis Behring and the Centers for Disease Control and Prevention, is to stimulate the development of innovative education efforts for women affected by bleeding disorders, and to build a body of outreach strategies, evaluation tools and measurable outcomes. Grants were awarded to 12 chapters and associations working in conjunction with their area hemophilia treatment centers.
For a list of grant winners click here: http://www.hemophilia.org/News/prfnews/prf_01_13_04.htm#grant
Look for more information about the grants that were awarded in the March/April issue of HemAware, as well as the May/June issue, which contains a special section about women and bleeding disorders.
For more information about the Project Red Flag campaign, please contact Anna DeSimone, Project Red Flag coordinator, at (800) 42-HANDI ext. 3705 or Adesimone@hemophilia.org
(Courtesy of www.hemophilia.org)
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January 12, 2004

Mad Cow Disease Update
In December, NHF alerted consumers to the detection of bovine spongiform encephalopathy (BSE), otherwise known as mad cow disease, in a cow slaughtered in Washington state earlier that month. This finding marked the first time BSE has been detected in the United States. As more information became available from investigations conducted by the US Department of Agriculture (USDA), it became apparent that the cow in question was imported to the US from Alberta, Canada, two years earlier. Authorities are continuing to investigate links between the Washington cow and another Alberta cow diagnosed with BSE earlier in the year.
In response to the positive BSE test, USDA initiated a recall of 10,000 pounds of meat products produced from 20 cows slaughtered on the same day and sold to meat producers in Oregon and Washington. They have further issued new regulations to strengthen protections against BSE.
At this time, officials at the US Food and Drug Administration (FDA) have not drawn any connection between the infected cow and blood or blood products. NHF is continuing to monitor this matter closely.
Additional information about BSE and the Washington case is available from the USDA and the FDA. Direct links to these sites are provided below:
United States Department of Agriculture:
http://www.usda.gov/BSE/
United States Food and Drug Administration:
http://www.fda.gov/oc/opacom/hottopics/bse.html
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January 8, 2004

MASAC Recommendation #155
Guidelines for Emergency Department Management of Individuals with Hemophilia
NHF’s Medical and Scientific Advisory Coucil has released its recommendation #155, entitled Guidelines for Emergency Department Management of Individuals with Hemophilia. Individuals with bleeding disorders who go to emergency departments for care may not receive appropriate, expeditious management. This recommendation provides guidelines regarding triage, assessment, diagnostic studies, indications for replacement therapy and treatment.
Click here to view the recommendation: http://www.hemophilia.org/programs/masac/masac155.htm
Similarly the Hemophilia Federation of America hired a firm about three years ago to distribute letters to 4,000 emergency rooms about hemophilia treatment guidelines.
Click here to view the letter:
http://www.tsged.com/Articles/Hemophilia_Letter.htm
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December 21, 2003
ABO Blood Type and Race Affects Measurement of von Willebrand Factor Activity
According to research published in the Journal of Thrombosis and Haemostasis, three different principles can measure the activity of von Willebrand factor (VWF): ristocetin cofactor, collagen binding and activity ELISA. These diagnostic parameters were tested on 123 randomly selected females.
The researchers reported that race differences were seen in all tests except ristocetin cofactor, with Caucasians having lower levels of VWF than African Americans. Those with type O blood had significantly lower levels than non-O subjects. Blood type accounted for 19% of the total variance in VWF:Ag, and race accounted for 7%. These and other variances are partially to blame for the difficulty in defining diagnostic limits for VWD.
Source: Blood Weekly
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December 19th, 2003
The British goverment made an announcement regarding a patient who died after receiving blood six years earlier from a donor who later contracted cariant Creutzfeldt-Jakob disease (vCJD). NHF released a news brief to the community explaining the circumstances of thevCJD case as well as the minister's statement late Friday (12/19/03) afternoon. Mark Skinner has also shared the stated released by the WHF. Please find the WHF's statement below. The NHF statement is available on the website at http://www.hemophilia.org/News/medicalnews/mn_12_19_03.htm.
WFH Statement on Transmission of vCJD by Transfusion


Preliminary Report

The British government has announced an incident in which a patient died after receiving blood six years earlier from a donor who later contracted variant Creutzfeldt-Jakob disease (vCJD). The case is the first report from anywhere in the world of the possible transmission of CJD via blood transfusion.

Case Report: In March 1996, a blood donor, who at the time was free of the signs of
vCJD, donated blood to the National Blood Service. Shortly after, packed red cells from the donation were transfused into a patient over the age of 60 having surgery for a serious illness. The red cells were not subjected to a leuko-reduction procedure.


Although the donor showed no signs of vCJD at the time of donation, he subsequently developed vCJD and died in 1999. The recipient of the donation died in the autumn of 2003 and post-mortem examination of the recipient’s brain confirmed a diagnosis of variant CJD. The link between the donor and the recipient was first reported on December 9, 2003.

Further investigation revealed that the donor gave blood twice in 1996. The second recipient died six months following the transfusion due to a cause unrelated to variant CJD. Plasma from both donations was included in pools of plasma used in the manufacture of therapeutic blood components that included Factor VIII used by patients with hemophilia. It is unclear at this time, exactly who received plasma from the derivatives in the United Kingdom. Patients suspected of having received Factor VIII from these pools have been notified and are being monitored for signs of development of vCJD. No case of vCJD has been reported in any person with hemophilia.

Blood components from donors who subsequently developed vCJD have been transfused into 15 additional recipients, of which five received blood after leuko-depletion had been implemented. The earliest such transfusion was in 1993 and the latest in 2001. All are under health surveillance and to date, no signs of vCJD have developed.

Discussion: Although not proven, it is reasonable to assume that this incident represents a case of transmission of vCJD by blood transfusion for the following reasons: 1) Such transmission has been demonstrated in several animal species and is not unexpected. 2) The cellular components of blood contain the highest concentration of suspected infectious agent for vCJD and, therefore, are more likely to transmit the disease as compared with the other components or derivatives. 3) Leuko-depletion was not used on this donation. 4) The possible incubation period, six years, was appropriate for vCJD transmission via a peripheral route of infection (blood). 5) The age of the recipient was well outside the expected age range for acquired vCJD (15-40 years). 6) The probability of both donor and recipient acquiring the condition from eating contaminated beef would be quite small and is estimated to be 1:20,000 to 1:40,000.

Risk to patients receiving other blood products
The causative agent of vCJD, has been shown to be present in low concentration in the blood of experimental animal models of the disease. White blood cells (which are present in packed red cell transfusions) have a much greater concentration of infectivity than plasma). Plasma derivatives, such as clotting factor concentrates, are manufactured from plasma pools. The lower risk of infection from such concentrates is partly due to two factors: 1) the dilution of a contaminated donation by thousands of uncontaminated donations in the same plasma pool, and 2) the manufacturing process, which includes steps that are known from extensive laboratory studies to remove the infectious agent (e.g., precipitation, filtration, and column chromatography). Based upon animal experiments, the total reduction of infectious material in contaminated plasma has been calculated to be more than a million-fold. (A discussion of this reduction can be found at http://www.wfh.org/Content_Documents/Blood_Safety/vCJD_Bulletin2_revised.pdf)
As a result, health authorities have considered plasma derivatives to be among the lowest risk blood products for vCJD.

Geographic localization of risk
The risk of blood-borne transmission of vCJD is, for practical purposes, restricted to the U.K., where 145 people have died from the disease, and where by far the largest number of individuals have been potentially exposed to ‘mad cow disease’, the cause of the vCJD outbreak. Outside the U.K., only Europe and Japan have had cases of BSE, and the number of affected cattle is extremely small compared with the U.K.. Plasma collected from donors in the U.K. is not currently used for manufacturing plasma clotting factor concentrates. In addition, blood donor screening procedures used around the world have restrictions on donors who have resided in the U.K. and other countries where vCJD has been identified.

Exposure of hemophilia patients in the U.K. to vCJD
Plasma from a number of donors incubating vCJD was used in the U.K. to manufacture plasma-derived blood products prior to policy changes with regard to the use of U.K. plasma. As a result, several hundred hemophilia patients have used these products. These patients have been counseled and are under health surveillance for signs of developing vCJD. Reports indicate that currently, none have developed apparent vCJD.

Summary

• vCJD has occurred in a recipient of a donation of packed cells from a donor who subsequently developed vCJD.
• It is reasonable at this time to accept this as a possible blood transmission of vCJD. This occurrence would not be unexpected from the results of a number of animal experiments. (including transmission in sheep –the subject of previous WFH TSE Bulletins)
• The risk of such occurrences appears to be predominately a risk for recipients of blood components collected in the U.K.
• Donor screening procedures and blood banking policies initiated in countries throughout the world appear to be appropriate to reduce such transmissions to a minimum.
• Presently, clotting factor concentrates manufactured from plasma obtained outside the U.K. appear to carry a very low risk of transmission of vCJD because of the exclusion of potential donors incubating vCJD and the reduction of potential agents by the manufacturing processes. Continued vigilance is important to identify any changes in the level of suspected risk.
• WFH will continue to monitor this situation and we shall keep you informed.

The World Federation of Hemophilia TSE Task Force

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December 2nd, 2003

Obituary: Don Paul Lucas
Both in physical stature and sense of service to the community, Don Paul Lucas was a giant of a man. Most recently, as an active volunteer with his local Western Pennsylvania chapter of NHF, Don Paul was intent on enhancing services to youth and families. The chapter is part of the Lucas family history—Don Paul’s parents were founding members. Don Paul and his wife, Jackie, started the chapter’s youth summer camp—Hot-to-Clot—four years ago, and had just secured an NHF grant for a chapter family retreat weekend to be held next spring. Jackie and Don Paul were a consistent volunteer duo in many efforts.
To read the full obituary, please go to: http://www.hemophilia.org/News/nhfnews/nn_12_02_03.htm

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November 29th, 2003

NHF’s MASAC Recommends Inclusion of Thrombophilia in NHF Research and Educational Efforts
NHF’s Medical and Scientific Advisory Council (MASAC) issued a recommendation that thrombophilia be included in NHF research and educational efforts as part of a series of documents that were approved by the Board of Directors on November 8, 2003. MASAC Document #152 cites flat hemophilia treatment center (HTC) funding and lagging efforts to recruit young physicians into hemophilia care as prime reasons for the communication. Specifically, the document recommends that NHF’s funded research programs be expanded to include thrombophilia. It also calls for advocacy efforts in support of expanded programs at HTCs and continued support for provider education in thrombophilia through NHF programs such as the Annual Meeting.
MASAC also issued transition guidelines for people with bleeding disorders and recommended that insurance companies, government agencies and other third-payers leave decisions about product choice to patients and their physicians by covering whichever product is prescribed.
To read all MASAC documents, go to: http://www.hemophilia.org/programs/masac/masac.htm
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November 25th, 2003

NHF Announces State Advocacy Partnership
NHF is proud to announce a new partnership with Stateside Associates, Inc., to assist the bleeding disorders community with state advocacy tracking and monitoring. This action follows through on the resolution passed by the NHF Board of Directors in June 2003 to explore options for implementing a state advocacy program. Stateside Associates is a 15-year-old firm with an excellent reputation for meeting the state advocacy needs of its clients. Stateside Associates will interact with the bleeding disorders community through NHF's federal government relations firm, MARC Associates. Its services to NHF will include:

> Legislative and regulatory tracking in all 50 states, the District of Columbia and U.S. territories.

> Detailed analysis of tracking information specific to the bleeding disorders community's needs and issues.

> Consulting on issues from experienced analysts and firm partners.

> State advocacy training, expertise and resources.

> Ability to screen and link NHF to state lobbyists when needed.

> Monitoring of state legislative and regulatory organizations.

In addition, NHF will have access to online state advocacy resources, including state legislature directories and contact information for key regulatory agencies. Stateside Associates also will assist in the planning of and participate in NHF state advocacy training workshops. Look for more to come regarding state advocacy on NHF's Web site beginning in January 2004.

Dates Set for 2004 NHF Washington Days
Make plans now to join NHF and bleeding disorder advocates for the 2004 Washington Day program to be held March 10 to 12, 2004 at the Washington Marriott Hotel in Washington, DC. This year's program will closely follow the successful format used last year, beginning with a briefing session at the hotel on the evening of Wednesday, March 10. Advocacy training and Congressional visits will occur on Thursday, March 11, with a full day of state issues and advocacy training to follow on Friday, March 12. More details will be available in the coming weeks.

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November 17th 2003

Hepatitis C Vaccine to be Tested on Humans

A vaccine to prevent infection by the virus that causes hepatitis C will be tested at Saint Louis University. The trials will test the effectiveness of three different strengths of the vaccine. "There is currently no licensed vaccine to protect against the hepatitis C virus," said the lead researcher. "A vaccine to prevent the infection would be an important breakthrough in controlling the spread of the virus." The trial is an initial study to test safety and efficacy of the vaccine. Investigators expect to test the vaccine on 45 healthy people, whose blood will be examined for signs of an immune system response.
Sources: BBC News World Addition and Kintisch, Eli. "St. Louis University Will Test Hepatitis C Vaccine." Saint Louis Post Dispatch. Nov. 18, 2003.

(Courtesy of www.hemophilia.org )

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November 17th, 2003
Transjugular Liver Biopsy Is Safe for Patients with Certain Bleeding Disorders
A recent study by Donna DiMichele, MD, and colleagues at New York Presbyterian Hospital found that transjugular liver biopsies (TJLB) can be safely performed in patients with bleeding disorders. These biopsies are important in the assignment of a correct diagnosis and method of treatment for patients who may suffer from hepatitis C virus. The biopsies are recommended for an assessment of liver inflammation and fibrosis.

The 13 adult patients in the study had either severe to mild hemophilia A or B, von Willebrand disease, factor V or factor XIII deficiencies. The subjects were given hemostasis prophylaxis for one to five days, and each was hospitalized for 48 hours or less.

The study, published in Haemophilia, suggested that "with a coordinated multidisciplinary approach to care, TJLB is a safe, effective and potentially cost-effective alternative to the percutaneous approach in the congenital bleeding disorders populations."

Source: Hepatitis Weekly and Haemophilia 2003;9(5):613-618.
(Courtesy of www.hemophilia.org)
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November 10th, 2003
Addition of a Disulfide Bond to Factor VIIIa Prolongs Its Life in Blood
According to a study in the Journal of Thrombosis and Haemostasis, researchers have found that by increasing the stability factor VIIIa using a disulfide bond, the factor can live in the blood longer. This discovery may prove useful in the design of future treatments for hemophilia.

Source: Proteomics Weekly.

(Courtesy of www.hemophilia.org)

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November 9th, 2003

NHF BOARD CHOOSES NEW OFFICERS

At its meeting on November 9 in Salt Lake City, the NHF Board of Directors voted to elect Jordan Lurie, MD president of the organization. Prior to the vote, Lurie was serving in the capacity of acting president and president elect. An anesthesiologist by profession, Lurie resides in Castle Rock, Colorado, with his family, including a son with hemophilia A. Lurie has previously served as the chair of the Advocacy and Communication committees of the NHF Board. He is a member of the Hemophilia Society of Colorado. For the full article, visit http://www.hemophilia.org/News/nhfnews/nn_11_09_03.htm.
New elections for the NHF Board will take place in March of 2004. For further information on NHF Board elections, contact Gary Widlund at gwidlund@hemophilia.org.
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November 7th, 2003

HOPPS Payment Cuts Overturned

The Centers for Medicare and Medicaid Services accepted the NHF's recommendation to keep the 2004 hospital outpatient prospective payment system rates for factor at the 2003 prices. They adopted the freeze because of poor quality of reported hospital cost data and the potentially negative impact of further reimbursement reduction. For the full story, go to: http://www.hemophilia.org/News/legislative/lu_11_07_03.htm

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On November 7th, the Inhibitors-Ports and Prophylaxis session during NHF’s 55th Annual Meeting in Salt Lake City will be presented live as an interactive webcast, allowing you to participate in the session from your home computer. Click here to register for the webcast: http://www.hemophilia.org/inhibitors/webcast/ . The session will feature a presentation by Dr. Amy Sapiro and Kathy Bosma, RN. As a webcast participant, you’ll be able to hear the audio portion of the session, view the presentation slides, ask questions, and receive real-time feedback from surveys. The webcast will take place on Friday, November 7th at 5pm-7pm ET. For questions or problems, please email NHF Web Development Manager, Shahzad Abbas at webmaster@hemophilia.org.

The session will also be the debut of the NHF Online Inhibitor Community, the first of many new NHF Online Communities that will launch over the next year and will together form an important part of a new, entirely redesigned hemophilia.org. More and more of the new site will start appearing over the next few months, but you can preview the NHF Online Inhibitor Community, which will officially launch on November 7th, thanks to the generous sponsorship of Novo Nordisk. So whether you are personally affected by inhibitors, or you just want to take a look at what’s coming for the entire community, log on to www.hemophilia.org/inhibitors today.


October 14, 2003

Genetic Discrimination Legislation Passed by Senate

After six years of efforts by bleeding disorders and other consumer organizations, the United States Senate passed vote the Genetic Information Nondiscrimination Act with a unanimous vote on October 14, 2003. To view the rest of the article, please visit http://www.hemophilia.org/News/legislative/lu_10_14_03.htm.


Annual Meeting Update:
Time is Running Out. Register Now or Refer Others for a Chance to Win Free Airfare!

If you haven’t yet signed up for NHF’s 55th Annual Meeting in Salt Lake City, you’re coming dangerously close to missing out on the largest, most comprehensive meeting for the bleeding disorders community. Registrations have been pouring in and space is running out. Visit http://www.hemophilia.org/events/utah/index.htm to register online today. More information here: http://www.hemophilia.org/News/nhgnews/nn_10_14_03.htm.


October 10, 2003

NHF to conduct Online Auction of Celebrity Blue Jeans

National Hemophilia Foundation has announced an upcoming fundraising event called “Blue Jeans for Genes”. The event consists of an online auction of beloved, autographed blue jeans donated by celebrities from the worlds of movies, music, television, sports, literature and politics. All winning bids benefit NHF. The auction will take place on November 10-19 on eBay: http://www.wbay.com/charity.



October 8, 2003

FDA Plans Workshop on Factor VIII Inhibitors

The Food and Drug Administration (FDA) has announced a workshop on factor VIII (FVIII) inhibitors scheduled to take place on November 21, 2003 in Bethesda, Maryland. For more information, go to http://www.hemophilia.org/News/legislative/lu_10_08_02.htm.


October 6, 2003

NHF Responds to Proposed Hospital Outpatient Payment Rates

The National Hemophilia Foundation (NHF) sent comments to the Centers for Medicare and Medicaid Services (CMS) on proposed 2004 Medicare payment reductions in hospital outpatient reimbursement for clotting factor. The August 12, 2003 Federal Register issued by CMS proposed 10% reductions in place of the reductions that would occur if CMS were to rely upon data provided by hospitals on clotting factor costs. The rest of the article is here: http://www.hemophilia.org/News/legislative/lu_10_06_03.htm.


September 22, 2003

New Study of Hemophilia Drug Begins

Octagen Corp. of Bala Cynwyd and Paris-based Beaufour Ipsen began human studies of a potential new hemophilia treatment earlier last month. The study marks the first phase-I clinical trial or Octagen, which was founded in 1997 to develop new therapies for hemophilia and other disorders related to the blood-clotting process. Please go to http://www.hemophilia.org/News/medicalnews/mm_09_22_03.htm for the rest of the information.




Other Items

PROJECT RED FLAG UPDATE

Back to the Hill—on September 9, NHF’s “Project Red Flag—Real Talk About Women’s Bleeding Disorders”, will host a second Congressional Tea Briefing, to be held in the Capitol Building. Volunteers from our D.C. area chapter, the Hemophilia Association of the Capital Area (HACA), have been busy personally delivering invitations to members of the House and Senate. The briefing will feature Project Red Flag Co-chairs, Drs. Paula Elbirt and Andra James, and Sally Crudder of the Centers for Disease Control and Prevention (CDC). Three women affected by bleeding disorders will also tell their personal stories. To attend, or for more information, please email Anna DeSimmone at adesimone@hemophilia.org or call 212.328.3705.


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Many Stories, One Voice- NHF’s 55th Annual Meeting Update

Meeting fever has set in at the New York office as registrations flow in. In the beautiful setting of Salt Lake City, Utah, the annual meeting working group ’03 has developed a top-notch program of education and events. More information is here: http://www.hemophilia.org/News/nhfnews/nn_08_29_03.htm


MEDICAL ADVISORIES:

NEW BAXTER LOT NUMBERING SYSTEM FOR ADVATE

October 17, 2003- The National Hemophilia Foundation recently was made aware of a discrepancy between the lot number on the carton of ADVATE rAHF-PRM and the lot number on the vial of ADVATE contained in the carton. The discrepancy exists in the last two digits of a 10-digit number. NHF was made aware of the discrepancy by several providers of clotting factor products and by Baxter BioScience, the manufacturer of ADVATE.

NHF contacted the U.S. Food and Drug Administration (FDA) to verify its approval of Baxter’s use of a 10-digit lot numbering system for ADVATE. FDA confirmed that the “lot number” is the first eight digits of the number. There should be no discrepancy between the carton and the vial in the first eight digits of the lot number.

The last two digits of the 10-digit number are an internal tracking mechanism developed by Baxter to further track filling and finishing times fro the ADVATE product. FDA confirmed that it is not unusual for a slight variation in these numbers to occur and that Baxter is not in violation of any FDA regulation regarding product labeling in its use of this system. The lot number discrepancy between the carton and the vial should not affect product quality.

NDF has expressed concern to Baxter and to the FDA regarding the confusion arising from the discrepancy in the numbers on the carton and the vial. Baxter has indication they are considering and alternative tracking mechanism to avoid confusion in the future.

Click here to read a “Dear Customer” letter distributed by Baxter regarding its lot numbering system for ADVATE. (If you are having trouble opening this file, click here to download Acrobat Reader.)

This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF, under no circumstances, recommends treatment for specific individuals and, in all cases, recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.
NHF MEDICAL ADVISORY #398

BAXTER ANNOUNCES EXPIRATION DATE CHANGE

RELATED TO RECOMBINATE® PRODUCTS

Baxter BioScience has announced a change in sterile water for injection (SWFI) manufacturers that affects the expiration dating on cartons of its RECOMBINATE® clotting factor products. Baxter began manufacturing its own SWFI, also known as diluent, in March 2003. Due to the change, the expiration date on the clotting factor concentrate vial and the date on the SWFI vial may differ, with the SWFI, at times, having an earlier expiration date. Consumers, however, should be aware that U.S. Food and Drug Administration regulations require the earliest expiration date of packaged items to appear on the outside carton. Thus, the expiration date on the carton may be that of the SWFI and not the RECOMBINATE® itself.

Because expired SWFI can develop bacterial or other contamination, consumers should not use bottles of expired sterile water. Users of RECOMBINATE® are encouraged to check the dating of the SWFI vial with the factor vial and the carton prior to infusion. Consumers in possession of expired vials of RECOMBINATE® is still good until expiration date on its vial.

This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.

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RECALL OF STERILE WATER PACKAGED WITH HUMATE-P
Aventis Behring L.L.C. is recalling seven lots of the Sterile Water for Injection packaged with Humate-P. The identified lots of Sterile Water for Injection were packaged for use as diluent with forty-five lots of Humate-P 1000 IU/2200 RCoF.
Aventis Behring has identified an incidence of cracked vials involving these lots of Sterile Water for Injection. As a precaution, the company is recalling these lots of Sterile Water for Injection only. The voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration. This action is not a recall of Humate-P. Click here for a list of the affected lots of Sterile Water for Injection and the associated lots of Humate-P.
Consumers are asked to check all product in their possession for the identified lot numbers and return affected bottles of Sterile Water for Injection to their product provider to receive replacement vials.

If you have any questions, please contact at Aventis Behring at (800) 683-1288 or the National Notification Group at (888)-UPDATE-U.
PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.
CHAPTERS: Please distribute this information to your membership.
Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The System is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge.
To enroll in the PNS, please call (888) UPDATE-U or go online at www.patientnotificationsystem.org.
This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.

 

The Vanderbilt Hemostasis-Thrombosis Clinic
397 Preston Research Building
Nashville, TN 37232-6310
(615) 936-1765

For more information about bleeding and clotting disorders, call toll-free 1-866-DR BLOOD
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