Medical Advisory

Previous Advisories

Medical Advisory #406
November 29, 2006

FDA Confirms Low Risk for Creutzfeldt-Jakob Disease Among Persons Using Plasma-Derived Factor VIII Products Licensed in the US

On Monday, November 27th, the Food and Drug Administration (FDA) released documents relating to the Agency’s assessment of the risk of acquiring variant Creutzfeld-Jakob Disease (vCJD), a human form of “Mad Cow Disease, for persons with bleeding disorders who have used US licensed plasma-derived factor VIII products (pdFVIII). Although there are still too many uncertainties to allow the Agency to make a precise calculation of theoretical risk without further study of this issue, FDA officials and other experts continue to believe that this risk is exceedingly low but possibly not zero. It is important to note that there have been no known cases of vCJD in users of pdFVIII products worldwide, including in the United Kingdom where the prevalence of vCJD in the general population is the highest in the world.

On December 15, the agency will convene a panel of consumers, medical professionals and other experts to advise them on how best to broadly communicate this information to the public. NHF will participate on the panel, and will continue to work closely with the FDA and other government agencies to ensure that the community receives complete, accurate and timely information on this subject.

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia. The CDC will convene a call for HTC Directors on Friday – more information to follow.

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 go online at http://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 recommend that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.

Medical Advisory #405
June 09, 2006

Novo Nordisk Issues Missing Product Alert

The National Hemophilia Foundation has been notified of an alert issued by Novo Nordisk regarding a shipment of NovoSeven Coagulation Factor VIIa (Recombinant) that is missing from a storage facility. The specific product and lot number are included in this release from Novo Nordisk along with contact information in the event that you do encounter the lot number specified. At this time, there is no indication that this material entered any distribution channel. As advised by the company, this lot of product should NOT be used under any circumstances.

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.

CHAPTERS: Please distribute this information to your membership.

To enroll in the PNS, please go online at http://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.

Medical Advisory #404
February 18, 2006

FDA Issues Nationwide Alert for Preloaded Syringes

The Food and Drug Administration has issued a nationwide alert against the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by IV Flush, LLC because new cases of infection associated with use of these possibly contaminated products have been reported.

FDA announced that IV Flush had initiated a voluntary recall of the syringes on January 31, 2005 when FDA determined that the syringes lacked proper FDA clearance for marketing. FDA had been informed of a cluster of Pseudomonas fluorescens (P. fluorescens) infections in patients associated with heparin flushes. New reports of infections have led to this second notice. FDA is continuing to investigate the matter.

The syringes are distributed by Pinnacle Medical Supply and can be identified by the marking “IV Flush, Dallas, Texas.” IV Flush is arranging for the return of all recalled products and is in the process of notifying medical distributors and hospitals. Some of the intravenous flushes may have been provided to patients for home use.

The Centers for Disease Control and Prevention reported to the Medical and Scientific Advisory Council of the National Hemophilia Foundation that as of January 2005, no increase in intravenous catheter infections has been reported among individuals with hemophilia (MASAC, February 12, 2005). Nonetheless, the National Hemophilia Foundation urges persons with bleeding disorders in possession of IV flush syringes to inspect the syringes for the “IV Flush, Dallas, Texas” markings. If you have any of these syringes, discontinue use and contact your physician or hemophilia treatment center immediately. FDA has instructed clinicians with patients possibly infected from these products to report cases to their state or local health department, and the FDA. Additionally, anyone with questions can contact IV Flush directly at 1-972-463-7389 or the FDA's MedWatch office at 1 800-FDA-1088.

The February 4, 2005 FDA press release is available at: http://www.fda.gov/bbs/topics/news/2005/NEW01154.html

Medical Advisory # 403
January 18, 2005

vCJD RISK ANNOUNCED FOR GERMAN AND ITALIAN USERS FOR ZLB PRODUCT

The National Hemophilia Foundation (NHF) has been notified by ZLB Behring that a single lot of hemophilia clotting factor manufactured in 1996 by its predecessor company, Centeon, has been linked to a French donor who later developed variant Creutzfeldt-Jakob Disease (vCJD). The implicated lot (number 5676641) was marketed and sold under the brand name Haemate® HS 1000 in Germany and Haemate® P 1000 in Italy. According to ZLB, the lot was recalled in 1997 for reasons not related to the incidence of vCJD, but a majority of the lot was not returned. ZLB made the discovery during a self-initiated look-back following the announcement regarding the French donor.

ZLB’s U.S. product, Humate P®, is manufactured exclusively from U.S. donor plasma and, according to ZLB, is not affected by this announcement. To date, no cases of vCJD are known to have been transmitted by any plasma product. However, anyone who suspects they may have used product with the lot number above, anyone who lived in Germany or Italy in the late 1990’s and used Haemate® HS 1000 or Haemate® P 1000, and anyone who imported either of these products into the United States for compassionate or personal use should contact their hemophilia treatment center.

NHF continues to investigate all instances of plasma donations from donors later determined to have vCJD. While the potential for vCJD transmission through plasma products and derivatives is presumed to be low, the U.S. Food and Drug Administration (FDA) has not approved any manufacturing claim that the production process for any plasma-based coagulation product eliminates the risk of vCJD transmission. NHF will continue to disseminate updated and new information as it becomes available.

Medical Advisory # 402
December 7, 2004

"Beige Substance" Formation on Certain Butterfly Needles

The National Hemophilia Foundation has been contacted by several hemophilia treatment centers (HTCs) regarding a "beige substance" on the tip of butterfly needles distributed by a former Abbott division now an independent company called Hospira. Hospira has stated that the substance is a silicone coating that did not properly dry on the needle and that the substance is safe. There are no plans by Hospira at this time to recall the needles. No adverse events have been reported as a result of use of the needles.

At the request of NHF and several HTCs, the Food and Drug Administration (FDA) is conducting an investigation of this matter. A request also has been made to Hospira for the lot numbers of the implicated needles.

While FDA action on this issue is pending, NHF encourages all persons in the bleeding disorders community to carefully inspect needles, syringes and all other supplies used as part of the infusion procedure. Anyone who finds a substance on a needle is encouraged to safely dispose of the needle and to seek additional supplies if needed from his/her clotting factor provider.

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.

CHAPTERS: Please distribute this information to your membership.

Medical Advisory # 401
September 27, 2004

vCJD RISK ANNOUNCED FOR U.K. PLASMA PRODUCTS

On September 21, 2004, United Kingdom (UK) health authorities informed people with hemophilia and other bleeding disorders that they are considered "at risk" for variant Creutzfeldt-Jakob Disease (vCJD) if they used UK plasma products manufactured between 1980 and 1998. These products were made from plasma collected from donors in the UK who were later identified to have vCJD or possibly from donors who still remain asymptomatic for vCJD.

The UK's products were manufactured by Bio Products Laboratory and Protein Fractionation Centre, Scotland. These companies were not licensed by the US Food and Drug Administration (FDA) to distribute products in the United States, but UK plasma products, particularly factor XI, may have been brought into the US for use in clinical trials or for compassionate or personal use. FDA has not approved any manufacturing claim that the production process for any plasma-based coagulation product eliminates the risk of vCJD transmission. However, to date, no cases of vCJD are known to have been transmitted by any plasma product. The UK health authorities have said their actions are "precautionary" and "the actual risk to individuals is very low."

NHF is seeking to determine if any US clinical studies utilized UK plasma products. Anyone who suspects they may have used a UK plasma product between 1980 and 2001 or anyone who lived in or visited the UK during 1980 to 2001 and used UK plasma products during that time should contact their hemophilia treatment center. (The last year that the UK implicated product was produced was 1998, but the risk extends to the 2001 expiration date for these products.) UK plasma products manufactured after 1998 did not use plasma collected from UK donors.

The NHF will disseminate updated information concerning this issue as it becomes available. Additional information can be found through the following sites:

World Federation of Hemophilia -
http://www.wfh.org/ShowDoc.asp?Rubrique=30&Document=37

Canadian Hemophilia Society -
http://www.hemophilia.ca/en/index.html

U.K. Haemophilia Society –
http://www.haemophilia.org.uk/news.php?id=16

To enroll in the PNS, please call (888) UPDATE-U or go online at
http://gomembers-ecommunicator.com/ct/sdqj1Up1_1Nv/Patient-Notification-System.

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.

Other Important Information

MASAC Issues Important Recommendations for Patients and Providers
Urges Vigilance on Cox-2 Inhibitors, vCJD

Following a meeting at NHF's Annual Meeting in Dallas, NHF's Medical and Scientific Advisory Council (MASAC) released two recommendations and one resolution. In light of the recent voluntary recall of the arthritis drug VIOXX after it was found to lead to a greater frequency of heart attacks and strokes, MASAC's most anticipated recommendation concerned the use of COX-2 inhibitors (of which VIOXX is one) in people with bleeding disorders. "Providers should maintain close vigilance for symptoms and signs of heart attack, stroke, or gastrointestinal bleeding and should discuss these risks with their patients and suggest alternative analgesics," says the recommendation. "Monitoring of cardiovascular symptoms, as well as hemoglobin, hematocrit, and hemoccult testing, are encouraged."

The two other documents passed concern thrombogenicity of bypassing agents for management of hemophilia complicated by inhibitors and exposure to blood product derivatives and potential risk of vCJD.

Click here to read all MASAC Recommendations.

MASAC Issues Important Recommendations for Patients and Providers Urges Vigilance on Cox-2 Inhibitors, vCJD

MASAC Issues Important Recommendations for Patients and Providers
Urges Vigilance on Cox-2 Inhibitors, vCJD