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HFM acknowledges National Hemophilia Foundation (NHF) Baxter Heparin Recall (dated February 15, 2008) FDA Violation letter to PlasmaCare (dated October 22, 2007 ) Grifols Commitment to Quality and Safety (November 13, 2007) FDA Response to Warning Letter (dated November 20, 2007) PlasmaCare Response to Warning Letter (dated December 6, 2007)
MASAC Document #179 MASAC Recommendation Concerning Prophylaxis Administration of Clotting Factor Concentrate to Prevent Bleeding) The following recommendation was approved by the Medical and Scientific Advisory Council (MASAC) on November 3, 2007, and adopted by the NHF Board of Directors on November 4, 2007.
There are no clear cut guidelines as to when to stop prophylaxis. Joint bleeds with subsequent joint destruction are a lifelong problem for these individuals. (6) Therefore, they may continue to benefit from prophylaxis throughout their life. As always, a careful analysis of health risks and benefits must be performed by consumers and their health care providers. After a thorough discussion with their medical team, persons with hemophilia and their families should decide if prophylaxis is appropriate for them or their child. This decision should be evaluated periodically, particularly in light of emerging data and changes in bleeding and clotting factor usage. As is the case with all recommendations, MASAC will periodically reexamine this recommendation as new data emerge. References: 1. Brackman HH, Eickhoff HJ, Oldenburg J et al.: Long-term therapy and on-demand treatment of children and adolescents with severe hemophilia A: 12 years of experience. Haemost 1992; 22: 251-258. 2. Nilsson IM, Berntorp E, Löfqvist T, Petterson H.: Twenty-five years experience of prophylactic treatment in severe haemophilia A and B. J Intern Med 1992; 232: 25-32. 3. Petrini P, Lindvall N, Egberg N, Blombäck M: Prophylaxis with factor concentrates in preventing hemophilic arthropathy. Am J Pediat Hematol Oncol 1991; 12: 280-287. 4. Carlsson M, Berntrop E, Bjorkman S, Lindvall K: Pharmacokinetic dosing in prophylactic treatment of hemophilia A. Eur J Haematol 1993; 31: 247-252. 5. Manco-Johnson M, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med 2007; 357: 535-544. 6. Aledort LM, Haschmeyer RH, Pettersson H. A longitudinal study of orthopaedic outcomes for severe factor-VIII-deficient haemophiliacs. The Orthopaedic Outcome Study Group. J Intern Med 1994; 236: 391-399. 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 particular treatment for specific individuals and in all cases recommends that you consult your physician or local treatment center before pursuing any course of treatment. Copyright 2007 National Hemophilia Foundation. To facilitate the dissemination of these medical recommendations, reproduction of any material in this publication in whole or in part will be permitted provided: 1) a specific reference to the MASAC recommendation number and title is included and 2) the reproduction is not intended for use in connection with the marketing, sale or promotion of any product or service. NHF reserves the right to make the final determination of compliance with this policy. For questions or to obtain a copy of the most recent recommendations, please contact the NHF Director of Communications at 1-800-42-HANDI or visit the NHF website at www.hemophilia.org. NHF November 30, 2006
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.
February 18, 2005 FDA Issues Nationwide Alert for Preloaded SyringesThe Food and DrugAdministration 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.
FDA Issues Nationwide Alert on IV Flush Brand of Preloaded Syringes Containing Heparin or Sodium Chloride Intravenous Catheter FlushesFDA is issuing a nationwide alert against the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by the IV Flush, LLC and distributed by Pinnacle Medical Supply, of Rowlett, Texas, because these products have not received proper clearance from FDA and may be contaminated. Consumers and institutions who have these preloaded syringes containing heparin or sodium chloride intravenous flushes should return them to the IV Flush, LLC or the original distributor. The firm voluntarily recalled the products because they lacked proper FDA clearance for marketing. FDA and the company have also been informed of P seudomonas fluorescens (P. fluorescens) infections in patients possibly caused by the heparin flushes . These cases are continuing to be investigated. The heparin and sodium chloride containing intravenous flushes were sold to distributors who redistributed to other medical distributors and hospitals. They can be identified by the syringe label, which reads in part: "IV Flush Dallas, TX." IV Flush, LLC, is notifying its distributors by phone and letter and has requested those distributors contact their customers. The company is arranging for return of all recalled products. P. fluorescens is an infrequent cause of infection, but has been reported to cause outbreaks of pseudobacteremia, i.e., presence in a blood culture in the absence of clinical evidence of bloodstream infection. P. fluorescens has also been reported as the cause of procedure-related infections and infections resulting from transfusion with contaminated blood components. Consumers with questions may contact the company at 1-972-463-7389. Persons wanting to report anything to the Food and Drug Administration regarding either of these products may contact FDA's MedWatch office at 1 800-FDA-1088. NHF December 7, 2004, Medical Advisory # 402Beige Substance" Formation on Certain Butterfly NeedlesThe 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. vCJD RISK ANNOUNCED FOR U.K. PLASMA PRODUCTSOn 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 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 Abbott Butterfly Needle AdvisoryA 23 gauge Abbott butterfly needle has been returned to their provider that had beige colored ‘crust’ at the end of the needle. The item number on the plastic package is No. 4565 and the lot number which is embossed in the plastic is 14064R5. Abbott has been notified and they indicated that they have had similar complaints about other lots, but say their investigation may take one to three months. We recommend the following:
See the picture below of one of the needles in question:
December 19, 2003 Biological Recall of Immune Blobulin Intravenous (Human)Aventis Behring LLC
Dear Colleague:
This recall is to the pharmacy level. Please read the full recall letter.
Sincerely, NHF November 6, 2003, Medical Advisory # 400 Recall of Sterile Water Package with Humate-PAventis 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. 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. NHF October 17, 2003, Medical Advisory # 399New Baxter Lot Numbering System for AdvateThe 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 for 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. NHF 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 indicated they are considering an 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. NHF August 11, 2003 Medical Advisory # 398 August 8, 2003- 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 SWFI should contact their product provider for replacement vials of sterile water. The RECOMBINATE® is still good until expiration date on its vial.
NHF Medical Advisory archive is available at NHF News Medical Advisories  MASAC Documents approved by the NHF Board on October 14, 2006: Document #171  
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