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From: TSS (216-119-144-12.ipset24.wt.net)
In Reply to: blood products? posted by sarah m on August 7, 2004 at 1:26 pm:
WARNINGS RhoGAM® and MICRhoGAM® are made from human plasma. Because these products are made from human blood, they may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections and by removing certain viruses during the manufacturing process. Following fractionation, an additional viral-clearance filtration step is incorporated into the manufacturing process. This filtration step removes viruses via a size-exclusion mechanism utilizing a patented Viresolve 180 ultrafiltration membrane with a defined pore-size distribution of 12-18 nanometers. The filter is inert to the product. This virus removal process has been shown in laboratory spiking studies to reduce the levels of some viruses ranging from 18-200 nanometers in size, including enveloped viruses as well as non-enveloped viruses. 4 All of the above steps are designed to increase product safety by reducing the risk of transmission of lipid-enveloped and non-lipid-enveloped viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by these products should be reported by the physician or other healthcare provider in the United States to Ortho-Clinical Diagnostics, Inc. at 1-800-421-3311. Outside the United States, the company distributing these products should be contacted. The physician should discuss the risks and benefits of these products with the patient. RhoGAM and MICRhoGAM are manufactured and distributed by Ortho-Clinical Diagnostics, Inc., Raritan, NJ 08869. recalls below; http://www.fda.gov/cber/recallsmore.htm the 2 sites below have not been updated since the new findings have been Guidance for Industry Guidance for Industry http://www.fda.gov/cber/gdlns/cjdvcjdq&a.htm CJD Agent Removal Claims For Plasma Products Should Be Considered by FDA, Cmte. Says Labeling claims concerning the removal of Creutzfeldt-Jakob disease agents from plasma-derived products should be considered by FDA, FDA’s Transmissible Spongiform Encephalopathies Advisory Committee concluded Feb. 20. The committee voted affirmatively, in a 12-to-one vote, to an agency question that asked: "Assuming adequacy of decontamination procedures in product manufacturing, should FDA consider labeling claims for TSE clearance in plasma derivatives, based upon specific demonstration of TSE removal during manufacturing?" FDA has been approached by manufacturers who would like to modify the current warning statement in plasma products that reads: "Because [this product] is made from human blood, it carries a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent." In order to obtain a claim, FDA said that companies would have to submit individual data demonstrating reduction of TSE agents through a validated process, similar to that used in removal of viruses from plasma products. The method would entail the use of a scaled-down manufacturing process that produces the product, spiking the product with a TSE agent (derived from hamster brain homogenate, purified scrapie prion protein, etc.) and then demonstrating clearance through precipitation or another method, and measuring the log10 difference in TSE agent before and after removal. While the committee felt that companies should be allowed to pursue a reduced risk claim with regards to TSE agents, a general claim being proposed by FDA should not represent the final labeling language, committee members concurred. The general claim proposed by FDA states: "Because this product is made from human plasma, it carries the risk of transmitting infectious agents, e.g. viruses, and theoretically, the CJD agent. It has been demonstrated that [the manufacturer]’s manufacturing process provides substantial clearance of agents similar to those causing CJD and [variant]CJD. Thus the theoretical risk of transmission of CJD or vCJD is considered extremely remote." Many committee members said the language on viruses, which are of known risk, and the language on CJD agents should be separated in the warning. Some members also felt that, rather than general language, the claim should contain specific information on the product and the degree of TSE agent removal. Several committee members said that a one log10 reduction in TSE agent would not be considered a significant clearance and urged FDA to require at least three to four log10 reductions. Members of the Plasma Protein Therapeutics Association – which include Aventis, Baxter and Bayer – have demonstrated reductions in TSE agents in preliminary studies for various products. Those studies achieved 4-8 log reductions in Factor VIII products, 3-8 log reductions in immunoglobulin products and 6-16 log reductions in albumin products. To watch a live or archived webcast of this meeting, click the button below. To arrange for live videoconferencing or to order videotapes & CDs, email webcasthelp@elsevier.com or call 800-627-8171. [PPT] Consideration of Labeling Claims for TSE Agent Clearance in Plasma ... http://www.fda.gov/ohrms/dockets/ac/03/slides/3923S1_08.ppt&e=912 TSS
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