Guest guest Posted June 7, 2007 Report Share Posted June 7, 2007 Viracept is manufactured by Roche overseas and by Pfizer in the USA. In a message dated 6/7/07 6:15:40 PM, fiar@... writes: Check it if you're on it--if it smells funny, stop using it. Of course, this isn't happening in the United States. How do we know? Roche says so! And of course, these companies would never ever lie! M. *** http://www.eatg.org/news/newsitem.php?id=1856 Roche recalls Viracept due to chemical impurity Wednesday, June 06, 2007 Patients are requested to contact their doctors to discuss alternative therapies. Roche, in agreement and cooperation with Health Authorities (EMEA and Swissmedic), recalls in Europe and some other world regions all batches of Viracept powder and tablets. The US, Canada and Japan are not affected by this recall. *** http://www.eatg.org/news/newsitem.php?id=1858 European Medicines Agency announces recall of Viracept Wednesday, June 06, 2007 The European Medicines Agency has been made aware in the evening of 5 June 2007 by Roche Registration Limited of a contamination with a harmful substance affecting the production of Viracept. The European Medicines Agency has been made aware in the evening of 5 June 2007 by Roche Registration Limited of a contamination with a harmful substance affecting the production of Viracept (nelfinavir), an antiretroviral medicine used to treat HIV-1 infected adults, adolescents and children of 3 years of age and older. As a consequence, the product is being recalled from the European Union markets, with immediate effect. Roche has identified the presence of an unexpected contaminant ethyl mesylat (also known as methane sulfonic acid ethylester) in some batches of Viracept. Ethyl mesylate is a known genotoxic substance (harmful to DNA). The level of risk to patients resulting from this contamination is difficult to measure, and is currently under further evaluation. .... ************************************** See what's free at http://www.aol.com. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 7, 2007 Report Share Posted June 7, 2007 Viracept is manufactured by Roche overseas and by Pfizer in the USA. In a message dated 6/7/07 6:15:40 PM, fiar@... writes: Check it if you're on it--if it smells funny, stop using it. Of course, this isn't happening in the United States. How do we know? Roche says so! And of course, these companies would never ever lie! M. *** http://www.eatg.org/news/newsitem.php?id=1856 Roche recalls Viracept due to chemical impurity Wednesday, June 06, 2007 Patients are requested to contact their doctors to discuss alternative therapies. Roche, in agreement and cooperation with Health Authorities (EMEA and Swissmedic), recalls in Europe and some other world regions all batches of Viracept powder and tablets. The US, Canada and Japan are not affected by this recall. *** http://www.eatg.org/news/newsitem.php?id=1858 European Medicines Agency announces recall of Viracept Wednesday, June 06, 2007 The European Medicines Agency has been made aware in the evening of 5 June 2007 by Roche Registration Limited of a contamination with a harmful substance affecting the production of Viracept. The European Medicines Agency has been made aware in the evening of 5 June 2007 by Roche Registration Limited of a contamination with a harmful substance affecting the production of Viracept (nelfinavir), an antiretroviral medicine used to treat HIV-1 infected adults, adolescents and children of 3 years of age and older. As a consequence, the product is being recalled from the European Union markets, with immediate effect. Roche has identified the presence of an unexpected contaminant ethyl mesylat (also known as methane sulfonic acid ethylester) in some batches of Viracept. Ethyl mesylate is a known genotoxic substance (harmful to DNA). The level of risk to patients resulting from this contamination is difficult to measure, and is currently under further evaluation. .... ************************************** See what's free at http://www.aol.com. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 7, 2007 Report Share Posted June 7, 2007 Viracept is manufactured by Roche overseas and by Pfizer in the USA. In a message dated 6/7/07 6:15:40 PM, fiar@... writes: Check it if you're on it--if it smells funny, stop using it. Of course, this isn't happening in the United States. How do we know? Roche says so! And of course, these companies would never ever lie! M. *** http://www.eatg.org/news/newsitem.php?id=1856 Roche recalls Viracept due to chemical impurity Wednesday, June 06, 2007 Patients are requested to contact their doctors to discuss alternative therapies. Roche, in agreement and cooperation with Health Authorities (EMEA and Swissmedic), recalls in Europe and some other world regions all batches of Viracept powder and tablets. The US, Canada and Japan are not affected by this recall. *** http://www.eatg.org/news/newsitem.php?id=1858 European Medicines Agency announces recall of Viracept Wednesday, June 06, 2007 The European Medicines Agency has been made aware in the evening of 5 June 2007 by Roche Registration Limited of a contamination with a harmful substance affecting the production of Viracept. The European Medicines Agency has been made aware in the evening of 5 June 2007 by Roche Registration Limited of a contamination with a harmful substance affecting the production of Viracept (nelfinavir), an antiretroviral medicine used to treat HIV-1 infected adults, adolescents and children of 3 years of age and older. As a consequence, the product is being recalled from the European Union markets, with immediate effect. Roche has identified the presence of an unexpected contaminant ethyl mesylat (also known as methane sulfonic acid ethylester) in some batches of Viracept. Ethyl mesylate is a known genotoxic substance (harmful to DNA). The level of risk to patients resulting from this contamination is difficult to measure, and is currently under further evaluation. .... ************************************** See what's free at http://www.aol.com. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 11, 2007 Report Share Posted June 11, 2007 Dear members, Those of you connected with ART, please see this link sent by Dr. Po-Lin Chan (Country Officer HIV/AIDS, WHO India) containing information regarding recall of Roche's Viracept (Nelfinavir) due to contamination of some of the batches. WHO STATEMENT ON ROCHE'S VIRACEPT® RECALL ROCHE have informed WHO today (08 June 2007) of the global recall their nelfinavir products (Viracept®) in accordance with European Medicines Agency (EMEA) and Swissmedic requirements (except USA, Canada and Japan). The reason for the recall is identification of an unexpected contaminant in some batches of Viracept®. The contaminant is a known genotoxic substance. For further information, please see the EMEA statement at: http://www.emea.europa.eu/pdfs/general/direct/pr/25128307en.pdf . Current stocks of Viracept® should be quarantined. Adults or children currently taking Viracept® should not interrupt their therapy, that is they should not stop any of the antiretroviral (ARV) medications. However, they should see their antiretroviral therapy provider as soon as possible to change from Viracept® to a suitable alternative. Nelfinavir belongs to the Protease Inhibitor (PI) class of antiretroviral medicines. The PI class should be reserved for second-line therapy wherever possible, particularly in settings of limited ARV formularies. In choosing the PI for second-line therapy for adults and children a PI boosted by ritonavir (/r) is recommended for antiviral potency. Adequate within-class substitutions for Viracept® are any of the following protease inhibitors - Lopinavir/ritonavir (LPV/r), Indinavir/ritonavir (IDV/r), Saquinavir/ritonavir (SQV/r), Atazanavir/ritonavir (ATV/r), and Fosamprenavir/ritonavir (FPV/r). LPV/r is the preferred boosted PI, as it has the advantage of being available as a fixed dose combination and has recently been approved in a new heat stable formulation, which eliminates the need for refrigeration. In children, SQV is only licensed for use in children over 25kg and ATV and FPV are not yet approved for use. Nelfinavir may exceptionally be being used as part of initial therapy for pregnant women. If it is the case and no other PI is available, then substitution of Viracept® by another active ARV from another class of drugs will need to be considered. Non-nucleoside reverse transcriptase inhibitors drugs need to be used with caution in pregnant women. Nevirapine may be associated with toxicity in women with CD4 counts above 250 cells/mm3. Efavirenz should be avoided in the 1st trimester of pregnancy because of potential for birth defects and in children less than 3 years of age. Abacavir as part of a triple nucleoside regimen may also be considered. In summary for patients needing to substitute Viracept®, options include: • a boosted protease inhibitor; • Nevirapine - with close observation for toxicity if CD4 is above 250 cells/mm3 : • Efavirenz - unless in the first trimester of pregnancy; • triple nucleoside therapy. For further details of current treatment recommendations, please refer to the following web link: http://www.who.int/entity/hiv/pub/guidelines/en . http://www.who.int/prequal/info_press/ViraceptRecall-WHONote.pdf Kindly inform all people concerned. Regards, Dr.Nabeel.M.K. e-mail: <drnabeelmk@...> Quote Link to comment Share on other sites More sharing options...
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