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FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol
Today, the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) held a meeting to discuss the risk /benefit profile of Trasylol® (aprotinin injection), a Bayer drug used in coronary artery bypass graft (CABG) surgery. At the close of the meeting, based on the Trasylol data in Bayer’s controlled clinical studies and after considering data from observational studies and public testimony presented at the meeting, the Committees recommended that US marketing authorization for Trasylol should be continued. The Committees also recommended that Bayer amend the U.S. product label for Trasylol to provide additional prescribing guidance to physicians and also recommended that Bayer conduct additional clinical studies, including randomized controlled trials, to further assess the risk and benefit of Trasylol. For more information, please visit: http://viva.vita.bayerhealthcare.com/index.php?id=36&tx_ttnews[tt_news]=12033
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Fentora (fentanyl buccal tablet) and the occurrence of serious adverse events
Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora. Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Serious adverse events, including deaths, have occurred in patients treated with Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of Fentora to reduce the risk of respiratory depression. Read the complete MedWatch 2007 Safety Summary including a link to the Dear Doctor and Dear Healthcare Professional Letters and Prescribing information, at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113690.htm
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