Premiere issue of FDA Drug Safety Newsletter released.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Sept. 18 issued the first edition of its new "Drug Safety Newsletter." The newsletter, to be published online quarterly, has findings of selected post-marketing drug safety reviews from FDA's Center for Drugs and provides information on important emerging drug safety issues and recently approved new molecular entities and new drugs. The newsletter is intended to complement other FDA methods of communicating drug safety information to the public. FDA also hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals. This first issue includes post-marketing reviews of Rituxan (rituximab) and the risk of Progressive Multifocal Leukoencephalopathy Progressive Multifocal Leukoencephalopathy Definition Progressive multifocal leukoencephalopathy (PML) is a rapidly progressive neuromuscular disease caused by opportunistic infection of brain cells (oligodendrocytes and astrocytes) by the JC virus (PML PML - Parallel ML. ["Synchronous Operations as First-Class Values", J.H. Reppy <jhr@research.att.com>, Proc SIGPLAN 88 Conf Prog Lang Design and Impl, June 1988, pp. 250-259]. ); Provigil (modafinil) and its potential for serious skin reactions; Temodar (temozolomide) in regard to risk of aplastic anemia aplastic anemia or anemia of bone-marrow failure Inadequate blood-cell formation by bone marrow. Pancytopenia is the lack of all blood-cell types (erythrocytes, leukocytes, and platelets), but any combination may be missing. . It also includes early safety findings on the New Molecular Entity (NME NME Name NME Enemy NME New Musical Express NME Neisseria Meningitidis NME New Molecular Entities (US FDA New Drug Approval reports) NME Network Management Ethernet NME New Music Express ) Exjade (deferasirox.) The publication of this newsletter fulfills a commitment FDA made in its January 2007 Response to the Institute of Medicine's (IOM IOM See: Index and Option Market ) 2006 Report, "The Future of Drug Safety--Promoting and Protecting the Health of the Public." The agency's response to the IOM report can be found at: http://www.fda.gov/oc/reports/iom013007.html The newsletter will be sent electronically to those who subscribe to the Drug Safety Newsletter or to the MedWatch E-list. A fact sheet and the inaugural issue of the newsletter can be found at: http://www.fda.gov/cder/dsn/default.htm <http://www.fda.gov/cder/dsn/default.htm>. |
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