Update on Tysabri®

October 2008
PN;Oct2008, Vol. 62 Issue 10, p40
Trade Publication
The article reports on the information from the U.S. Food and Drug Administration (FDA) on the 2 cases of multimodal leukoencephalopathy (PML) in people who were taking Tysabri as an immunotherapy. Tysabri is a monocloal antibody designed to control movement of potentially damaging immune cells. It states that the manufacturers Biogen Idec Inc. and Elan Pharmaceuticals Inc., held a conference detailing on the case, and reported no confirmed case of PML in people using the drug as monotherapy.


Related Articles

  • MS Drug Back on Market Under Restricted Program.  // FDA Consumer;Jul/Aug2006, Vol. 40 Issue 4, p7 

    The article reports on an application to resume the marketing of Tysabri (natalizumab) approved by the U.S. Food and Drug Administration (FDA) under a special restricted distribution program. Tysabri is a drug used to treat people with relapsing forms of multiple sclerosis to reduce the...

  • New Treatment for Multiple Sclerosis.  // FDA Consumer;Jan/Feb2005, Vol. 39 Issue 1, p6 

    Reports on a license given by the U.S. Food and Drug Authority to the Tysabri monoclonal antibody manufactured by Biogen Idec Inc. in 2004. Use of the drug in treating multiple sclerosis; Administration of the drug; Information on monoclonal antibodies; Function of Tysabri; Results of a...

  • The comeback kid: TYSABRI now FDA approved for Crohn disease. Honey, Karen // Journal of Clinical Investigation;Mar2008, Vol. 118 Issue 3, p825 

    The article reports on the approval of the U.S. Food and Drug Administration (FDA) for the use of monoclonal antibody TYSABRI in the treatment of adults with moderately to severely active Crohn disease (CD). According to the author, the approval represents a comeback of drugs that was pulled by...

  • Doctors, consumers and adverse reactions. Levin, Arthur Aaron // HealthFacts;Aug94, Vol. 19 Issue 183, p2 

    Reports on the reports generated by medWatch, a new Food and Drug Administration (FDA) program to encourage doctors to voluntarily report adverse effects caused by drugs and devices. Effects defined as serious; Monitoring of drugs and devices after approval as the weakest link in FDA's oversight...

  • FDA scraps adverse event definition. J. G. D. // Medical Marketing & Media;Nov2010, Vol. 45 Issue 11, p30 

    The article reports on the decision of the U.S. Food and Drug Administration (FDA) to abadon its proposed definition for a suspected adverse drug reaction (SADR).

  • FDA field targets ADR submissions. James G., Dickinson // Medical Marketing & Media;Oct97, Vol. 32 Issue 10, p30 

    Reports on the US Food and Drug Administration field compliance program for drug firms with a history of adverse drug reaction reporting problems. Examination of completion and accuracy of ADR submissions; Internet address of the compliance program.

  • Making a difference.  // Nature Biotechnology;Apr2009, Vol. 27 Issue 4, p297 

    This editorial states that officials at the U.S. Food and Drug Administration (FDA) should focus on producing a comprehensive database that provides information on adverse events and effects associated with various drugs. Beneath the administration of U.S. President Barack Obama, the FDA is led...

  • FDA expands adverse veterinary drug reports.  // DVM: The Newsmagazine of Veterinary Medicine;Sep2011, Vol. 42 Issue 9, p36 

    The article reports that the U.S. Food and Drug Administration (FDA) has been planning to list more information in its adverse drug experience (ADE) reports

  • R.Ph.s play critical role in reporting ADRs under new plan. Chi, Judy // Drug Topics;5/1/2000, Vol. 144 Issue 9, p23 

    Criticizes the United States Food and Drug Administration for its delay in notifying health professionals on adverse drug reactions (ADRs) of approved drugs. Proposal of a proactive data gathering approach on drugs ADRs reporting; Contributors of the proposal.


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics