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Sales of Tysabri stopped in United
States
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Summary
Biogen Idec and Elan Corporation announced February 28 they
have voluntarily withdrawn Tysabri® (natalizumab)
for sale in the United States and have stopped using it in
clinical trials. They have asked doctors to stop prescribing
the medication. The suspension follows disclosure of the
death of one person because of the development of a rare
but very serious central nervous system disease called progressive
multifocal leukoencephalopathy (PML). A second person is
suspected of having PML. Both people had received Tysabri
in combination with Avonex® (interferon
beta-1a) for more than two years in a clinical trial setting.
The companies, which are both involved in
the development and marketing of the medication, have said
they will work with clinical investigators to evaluate people
who have been treated with Tysabri and with medical experts
and government regulatory agencies to investigate the adverse
events. Biogen Idec Canada said it had already informed Health
Canada of the new developments.
Tysabri was approved by the US Food and
Drug Administration (FDA) on November 23, 2004. It is currently
under review by Health Canada for approval in Canada as a therapy
for multiple sclerosis.
Biogen Idec Canada has available an information
line in English and French for further inquiries about Tysabri
(natalizumab): 1-877-674-6365. For background information about
Tysabri please see the following Medical Update Memos:
ASK MS Information System Code: 1.4.1.12.2.r
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health
agency and does not approve, endorse or recommend any specific product or therapy
but provides information to assist individuals in making their own decisions.
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