Biogen Inc.’s Avonex
multiple sclerosis treatment now carries additional warnings about
worsening psychiatric symptoms and allergic reactions in some
patients, U.S. regulators said.
The Food and Drug Administration sent the announcement as
part of its MedWatch program, used to keep doctors and patients
aware of new complications found with drugs. The FDA also posted
on its Web site a letter that Biogen sent to doctors on March 7,
advising them of the changes to the label.
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Last month, Biogen said it would be sending doctors a letter
to notify them of rare cases in which patients taking Avonex
developed blood disorders and allergic reactions. The drug had
more than $1 billion in 2002 sales, Biogen said in January.
Biogen competes with Serono SA for sales of multiple
sclerosis drugs.
Bloomberg News
