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FDA Public Health Advisory
AVONEX WARNING ISSUED
Biogen Idec and U.S. regulatory officials have issued a warning to
doctors stating that Avonex can cause liver damage and liver failure. The
warning, which is in a letter posted on the Food and Drug Administration's (FDA)
website, says, "In post-marketing experience, severe hepatic injury, including
cases of hepatic failure, has been reported rarely in patients taking Avonex."
Revisions to the warnings, adverse reactions, and post-marketing experience
sections of a medication are not unusual. According to Amy Ryan, a spokeswoman
from Biogen, this warning is "an ordinary change made to the drug's packaging."
Biogen Idec noticed an increased incidence of liver injury and liver failure and
initiated talks with the FDA about modifying its prescribing guide "a few months
ago." According to Ryan, the interest in liver complications is a current
concern of the FDA.
To learn more, visit
http://www.fda.gov/medwatch |
