The FDA and Biogen today jointly issued a warning that Avonex can cause severe liver injury, including liver failure, when used in conjunction with other drugs that affect the liver.
"In post-marketing experience severe hepatic injury, including cases of hepatic failure,
has been reported rarely in patients taking AVONEX.
In some cases, these events have occurred in the presence of other drugs that have been
associated with hepatic injury. The potential for hepatic injury should be considered when
AVONEX is used in combination with other products associated with hepatic injury, or when
new agents are added to the regimen of patients already on AVONEX."
The company is revising the drug's label to include the new warning.
Two black eyes for BiogenIdec in two weeks... no eyes left for March, and we're only yet in the ides!
Click "read more" to get the advisory...
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FDA Advisory on Avonex
FDA and Biogen notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS/Drug Interactions and ADVERSE REACTIONS/Post-Marketing Experience sections and Medication Guide. Severe hepatic injury, including cases of hepatic failure, has been reported in patients taking Avonex. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge. In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury. The potential risk of Avonex used in combination with known hepatotoxic drugs or other products (e.g. alcohol) should be considered prior to Avonex administration, or when adding new agents to the regimen of patients already on Avonex.
Link to Letter
Revised Label
Note: This warning is similar to that of the other interferon drugs.
