Avonex, Interferon beta-1a, is approved for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations.

FDA and Biogen informed healthcare professionals about revisions to the Avonex labeling.

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.

Source: FDA, 2005


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