FDA MedWatch - Betaseron (interferon beta-1b) hepatoxicity

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Berlex, Inc. reminded healthcare professionals of the prescribing information for Betaseron (interferon beta-1b) as it pertains to hepatic toxicity. Betaseron is approved for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. There have been reports during post-marketing safety surveillance of serious hepatic injury including autoimmune hepatitis and severe liver damage leading to hepatic failure and transplant. Liver function testing is recommended at regular intervals (one, three, and six months) following introduction to Betaseron therapy, and then periodically thereafter in the absence of clinical symptoms.

Read the complete FDA MedWatch 2005 Safety Summary, including a link to the Dear Healthcare Professional letter, at: