Berlex, according to FDA ( Food and Drug Administration ), informed “ HealthCare Professional “ about the safety profile of Interferon beta-1b ( Betaseron ).

Since market introduction in 1993, the Betaseron prescribing information has recommended liver function testing at regular intervals ( one, three, and six months ) following introduction to Betaseron therapy, and then periodically thereafter in the absence of clinical symptoms.

Hepatotoxicity has been a reported adverse reaction to all beta-interferons.

There have been rare reports of serious hepatic injury including autoimmune hepatitis and severe liver damage leading to hepatic failure and transplant.
These events were reported during post-marketing safety surveillance.

In some cases, the hepatotoxic events reported for patients on beta-Interferons have occurred in the presence of other drugs and/or co-morbidity associated with hepatic injury.

Source: FDA, 2005


XagenaMedicine2005