Performance Improvement 2000. Biologics Evaluation

01/01/2000

Interferon Beta-1b Injection Site Reactions and Necroses

The article entitled, "Interferon beta-1b injection Site Reactions and Necroses," appearing in Multiple Sclerosis in May of 1998, explores the safety of Betaseron (interferon beta-1b). Beta interferon was first licensed for injection treatment of multiple sclerosis in 1993. It has generated the largest number of adverse event reports received by the Food and Drug Administration (FDA), with 8,300 reports received between 1995 and 1996. This represented the largest summary of adverse event data for a biological therapeutic product ever compiled at the agency. The findings in the report led to changes in product labeling, thereby reducing the risk of severe site reactions and necroses in multiple sclerosis patients.

AGENCY SPONSOR: Food and Drug Administration

FEDERAL CONTACT: Gaines, Ann
301-827-3974

PIC ID: 7093

PERFORMER: Food and Drug Administration
Rockville MD