FDA revises interferon beta-1a, drotrecogin alfa (activated) labels
The FDA and Biogen have notified health care professionals of revisions to the warnings, precautions/drug interactions, and adverse reactions/post-marketing experience sections and medication guide of interferon beta-1a (Avonex). Severe hepatic injury, including cases of hepatic failure, has been reported in patients taking interferon beta-1a.
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 interferon beta-1a used in combination with known hepatotoxic drugs or other products (e.g., alcohol) should be considered prior to interferon beta-1a administration or when adding new agents to the regimen of patients already on interferon beta-1a. For more information, see www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Avonex.
The FDA and Eli Lilly have also notified health care professionals about revisions to the warnings section of labeling for drotrecogin alfa (activated) (Xigris), a biological therapeutic product indicated for the treatment of adult patients with severe sepsis who are at high risk of death. This warning is based upon analyses of two clinical trial databases. Among patients with single organ dysfunction and recent surgery, all-cause mortality was numerically higher in the drotrecogin alfa (activated) group compared to the placebo group. Patients with single-organ dysfunction and recent surgery may not be at high risk of death and therefore may not be among the indicated population. Drotrecogin alfa (activated) should be used in these patients only after careful consideration of the risks and benefits. For more information, see www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Xigris.
The FDA and Biogen have notified health care professionals of revisions to the warnings, precautions/drug interactions, and adverse reactions/post-marketing experience sections and medication guide of interferon beta-1a (Avonex). Severe hepatic injury, including cases of hepatic failure, has been reported in patients taking interferon beta-1a.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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