The FDA has just issued new warnings in the package inserts for alpha interferons
The FDA has just issued new warnings in the package inserts for alpha interferons. These warnings include significant label changes and safety issues.
Several serious events have been identified in recent months related to reported experiences with alpha interferon products. Labeling for alpha interferon products has been updated in order to incorporate each of these class safety issues into all product labels.
Each approved alpha interferon product will now include statements regarding possible risk of
• stroke
• serious retinal detachment
• peripheral neuropathy
• pulmonary hypertension
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration