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U.S. Department of Health and Human Services

Safety

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Intron A (interferon alfa-2b, recombinant) For Injection


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Cerebrovascular Disorders

MEDICATION GUIDE - Intron A Multidose Pen for Injection

  • The most serious possible side effects of Intron A include:
    • Body Organs Problems
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.

MEDICATION GUIDE - Intron A Solution for Injection

  • The most serious possible side effects of Intron A include:
    • Body Organs Problems
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.
  • For Intramuscular Injection
    • ...If after using a multidose vial (18 million IU or 25 million IU) there is enough solution...

MEDICATION GUIDE - Intron A Powder for Injection

  • The most serious possible side effects of Intron A include:
    • Body Organs Problems
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WARNINGS

Cerebrovascular Disorders

Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alpha-based therapies, including Intron A. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alpha-based therapies and these events is difficult to establish.

 

Label approved 05/02/2008 is not available on Drugs@FDA