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U.S. Department of Health and Human Services


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Agrylin (anagrelide hydrochloride) Capsules

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


  • Interstitial Lung Diseases


  • Carcinogenesis, Mutagenesis, Impairment of Fertility
    • In a two year rat carcinogenicity study a higher incidence of uterine adenocarcinoma...
  • Pregnancy
    • ...There are however, no adequate and well controlled studies with anagrelide hydrochloride in pregnant women.
  • Nonclinical Toxicology
    • Initial Paragraph


  • Postmarketing Reports (new subsection)


Interstitial Lung Diseases

Interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis) have been reported to be associated with the use of anagrelide in post-marketing reports. Most cases presented with progressive dyspnea with lung infiltrations. The time of onset ranged from 1 week to several years after initiating anagrelide. In most cases, the symptoms improved after discontinuation of anagrelide...