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U.S. Department of Health and Human Services

Safety

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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

WARNINGS

  • Interstitial Lung Diseases

PRECAUTIONS

  • 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

ADVERSE REACTIONS

  • Postmarketing Reports (new subsection)

WARNINGS

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...