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U.S. Department of Health and Human Services

Safety

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Revatio (sildenafil) Tablets and Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2010

 

Summary View

 

WARNINGS AND PRECAUTIONS

Pulmonary Hypertension Secondary to Sickle Cell Anemia
  • In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received Revatio than by those randomized to placebo. The effectiveness of Revatio in PH secondary to sickle cell anemia has not been established.

ADVERSE REACTIONS

  • Vaso-occlusive crisis