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U.S. Department of Health and Human Services

Safety

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Viagra (sildenafil citrate) tablets

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

 

March 2014

Summary View

WARNINGS AND PRECAUTIONS

Effects on the Eye
  • Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 in males aged ≥ 50. An observational study evaluated whether recent use of PDE5 inhibitors, as a class, was associated with acute onset of NAION. The results suggest an approximate 2 fold increase in the risk of NAION within 5 half-lives of PDE5 inhibitor use.

 

January 2011

Summary View

WARNINGS

  • There is no controlled clinical data on the safety or efficacy of VIAGRA in the following groups; if prescribed, this should be done with caution…...
    • Patients with sickle cell or related anemias.

ADVERSE REACTIONS

Postmarketing Experience
  • Hemic and Lymphatic: Vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO in patients with pulmonary hypertension (PH) secondary to sickle cell disease, vasoocclusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with VIAGRA for ED is not known.

 

January 2010

Summary View

PRECAUTIONS

Information for Patients
  • Physicians should inform patients not to take Viagra with other PDE5 inhibitors including Revatio. Sildenafil is also marketed as Revatio for the treatment of pulmonary arterial hypertension. The safety and efficacy of Viagra with other PDE5 inhibitors, including Revatio, have not been studied.