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U.S. Department of Health and Human Services

Safety

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Revatio (Sildenafil) Tablets, Oral Suspension and Injection

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 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.10 Use of Sildenafil with Bosentan
  • the section was deleted

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B

  • There are no adequate and well-controlled studies of sildenafil in pregnant women. No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m2 basis, 32- and 68-times, respectively, the recommended human dose (RHD) of 20 mg three times a day. In a rat pre- and postnatal development study, the noobserved-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m2 basis).

PATIENT PACKAGE INSERT

What is REVATIO?

  • Adding REVATIO to another medication used to treat PAH, bosentan (Tracleer), does not result in any added improvement in your ability to exercise

How should I store REVATIO?

  • Throw away REVATIO oral suspension after 60 days.

 

August 2012

Summary View

 

CONTRAINDICATIONS

  • Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension
  • Known hypersensitivity to Sildenafil or any component of the tablet, injection, or oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of Sildenafil.
 

WARNINGS AND PRECAUTIONS

Hypotension
  • Revatio has vasodilatory properties, resulting in mild and transient decreases in blood pressure…
Visual Loss
  • When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including Sildenafil…
Hearing Loss
  • Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including Revatio…