Viagra (sildenafil citrate) Information

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FDA/Center for Drug Evaluation and Research

FDA has new safety information about this drug, please see http://www.fda.gov/cder/consumerinfo/viagra/default.htm
The NAION issue described in the Alert has been addressed in product labeling; please see Drugs@FDA

FDA ALERT [7/2005]:

A small number of men have lost eyesight in one eye some time after taking Viagra, Cialis, or Levitra. This type of vision loss is called non-arteritic anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss of eyesight because blood flow is blocked to the optic nerve.

We do not know at this time if Viagra, Cialis, or Levitra causes NAION. NAION also happens in men who do not take these medicines. People who have a higher chance for NAION include those who:

have heart disease
are over 50 years old
have diabetes
have high blood pressure
have high cholesterol
smoke
have certain eye problems

FDA has approved new labels for Viagra, Cialis, and Levitra to include information on possible eyesight loss (NAION).

Stop using Viagra, Cialis, or Levitra if you have a loss in your eyesight. Get medical help right away.

Patient Information Sheet [PDF] [HTML] (7/8/2005)
Professional Information Sheet [PDF] [HTML] (7/8/2005)
FDA Statement (7/8/2005)
Label (7/8/2005)

Background Information

The FDA approved Viagra on March 27, 1998. Viagra is the first oral pill to treat impotence, a dysfunction that affects millions of men in the United States. Viagra is manufactured by Pfizer Pharmaceuticals, New York, NY.

Revised Viagra Label (9/19/2004)
FDA Talk Paper--Pfizer Updates Viagra Labeling (11/24/1998)
New Viagra Prescribing Information (11/24/1998)
FDA Labeling Supplement Approval Letter (11/24/1998)
Revised Viagra Label (11/24/1998)
Dear Health Professional Letter About Viagra (Safety Notice) (5/1998)
FDA Talk Paper on Viagra Approval (3/27/1998)

Viagra Approval Letter (3/27/1998)

Questions and Answers about Viagra (3/27/1998)
Amendment to Clinical Review of 22 January 1998: Effects of Sildenafil on the Electroretinogram in Study 148-232 (5/13/1998)

FDA's Clinical, Statistical and Biopharmacological Review of Viagra Clinical Development
1. Cover Sheet (3/27/1998)
2. Joint Clinical Reviews (3/27/1998)
  
  A. Table of Contents
  B. Sections 1-6
  C. Section 7
  D. Section 8
  E. Section 9-10
  F. Appendix A, Sections 1-4
  G. Appendix A, Sections 5-9
  H. Appendix A, Sections 10-13
  I. Appendix A, Sections 14-22
  J. Appendix A, Sections 23-33
  K. Appendix A, Sections 34-43
  L. Appendix A, Sections 44-51
  M. Appendix A, Sections 52-56
1. Chemistry Review (3/27/1998)
2. Pharmacology Reviews (3/27/1998)
  
  A. Review and Evaluation of Pharmacology and Toxicology Data, Pages 1-25
  B. Review and Evaluation of Pharmacology and Toxicology Data, Pages 26-48
  C. Review and Evaluation of Pharmacology and Toxicology Data, Pages 49-65
  D. Review and Evaluation of Pharmacology and Toxicology Data, Pages 66-90
  E. Review and Evaluation of Pharmacology and Toxicology Data, Pages 91-116
  F. Review and Evaluation of Pharmacology and Toxicology Data, Pages 117-142
3. Statistical Carcinogenicity Reviews (3/27/1998)
  
  A. Carcinogenicity Review of Sildenafil in Rats and Mice
  B. Appendix A, Male Rats
  C. Appendix B, Female Rats
  D. Appendix C, Male Mice
  E. Appendix D, Female Mice
4. Carcinogenicity Assessment Committee and FDA/CDER Rodent Carcinogenicity Database Factsheet (3/27/1998)
5. Administrative Documents (3/27/1998)
6. Correspondence (3/27/1998)

Some of these documents are in Portable Document Format (PDF) to retain the original format. To view or print these documents, you must use the Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's website with full installation instructions.

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Date created: July 8, 2005, updated November 14, 2007