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T98-83                             Print Media: 301-827-6242
November 24, 1998                  
                                   Consumer Media: 888-Info-FDA

Pfizer Updates Viagra Labeling

FDA and Pfizer Inc. are advising doctors about new warnings and information in the product labeling for Viagra (sildenafil) in response to postmarketing reports of serious adverse events. The new information augments the original drug labeling which warned against the concomitant use of Viagra and nitrates.

Revised in consultation with FDA, the new labeling is intended to help make sure that consumers and doctors are fully informed about the benefits and risks of using Viagra, know that consideration must be given to the cardiovascular status of patients prior to prescribing Viagra, and know how to safely use the drug.

As with all approved drugs, there have been postmarketing reports of important side effects with Viagra. These have been reviewed carefully by FDA since Viagra's approval in April l998. Although a causal relationship cannot be established from these reports, they are being mentioned in the labeling. FDA typically requires manufacturers to update their labeling with such information. It is important to note that the postmarketing reports involving Viagra constitute only a small fraction of the more than six million prescriptions written for this drug. FDA continues to believe Viagra is safe and effective if used according to the updated labeling.

The company is providing the updated information about the serious postmarketing events in a letter to health professionals.

The labeling notes that it is not possible at present to determine whether the cardiovascular events are directly related to Viagra, to sexual activity, to the patient's underlying disease, or to a combination of these factors.

Information added to the labeling includes:

  • Postmarketing cardiovascular events: The revised labeling addresses postmarketing reports of heart attacks, sudden cardiac deaths, and hypertension.
  • Risk of sexual activity: Sexual activity in patients with preexisting cardiovascular disease carries a potential cardiac risk. Pfizer, therefore, advises doctors that treatments for impotence, including Viagra, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.
  • Vasodilatory effects (effects on blood pressure): Physicians should consider whether their patients with heart disease could be affected by transient decreases in blood pressure, especially in combination with sexual activity.
  • Patients who were not studied in clinical trials: Several groups of patients were not studied in the clinical trials for Viagra. The new labeling notes that if Viagra is prescribed for these patients, it should be done with caution. These include patients who:
    - suffered a heart attack, stroke, or life-threatening arrhythmia within the previous six months,
    - had significant hypotension (lowered blood pressure) or hypertension (uncontrolled high blood pressure of greater than 170/110),
    - had a history of cardiac failure or coronary artery disease causing unstable angina, and
    - had retinitis pigmentosa, an eye disorder.
  • Prolonged erections or priapism: The labeling now includes a warning about the rare occurrence of painful, prolonged erections. This is a serious condition that requires immediate medical attention. The labeling advises patients to seek prompt medical attention if their erection last longer than four hours.

    Health care professionals are encouraged to report any unexpected adverse or serious events associated with the use of Viagra (sildenafil) directly to Pfizer Inc. at 1-800-438-1985 or to the FDA MedWatch program at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail (MedWatch, HF2, FDA, 5600 Fishers Lane, Rockville, MD 20857).

    For more information on this subject, go to the Center for Drug Evaluation and Research's Viagra Information page.

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