Reuters: Regulatory News: FDA warns against use of Pfizer's Revatio in children

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FDA warns against use of Pfizer's Revatio in children Aug 30th 2012, 22:38 Thu Aug 30, 2012 6:38pm EDT Aug 30 (Reuters) - U.S. health regulators recommended against use of Pfizer Inc's pulmonary arterial hypertension (PAH) drug Revatio in children up to 17 years of age, saying it had a higher risk of death when taken in a high dose. While the drug has never been approved for treatment of PAH in children, the U.S. Food and Drug Administration's warning is against off-label use of the drug. Revatio, which has the same active ingredient as Pfizer's erectile dysfunction drug Viagra, is used to improve the ability to exercise in people with PAH -- or high blood pressure in the vessels carrying blood to the lungs. The FDA said the recommendation against the use of the drug is based on a recent clinical trial, and the Revatio drug label will carry the warning.

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