FDA Warns Against Using Pfizer Inc.'s Revatio in Children

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.

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