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FDA warns against use of Pfizer's Revatio in children
Thursday, August 30, 2012
(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.
(Reporting by Prateek Kumar in Bangalore; Editing by Maju Samuel)
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.
(Reporting by Prateek Kumar in Bangalore; Editing by Maju Samuel)
Reuters Health
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