FDA warns against use of Pfizer's Revatio in children
Key points
- 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.
- 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.
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)
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(Reuters)
Written and revised by
Gerald Hurowitz, M.D.
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