* The labeling of the vasodilating drug Revatio (a formulation of sildenafil) has been revised to say that the drug shouldn't be used off label to treat children with pulmonary hypertension.
* Clinical trials in pediatric patients have found that the drug increases the risk of death from pulmonary hypertension when it's taken in large doses.
* It's currently not known whether the risk of death is greater in adults taking Revatio for pulmonary hypertension. The Food and Drug Administration has ordered the manufacturer to conduct clinical trials to answer that question.
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