Alert: PHA Canada statement regarding FDA Revatio decision


The U.S. Food and Drug Administration (FDA) has issued a decision regarding sildenafil (Revatio) for pediatric usage. More information can be found in FDA’s Medwatch and Pfizer’s statements.

Based on an interpretation of the same study used in the FDA's decision, the European Medicines Agency has approved the use of sildenafil (Revatio) in children.

PHA Canada’s Medical Advisory Committee in conjunction with pediatric PH specialists across the country will be releasing a statement on this decision in the near future.

In the meantime, please note that the FDA’s decision does advise that patients and caregivers should NOT change the Revatio dose or stop taking Revatio without talking to a healthcare professional. Please see your child’s pediatric PH specialist if you have concerns.

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