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.
The FDA advises that patients and caregivers should NOT change the Revatio dose or stop taking Revatio without talking to a healthcare professional.
In addition, PHA’s Scientific Leadership Council will be releasing a statement in the near future. PHA is exploring the ramifications of this FDA ruling and the best way to support the pediatric PH community.