Revatio, a phophodiesterase-5 inhibitor manufactured by Pfizer, is commonly used to treat adults with pulmonary arterial hypertension (PAH) by relaxing blood vessels in the lungs, allowing blood to flow easily. It is also used to improve exercise ability for those with PAH. Although Revatio has not been approved for FDA use of PAH in children, has commonly been prescribed off-label to help children with high blood pressure in the vessels to improve lack of exercise ability due to PAH.


The FDA has strongly warned against the use of Revatio for PAH use in children. This is based on a clinical trial finding that assert the drug may cause increased risk of death under high doses as compared to lower doses. The trial also found that the drug does not improve a child’s exercise ability even under lower doses. Milder side effects may include headache, heartburn, diarrhea, or muscle aches.


Following the findings of the clinical trial in children, Pfizer is now required by the FDA to evaluate the risk of Revatio use in adults and its risk of death. Revatio lawsuits are currently being evaluated nationwide as a result of injuries in children stemming from the off-label use of the drug.