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The Food and Drug Administration is warning physicians not to use off-label Revatio (sildenafil) to treat pulmonary arterial hypertension in children younger than 18 years.
The FDA made the announcement after a pediatric trial revealed high doses of Revatio increased mortality, and low doses failed to improve exercise ability among young PAH patients.
Revatio is a phosphodiesterase-5 inhibitor approved by the FDA to improve exercise ability and delay the progression of PAH in adults. However, the drug is not approved for treatment in children.
Results from a recent randomized, controlled study of Revatio use in 234 children aged 1-17 years with mild to moderate PAH demonstrated that low doses of the drug didn’t improve patients’ exercise ability. In addition, the mortality rate among children taking high doses of Revatio was 3.5 times greater than that of children taking low doses, a statistically significant difference.
The FDA has added a warning to Revatio’s labeling stating that the drug is not recommended for pediatric patients. The agency also has required the drug’s manufacturer, Pfizer, to evaluate Revatio’s mortality risk in adults.
Physicians can report adverse side effects involving Revatio to the FDA MedWatch program.
The Food and Drug Administration is warning physicians not to use off-label Revatio (sildenafil) to treat pulmonary arterial hypertension in children younger than 18 years.
The FDA made the announcement after a pediatric trial revealed high doses of Revatio increased mortality, and low doses failed to improve exercise ability among young PAH patients.
Revatio is a phosphodiesterase-5 inhibitor approved by the FDA to improve exercise ability and delay the progression of PAH in adults. However, the drug is not approved for treatment in children.
Results from a recent randomized, controlled study of Revatio use in 234 children aged 1-17 years with mild to moderate PAH demonstrated that low doses of the drug didn’t improve patients’ exercise ability. In addition, the mortality rate among children taking high doses of Revatio was 3.5 times greater than that of children taking low doses, a statistically significant difference.
The FDA has added a warning to Revatio’s labeling stating that the drug is not recommended for pediatric patients. The agency also has required the drug’s manufacturer, Pfizer, to evaluate Revatio’s mortality risk in adults.
Physicians can report adverse side effects involving Revatio to the FDA MedWatch program.
The Food and Drug Administration is warning physicians not to use off-label Revatio (sildenafil) to treat pulmonary arterial hypertension in children younger than 18 years.
The FDA made the announcement after a pediatric trial revealed high doses of Revatio increased mortality, and low doses failed to improve exercise ability among young PAH patients.
Revatio is a phosphodiesterase-5 inhibitor approved by the FDA to improve exercise ability and delay the progression of PAH in adults. However, the drug is not approved for treatment in children.
Results from a recent randomized, controlled study of Revatio use in 234 children aged 1-17 years with mild to moderate PAH demonstrated that low doses of the drug didn’t improve patients’ exercise ability. In addition, the mortality rate among children taking high doses of Revatio was 3.5 times greater than that of children taking low doses, a statistically significant difference.
The FDA has added a warning to Revatio’s labeling stating that the drug is not recommended for pediatric patients. The agency also has required the drug’s manufacturer, Pfizer, to evaluate Revatio’s mortality risk in adults.
Physicians can report adverse side effects involving Revatio to the FDA MedWatch program.