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FDA: Sildenafil should not be used in children with pulmonary hypertension
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The FDA today announced its recommendation against the use of sildenafil in children aged 1 through 17 years for pulmonary arterial hypertension, according to a press release.
The agency based its recommendation on a recent long-term clinical pediatric trial demonstrating that children taking a high dose of sildenafil (Revatio, Pfizer) had a heightened risk for death, as compared with children taking a low dose. Additionally, data showed that low doses of sildenafil are not effective in improving exercise capability, the release stated. Pulmonary hypertension and HF were the most common causes of death in the trial.
The FDA’s drug safety communication noted that sildenafil has never been approved for the treatment of pulmonary arterial hypertension in children and the new clinical trial information further emphasizes the fact that off-label use of sildenafil is not recommended in pediatric patients.
Information added to sildenafil’s labeling includes:
- A new warning stating that the use of sildenafil is not recommended in pediatric patients.
- Results of the sildenafil trial in pediatric patients.
Sildenafil is approved to improve exercise ability and delay clinical worsening of pulmonary arterial hypertension in adult patients. Currently, the drug’s label recommends avoiding doses higher than 20 mg administered three times daily. The effect of sildenafil on the risk for death with long-term use in adults is unknown; and the FDA is requiring the manufacturer to evaluate the drug’s effect on the risk for death in adults with pulmonary arterial hypertension.