Don't give sildenafil to children, FDA warns

September 13, 2012

Children aged between 1 and 17 years should not take sildenafil for pulmonary artery hypertension, a MedWatch safety communication from the US Food and Drug Administration (FDA) warns. More >>

Children aged between 1 and 17 years should not take sildenafil for pulmonary artery hypertension, a MedWatch safety communication from the US Food and Drug Administration (FDA) warns.

FDA based its recommendation on a long-term pediatric clinical trial that found a greater risk of death among children who took a high dose of sildenafil than for children who took a low dose. Low doses of the drug did not improve exercise ability in treated children.

Sildenafil is approved to enhance exercise ability in adults with pulmonary artery hypertension and slow the progression of the condition by relaxing the blood vessels in the lungs and lowering blood pressure. Treatment of pediatric pulmonary artery hypertension with sildenafil is an off-label use.

FDA has added a new warning to the drug’s labeling stating that sildenafil is not recommended for pediatric patients. Caregivers of children taking the drug should consult a health care professional before discontinuing it or changing the dose.

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