FDA Warns of Revatio Risks for Children with Pulmonary Hypertension

Federal health officials indicate that side effects of Revatio may pose an increased risk of death for children when the hypertension drug is prescribed off-label for treatment of pediatric cases of pulmonary arterial hypertension (PAH).

In a drug safety communication issued on August 30, the FDA indicated that Revatio (sildenafil) should not be prescribed off-label to children between the ages of 1 and 17.

The warning comes after new clinical data found that children taking high-doses of Revatio for pulmonary arterial hypertension have an increased risk of death and that low doses are not effective in improving exercise ability.

Revatio is a phophodiesterase-5 inhibitor, which is manufactured by Pfizer. The medication is commonly used to treat adults with PAH by relaxing the blood vessels in the lungs, allowing blood to flow easily. It is also commonly used to improve the ability to exercise with people who have PAH.

The FDA indicates that Revatio has not been approved for treatment of PAH in children, but it has been commonly prescribed off-label to help children with high pressure in the blood vessels leading to the lungs improve their ability to exercise. However, the FDA is now strongly warning against off-label use of Revatio for pulmonary hypertension in children.

Pulmonary arterial hypertension (PAH) causes shortness of breath, dizziness and tiredness, resulting in the right side of the heart working harder than normal due to the constriction of the vessels. Over time this can also result in the enlargement of the right side of the heart. Other symptoms may include ankle or leg swelling and chest pain or pressure.

While drug companies are barred from marketing drugs for uses not approved by the FDA, doctors can generally prescribe drugs off-label for any treatment they see fit.

Due to the risks of off-label Revatio use with children, the FDA has issued the drug safety announcement and provided new information on the drug label indicating that it is not recommended for pediatric patients.

The warning is based on findings from a long-term clinical trial that found Revatio to increase a child’s risk of death under high doses compared to children taking a lower dosage. The trial also found that under low doses of the drug it does not effectively improve a child’s exercise ability. Other less severe symptoms of taking Revatio may include headache, heartburn, diarrhea and muscle aches.

The clinical trial of Revatio was a double-blind placebo-controlled trial of children between the ages of one and 17 years old who suffer from mild to moderate symptoms of PAH. The majority of the deaths were caused by pulmonary hypertension and heart failure.

There are no studies concerning the use of Revatio in adults or the risk of death with long-term use for adults. Following the findings of the clinical trial in children, the FDA is requiring Pfizer to evaluate the use of Revatio in adults and the risk of death it may pose.

The active ingredient in Revatio, sildenafil, is also contained in the popular sexual enhancement drug Viagra, which is used to treat erectile dysfunction, or impotence, in male patients by increasing blood flow to the penis.