In an August 30 safety communication, the FDA indicated that Revatio (sildenafil) should not be prescribed off-label to children between the ages of 1 and 17 for pulmonary arterial hypertension (PAH), due to an increase in mortality.
This recommendation is based on a recent long-term clinical pediatric trial showing that children taking a high dose of Revatio had a higher risk of death than children taking a low dose; and the low doses of Revatio are not effective in improving exercise ability. The FDA stressed the drug has never been approved for treatment of PAH in children.
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.
What Is Pulmonary Arterial Hypertension?
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.
Revatio is a phosphodiesterase-5 inhibitor used to treat PAH by relaxing the blood vessels in the lungs to reduce blood pressure. It is approved to improve exercise ability and delay clinical worsening of PAH in adult patients.
Patients and caregivers are advised to not change the Revatio dose or stop taking Revatio without talking to a healthcare professional. Healthcare professionals were reminded that use of this product, particularly chronic use, in children is an off-label indication, not approved by FDA, and is not recommended.
This decision was based on a randomized, double-blind, multicenter, placebo-controlled, parallel-group, dose-ranging clinical trial. In the trial, 234 patients with PAH, 1 to 17 years of age, were randomized to low-, medium-, or high-dose sildenafil (administered three times per day) or placebo for 16 weeks of treatment.
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.
Revation (Sildenafil) is the same active ingredient found in Pfizer’s erectile dysfunction drug Viagra. At this time, the FDA does not believe that the same concern applies to Viagra, given the differences in patient population and the different recommended dosing regimens.