On August 30, 2012, the FDA issued a Safety Announcement that recommended that Revatio, a drug used to treat pulmonary arterial hypertension (PAH) or high pressure in the blood vessels leading to the lungs, not be prescribed for children between the ages of 1 and 17. Revatio may not sound familiar, nor will its chemical name, Sildenafil. However, everyone will recognize Sildenafil when told it is also marketed as VIAGRA. Both Revatio and VIAGRA are prescribed for the FDA approved treatment of erectile dysfunction (inability to get or maintain an erection) in men. As if this reason alone is not reason enough not to prescribe Revatio for children with pulmonary arterial hypertension, it is now known that giving Sildenafil to children significantly increases the potential risk of death.
Now known only because the FDA learned of this increased risk from a 16 week study of 234 patients with PAH who ranged in age from 1 year old to 17 years old. This study was designed to see if Revatio increased the exercise capacity of these young patients. As referenced above, it did not result in a statistically significant improvement in exercise capacity in those patients. Put another way, being absolutely no benefit of this therapy, the risk outweighed the benefit. Further, the higher the dose the more increased the risk, and the lower the dose the less effective the therapy.
Again, the study found absolutely no benefit of this therapy for children 17 years of age and younger. So why prescribe such a dangerous drug to a child? Doctors have been prescribing it as an off label use since its FDA approval on June 3, 2005. Off label means that the use is not approved by the FDA. The prescribing physicians learned of the off label use by the PFIZER drug reps who positioned the drug for that off label use. Positioned is the word used by PFIZER and all other drug companies who encourage doctors to prescribe it for non-approved uses because promoting and marketing for off label use is illegal.
One dares to think what other problems might occur when children 17 years of age and younger are given a drug to treat erectile dysfunction, but it gives a pretty good idea of why Revatio’s use for children under the age of 17 who have pulmonary arterial hypertension is not FDA approved.