FDA Recommends Against Revatio Use in Children

The Food and Drug Administration (FDA) cautioned that Pfizer’s drug for pulmonary arterial hypertension - Revatio (sildenafil) -  should not be prescribed for children because new research shows high doses of the drug are associated with a greater risk of death in young patients.

Reuters reports that the FDA warning was issued after the findings of a recent pediatric clinical trial.  Revatio is not approved for pediatric use but the FDA’s warning is meant to discourage the off-label use of the drug by doctors in children aged 17 and younger.

The drug’s label will now have to carry a warning stating the pediatric safety risks. As always, consult with a physician before making any changes to a drug regimen.

Revatio has the same active component as Pfizer's erectile dysfunction drug Viagra and is used to improve stamina in people with pulmonary arterial hypertension or PAH, according to Reuters.  PAH involves tightening of blood vessels connected to and within the lungs making it harder for the heart to pump blood through the lungs. Over time, pressure in the blood vessels leading to the lungs increases and the affected blood vessels become both stiffer and thicker.

If you or a loved one has been harmed by a dangerous drug, contact Sokolove Law today for a free legal consultation and to find out if a dangerous drug lawyer may be able to help you

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