Off-label use of Revatio for children may have devastating consequences. The U.S. Food and Drug Administration (“FDA”) recently issued a warning about a link between taking high doses of Revatio and an increased risk of death in children. Revatio, a medication prescribed for the treatment of pulmonary arterial hypertension (“PAH”) manufactured by Pfizer, received FDA approval for use in adults in 2005. However, it was never approved to treat PAH in children.

In the August 30, 2012 FDA warning, the FDA advised doctors to stop prescribing Revatio to children ages 1 through 17. The FDA reviewed a long-term clinical pediatric trial which found that children taking a higher dose of Revatio had a higher risk of death than children taking a low dose, and that low doses of Revatio are not effective in improving exercise ability.

Prescribing Revatio to children is considered off-label use. Off-label prescriptions are not illegal, and doctors are generally able to prescribe medications for any off-label treatment they see fit.  The new updated label information makes it clear that Revatio is not recommended as an off-label use for children. If your child took high doses of Revatio and suffered from serious Revatio side effects, contact a Revatio lawyer to learn more about how you may be able to seek compensation for you loss. We are offering free and confidential case reviews. Call (877) 779-1414.

Published September 28, 2012 by