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Advisers weigh Viagra's use to treat disorder in kids

WASHINGTON - A form of Viagra, sold as the blood-pressure treatment called Revatio in adults, may be used for children with a rare lung disorder if federal regulators can agree on how to test it.

The condition, called pulmonary arterial hypertension, affects only 600 children a year, said New York-based Pfizer Inc., which makes the drugs. The disorder causes high blood pressure in arteries in the lungs, making the right side of the heart work harder than normal and causing chest pain, dizziness and fatigue.

Outside advisers to the Food and Drug Administration are set to meet Thursday to evaluate whether Pfizer's study of Revatio is sufficient to determine its effectiveness in children, the agency said yesterday.

If the New York-based company meets FDA requirements, the drug would get an extra six months on the market without generic competition. Patents on the drug, with 2009 sales of $1.89 billion as Viagra and $450 million as Revatio, are expected to expire in 2012.

Some doctors are already using the treatment in kids with the lung condition.

"It's a good option in pediatric patients because it is well-tolerated, in that it doesn't have as many side effects as some of the other options," said Chad Knoderer, a pediatric clinical pharmacist at Riley Hospital for Children in Indianapolis, who has used Viagra in kids with the disorder.

The FDA in 2001 asked Pfizer, the world's biggest drugmaker, to study the medicine in children with the lung disorder. Sildenafil, the chemical name for both Viagra and Revatio, blocks an enzyme found in the lungs and penis that regulates blood flow. Pfizer is considering whether to seek approval for Revatio, a lower-dose form of sildenafil, in children, said Colin Ewen, an executive director at the company.

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