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Viagra for blue babies likely to be trialled

Owen Dyer London

The efficacy and safety of sildenafil (Viagra) as a treatment for pulmonary hypertension is likely to be tested in at least one controlled trial, after controversy was stirred by reports that the drug is being given to newborns with "blue baby" syndrome (27 July, p 181).

The drug has been used on babies at the Royal Brompton Children's Hospital in London and several other centres around the world. The science magazine New Scientist reported that children as young as 8 hours old have also been given the drug at Boston Children's Hospital and Toronto's Hospital for Sick Children. As reported in the BMJ, it has also been used at the Amrita Institute of Medical Sciences in Kochi, India. The results are described as better than those achieved with the standard treatment, inhaled nitric oxide.

Last year, six adult patients with pulmonary hypertension at the Western Infirmary in Glasgow were also treated with sildenafil.

Pfizer, the drug's manufacturer, will fund an international multicentre trial that will test an injectable form of sildenafil citrate among adults with pulmonary hypertension. A trial to test the drug in children also seems likely, but a spokeswoman for the pharmaceutical company would only say that they were looking into the possibility of such a study. She added, however, that "it would remain a specialist treatment for what is fortunately a rare condition and would only be administered by specialists in that condition."

Dr Ian Adatia, director of the pulmonary hypertension clinic at Toronto's Hospital for Sick Children, has been giving oral sildenafil to children refractory to other treatments under a "compassionate use" programme agreed by the hospital's ethics committee.

"We've seen very few of the problems typically associated with vasodilators, and we think we've got the dosing right," he said. He expects to participate in a multicentre paediatric trial that will probably study both oral and intravenous forms of sildenafil, and he also hopes to publish his own clinic's findings to date.

To date, the only research on sildenafil for pulmonary hypertension was published in the journal Circulation (2002;105:2398-403); it looked at the drug's effects in adults. The author of that study, Evangelos Michelakis of the University of Alberta, Canada, was quoted in the New Scientist criticising the paediatric use of sildenafil.

But he told the BMJ: "I never said any of that. In fact I specifically think it's a very attractive therapy for kids. I'm more worried about all the GPs in the US who are now giving Viagra to adults who either have incorrect diagnoses of pulmonary hypertension, or who have PHT [pulmonary hypertension] secondary to other conditions that won't be helped by sildenafil."
 
 
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