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Source: MedpageToday.com, Newsweek Magazine July 25, 2005 Issue

Doctors are Feeding Newborn Babies Viagra

Doctors are feeding Viagra to newborn babies and possibly killing them in the name of research.

In a poster presentation at the Pediatric Academic Societies' annual meeting, Amed Soliz, M.D., director of the Neonatal Intensive Care Unit at Miami Children's Hospital, detailed a randomized trial of 49 infants with failure in both the systemic and pulmonary circulation. Those who received sildenafil (Viagra) showed a significant improvement in oxygenation and had a 92% survival rate, compared with a 50% survival rate of neonates who received placebo, he said.

They were trying to see if Viagra can be used as a substitute for the more common procedure of administering nitric oxide. In the U.S. and other developed countries, inhaled nitric oxide effectively treats infants with persistent pulmonary hypertension. But the gas is either unavailable or prohibitively expensive at most treatment centers in developing countries.

On the other hand, Viagra -- a type V phosphodiesterase inhibitor primarily used for erectile dysfunction in adults -- is widely available for $5 to $10 per adult dose in developing areas, Dr. Soliz said.

The drug, originally developed to treat hypertension and angina, works in persistent pulmonary hypertension patients by selectively reducing pulmonary vascular resistance. It is not FDA approved for newborns.

Although smaller studies have shown the drug's utility in treating persistent pulmonary hypertension, the current study is the largest to date. For the study, Dr. Soliz and colleagues randomized 49 neonates at three centers in Mexico and El Salvador to either sildenafil or placebo.

After crushing and diluting a 2 mg/kg dose of the normally adults-only pill, doctors administered the medication to the test group by orogastric tube every six hours from birth to three days.

Not discussed during the presentation was whether the 50% mortality rate among the placebo group meant that these babies were intentionally denied nitric oxide and allowed to die in the name of research.

Lest you think that giving babies Viagra is something new, Newsweek reported in July, 2005 that Viagra was being used “off label” in the US to treat hypertension in babies. In May, 2005, Viagra therapy for kids with pulmonary hypertension was tested in a small study with 14 children in Toronto and Pfizer, Viagra's maker, was recruiting patients for a large-scale trial as a first step toward marketing the drug for infant use.

Reports of the drug's success in patients with pulmonary hypertension have fueled an explosion in "off label" prescriptions. Hundreds of children in the US have already been treated with Viagra, One pulmonologist who prescribes Viagra to children, Steven Abman, urges caution. "We feel the benefits outweigh the unknowns if the child's pulmonary hypertension is severe enough," he says. "But we certainly do not know the long-term complications, especially in young infants." Some parents report increased aggression in their children, and doctors are concerned that the drug may affect the developing retina, leading to problems in later life.

Nevertheless, many parents are convinced Viagra is effective.