Though heart disease is known to run in my family, it’s not congenital and usually, it develops later in life. An increasingly common drug called Plavix has been used to help prevent stroke, heart attack, and other heart problems. It’s a blood thinner, and with the combined use of aspirin, it has been very effective for managing congenital heart problems and heart problems in general. There is a problem with this drug, however, and that’s what it is typically meant for adults. Why is this a problem? Well, because for many years, it’s been given to infants with congenital heart diseases in small doses.

Recently one of the largest clinical trials done on infants with congenital heart diseases was conducted by a research team led by David Wessel, Chief Medical Officer at Children's National Medical Center. The study found that clopidogrel, or Plavix, which is used to reduce shunt-related blood flow issues in infants, is not effective in the dose that is usually used.

"Once again, pediatric-specific research shows that newborns and infants are not little adults,” says Wessel. "The takeaway message for pediatric cardiac care providers is to reconsider the use of Plavix in certain cases. In pediatric medicine, the assumption is that smaller doses of a drug that works in adults will work in infants, but our study shows that this is not true for these young patients. For the parents of these fragile newborns, it is important to understand that research informs best practices, and they need to be informed advocates for their children."

Since 2001, the use of Plavix has been increasing in children’s hospitals without sound evidence that it actually made the normal treatment more effective. The study included 900 patients seen across 134 centers in 33 countries, and it evaluated the effectiveness of Plavix compared with a placebo for the reduction of all-cause mortality and shunt-related morbidity in neonates and infants with cyanotic congenital heart disease palliated with systemic-to-pulmonary artery shunts.

The participants were all treated with aspirin, which is the typical treatment for thrombosis in neonatal infants, but some were given Plavix in addition to the aspirin and some were given a placebo. The typical treatment for adult patients who develop the same type of thrombosis is a mixture of aspirin and Plavix. The study showed that while Plavix works well in combination with aspirin for adults, it has no added benefit for infants.

More analysis of the data also revealed the aspirin alone would be the most effective treatment for thrombosis in newborns. Along with this, the study showed that there could be negative effects when switching from aspirin alone to Plavix alone.

Source: Children's National Medical Center (2013, June 20). Study on fragile newborns challenges current practices. ScienceDaily.