Study questions safety of free drug samples for children

Cutrona and her colleagues found that 1 out of 10 children who take prescription medications received free samples and nearly 1 in 20 children overall got free samples in 2004. But poor children or uninsured children were no more likely to get free samples than children who had insurance or whose families were better off.

That finding is consistent with their previous study of free samples given to adults. Pharmaceutical companies have argued that free samples help uninsured, low-income people get the medications they need.

Cutrona's study, which to her knowledge is the first to look at drug samples in pediatric practices, shows that access to medical care is the strongest predictor of getting free samples. The children who had the most medical or dental visits and who saw their doctors in private offices rather than in hospitals or clinics were more likely to get free drug samples.

The four drugs that later received new or revised warnings were the topical immune-suppressing drug Elidel (pimecrolimus), the asthma drug Advair (fluticasone/salmeterol), and the ADHD drugs Strattera (atomoxetine) and Adderall (amphetamine/dextroamphetamine).

Free samples tend to be of newer drugs whose long-term safety has not been established, Cutrona said. In her study on free samples for adults, Vioxx (rofecoxib) topped the list. The painkiller was later recalled after it was tied to dangerous cardiovascular side effects.

"This is an issue that is concerning to me as a physician and a mother," she said. "I am not a pediatrician but part of what we are trying to do is to get the issue on the radar of pediatricians."