Study questions safety of free drug samples for children

Children who receive free samples of prescription drugs from their doctors may be risking safety problems, a new study says.

Four of the 15 medications most frequently given out as free samples to more than 10,000 children in a 2004 national survey later had black-box warnings placed on them or significant changes made to these safety warnings, researchers from Cambridge Health Alliance and Hasbro Children's Hospital report in Pediatrics. Black-box warnings --- named for their appearance on drug information given to prescribers -- are the strongest cautions the Food and Drug Administration gives.

"I think the safety of free drug samples must be further examined," Dr. Sarah L. Cutrona, lead author and an internal medicine specialist at Cambridge Health Alliance, said in an interview. "Giving free samples to children in nonurgent situations is really an unproven medical practice that should be undertaken very cautiously or perhaps needs to stop."

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."