Questioning kids' over-the-counter cold medicines: AMNews interviews Joshua Sharfstein, MD, MPH

Washington -- Opting for action over the status quo, a group of Baltimore physicians decided to challenge common perceptions that children's over-the-counter cold and cough medicines are safe and effective. They believe the products are neither.

Led by the city's health department, the group brought a citizens' petition to the Food and Drug Administration asking that the agency tell parents that the products never were found to be safe or effective for this young population. The FDA is now considering the matter and, at press time in December 2007, the final decision was still pending. "We are working intently to provide a public statement in the near future," an agency spokeswoman said.

Meanwhile, the issue has attracted national attention. Some manufacturers already have withdrawn cold and cough products intended for use by children age 2 and younger.

The concerns expressed in the petition, which was joined by physicians from several other states, were heard in October 2007 by an FDA advisory committee. The agency is now considering the panel's recommendations that the products, which have been available for decades, not be used by children younger than 6 and be banned from use by children younger than 2. Although the agency does not have to follow its advisory panels' advice, it often does so.

The manufacturers responded to the advisory panel's recommendations by stressing the safety of their products when they were used as directed and pledging to work with the FDA to devise trials to confirm correct dosing instructions.

Baltimore Health Commissioner Joshua Sharfstein, MD, MPH, was instrumental in bringing the petition to the FDA. He spoke recently with American Medical News about the steps that led to this action and what he hopes to see happen next.

AMNews: Why go after children's cold and cough medicines when there are so many other health issues of concern?

Dr. Sharfstein: There were four deaths of kids over the past six years in Baltimore that were related to overdoses of cough and cold medicines. I think that was one of the factors that led the physicians in Baltimore to get involved. Also, in all my medical training, I don't think there was an area where there was a bigger discrepancy between the medical evidence and actual practice.

AMNews: Just how did the petition evolve?

Dr. Sharfstein: This started in October 2006 when the chiefs of pediatrics of all the hospitals in our city signed a statement urging parents not to give these medicines to their kids. It was actually a joint operation between the pediatric chiefs and the health department.

After we did that, we had people asking, 'Look, if you have all these experts saying don't use them, how can they [the cold and cough medicines marketed for children] be so ubiquitous?'

AMNews: Why do you suppose it took so long for someone to question the use of these products?

Dr. Sharfstein: I don't have a good answer for that.

AMNews: Was it difficult to bring this petition?

Dr. Sharfstein: No. Once we had the momentum from the statement that we wrote, it was pretty straightforward to ask the FDA to look at the evidence again. The FDA responded very quickly.

AMNews: Given the questions the FDA posed to their advisory committee, for example, asking whether the medications should be used by children younger than 6 years old, were your concerns addressed?

Dr. Sharfstein: I was a little disappointed that the questions put to the advisory committee didn't line up completely with the petition -- although I thought the panelists were able to see an enormous amount of data and hear from multiple perspectives and make a reasoned assessment. I thought overall they did an excellent job.

AMNews: What was left out?

Dr. Sharfstein: The basic question of whether these products have been demonstrated to be safe and effective was not actually asked directly. I think that was an oversight. They were asked whether immediate action was necessary in kids 3 to 5, and the answer to that was yes.

AMNews: Any feedback on when the FDA may make a decision?

Dr. Sharfstein: No.

AMNews: Does your action speak to the ability of physicians to change common practice?

Dr. Sharfstein: Yes. But it wasn't just because I brought the petition. Initially we started with the Baltimore doctors, but by the time we sent the petition in, we had physicians from all over the country. Senior pediatricians joined us. I think that if I had just sent it, it wouldn't have had any impact. But a whole bunch of doctors getting together made them pay attention.

AMNews: Are you satisfied that you and your fellow petitioners moved this issue forward?

Dr. Sharfstein: It has definitely moved forward, but it has further to go. Getting all the products for kids under 2 removed was a very good step. But there are still kids in harm's way.