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

Concerns about OTC cough and cold medicines had simmered for decades in the medical community. Now some physicians have brought the issue forward.

By Susan J. Landers, AMNews staff. Jan. 14, 2008.

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 Some manufacturers already have withdrawn cold and cough products intended for use by children age 2 and younger.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.