Drug Makers Voluntarily Pull Infant Cough, Cold Medications Off Market

Leading manufacturers of over-the-counter cough and cold medications are voluntarily recalling 14 products designed for use in infants "amid rising concerns about the safety of the" treatments, the Washington Post reports (Stein, Washington Post, 10/12).

Earlier this month, FDA safety experts urged the agency to consider a ban on OTC cough and cold medicines for children younger than age six. The recommendation was part of a 356-page safety review of the approximately 800 cold medicines marketed for young children in the U.S.

The preliminary recommendation that young children should not take the popular remedies would apply to decongestants in children younger than age two and antihistamines in children younger than six. FDA officials also recommended "prominent language to describe the risk of overdose in children."

According to the report, there is little evidence these medications are effective in young children, and they have come into question because of the deaths of at least 54 children taking decongestants and 69 taking antihistamines from 1969 to 2006.

FDA on Oct. 18 will hold an advisory committee hearing that will address the safety and effectiveness of OTC cough and cold medications in children younger than six (California Healthline, 10/11).

The recall, which includes medicines manufactured by Wyeth, Johnson & Johnson and Novartis, "represented a pre-emptive strike by over-the-counter drug manufacturers" and does not include products marketed for use in children older than age two, according to the AP/Los Angeles Times (Neergaard, AP/Los Angeles Times, 10/12).

Smaller companies could decide to continue selling medicines for young infants.

Consumer Healthcare Products Association President Linda Suydam said that manufacturers are withdrawing the products because "there have been rare patterns of misuse leading to overdoses recently identified, particularly in infants" (Harris, New York Times, 10/12). Suydam said, "These medicines are -- and always have been -- safe at the recommended doses," adding, "These voluntary actions are being taken out of an abundance of caution" (Washington Post, 10/12).

Baltimore Health Commissioner Joshua Sharfstein, who petitioned FDA to stop the sale of OTC cough and cold medicines to children under age six, said, "This is a good step -- not enough, but it's a good step" (Girion/Chang, Los Angeles Times, 10/12). Sharfstein said, "The problem with these products is there is no evidence that they're safe or effective, so doctors have no basis for deciding what safe and effective use may be" (Iwata, USA Today, 10/12).

Arthur Levin, director of the Center for Medical Consumers, said that while a recall might be described as voluntary, "it's often not so voluntary." Levin added, "At this point," manufacturers are "worried about their exposure to liability. There's a level of concern that can't be ignored anymore." Levin also noted that the industry might hope that the voluntary recall would limit the criticism of the drug industry and stop FDA from issuing a ban on all cough and cold medicines for children up to age six (Desmon/Emery, Baltimore Sun, 10/12).

Several broadcast programs recently reported on the voluntary recall. Summaries appear below.

• ABC's "Good Morning America": The segment includes a discussion with ABC medical editor Tim Johnson ("Good Morning America," ABC, 10/12). Video of the segment and expanded ABC news coverage are available online.
• American Public Media's "Marketplace": The segment includes comments from Sharfstein, Suydam and a parent (Hobson, "Marketplace," American Public Media, 10/12). Audio and a transcript of the segment are available online.
• CBS' "Evening News": The segment includes comments from Peter Lurie of Public Citizen and pediatrician Barney Softness (Andrews, "Evening News," CBS, 10/12). Video of the segment and expanded CBS News coverage are available online.
  
• CNN's "Newsroom": The segment includes a discussion with CNN chief medical correspondent Sanjay Gupta (Collins, "Newsroom," CNN, 10/11). A transcript of the segment is available online.
  
• NBC's "Nightly News": The segment includes comments from Lurie and a parent (Bazell, "Nightly News," NBC, 10/11). Video of the segment is available online.
  
• NPR's "All Things Considered": The segment includes comments from Virginia Cox, a CHPA vice president, and Sharfstein, (Aubrey, "All Things Considered," NPR, 10/11). Audio of the segment is available online.
  
• NPR's "Day to Day": The segment includes a discussion with Slate columnist and pediatrician Sydney Spiesel (Cohen, "Day to Day," NPR, 10/11). Audio of the segment is available online.