FDA safety reviewers want warnings on cold medicines for kids.

Cold and cough medicines shouldn't be used by children under 2 and should carry warnings that they can cause fatal overdoses in young children, agreed both FDA safety experts and makers of the drugs, Bloomberg reported Sept. 27.

FDA reviewers say an educational campaign should be started to alert parents that nonprescription cold medicines can lead to fatal overdoses and other side effects in young children. Between 1969 and Sept. 13, 2006, 54 children, most less than 1 year old, died from taking cold preparations with decongestants, the reviewers said in a report posted on the agency's Web site.

The report was posted in advance of a meeting Oct. 18-19 of agency advisers as regulators try to find out why children are overdosing and suffering harmful side effects. Questions to be discussed at the meeting include whether the drugs actually help sick children, whether they're safe for them and whether recommended doses on packages need to be changed. The results could lead to limits on sales.

"There is a lot of data in adults showing these medicines are effective, but the question is whether this applies to children," said Joel Schiffenbauer, deputy director of FDA's office of nonprescription products, in a telephone interview with Bloomberg.

U.S. sales of non-prescription cough and cold remedies totaled $3.63 billion for the 12 months through Jan. 27, according to AC Nielsen, a New York-based market research company. Sales of children's remedies totaled $284 million. The numbers do not include sales from Wal-Mart, the world's largest retailer.

The Consumer Healthcare Products Assn., which represents makers of non-prescription drugs, said in a document submitted to FDA that it concurred with the key recommendations made by agency staffers.

"We recommend that the label be changed in all OTC cough and cold medicines to read 'Do Not Use'" in children under 2 years of age, the CHPA document said.

Makers of cold preparations for children include Wyeth, Johnson & Johnson and Procter & Gamble. More than 800 cough and cold treatments, including formulations intended for children, are available in the U.S., the agency report said.

The upcoming committee meeting and the agency review were prompted by a citizen's petition submitted to FDA in March by a group of prominent pediatricians, including Baltimore's Commissioner of Health, Joshua M. Sharfstein. The doctors say the drugs are unsafe and ineffective and asked the agency to prevent marketing of the products to children younger than 6 years.

In 2004 and 2005, an estimated 1,519 children under 2 were treated in U.S. emergency rooms because of harmful reactions to the drugs, according to a report in January from the U.S. Centers for Disease Control in Atlanta.

The agency could take a number of different actions, including recommending that children of certain ages not take the medicines or requesting studies by drug makers, Schiffenbauer said. Studies in young children would be hard to orchestrate because "children in that age group would have trouble expressing how their symptoms have been affected and how they feel," he said.

The briefing document can be found at:: http://www.fda.gov/ohrms/dockets/ac/07/briefing/20 07-4323b1-02-FDA.pdf