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Canadian health officials call for relabeling of cough-cold remedies


OTTAWA Health Canada on Thursday announced that manufacturers will need to re-label over-the-counter cough and cold medicines that have dosing information for children to indicate that these medicines should not be used in children under the age of six. The decision came after Canada’s drug regulatory agency reviewed the category and could be a preview of what might be in store in the United States—the Food and Drug Administration is expected to announce any proposed changes to monographs governing seven key over-the-counter cough/cold ingredients used in pediatric formulations in September of 2009.

The re-labeling of these medicines will be completed by fall 2009, in time for the next cough and cold season, the Canadian agency stated. “During the current cough and cold season, medicines will remain on store shelves and in homes with the current labelling, which could include dosing information for children under six, because many of these products also have dosing information for adults and older children on the same label. As a result, for this cough and cold season, parents or caregivers should consult a pharmacist or a health care practitioner when buying or using these products,” the agency  said.

“Health Canada has concluded that while cough and cold medicines have a long history of use in children, there is limited evidence supporting the effectiveness of these products in children,” the agency added. “In addition, reports of misuse, overdose and rare side-effects have raised concerns about the use of these medicines in children under six.”

“Families have relied on cough and cold medicines to comfort their children for more than 30 years,” said Bill Murphy, vice president OTC, Latin America and Canada, McNeil Consumer Healthcare. “McNeil Consumer Healthcare has always encouraged the appropriate use of these medicines and these actions will further support parents and caregivers as they care for children with colds.”

“Children’s over-the-counter cough and cold medicines continue to be safe and effective when used as directed,” commented Linda Suydam, president of the Consumer Healthcare Products Association, in response to Health Canada’s decision. “Today’s decision by Health Canada has no impact on medicines in the United States,” she said.

“FDA has always taken a conservative approach when examining the risk-to-benefit ratio of medicines available in the United States. In October 2008, FDA indicated that its suggestion to U.S. manufacturers to re-label OTC childrens oral cough and cold medicines to read do not use in children under age four stems from a close look at all available data. In addition, the agency expressed its support of drug makers efforts to voluntarily modify directions advising parents not to use pediatric OTC oral cough and cold medicines in children under age four.”

Suydam referenced industry’s announcement in October to re-label all pediatric OTC cough/cold remedies sold in the U.S. not to be used in children under the age of four. That re-labeling is currently ongoing.

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