The concerns about cough-and-cold meds for kids [1] culminated Friday in an FDA advisory group vote against the products. The expert group concluded that there's not enough evidence that the drugs work--and plenty of evidence that they can be harmful--so they shouldn't be used in children under the age of 6.
The 13-to-9 decision was by no means unanimous, though. Some panelists believe parents depend on the drugs for help when a child is sick. Americans spend more than $300 million a year on these products. The agency probably will work with the industry to come up with a voluntary action plan, because formal proceedings could take years, FDA officials told the Washington Post.
- read the report [2] from the Washington Post
Related Articles:
FDA experts mull ban on child cold meds. Report [1]
Drug makers recall infant cold meds. Report [3]
FDA to review OTC cough medicine safety. Report [4]
Links:
[1] http://www.fiercepharma.com/story/fda-experts-mull-ban-on-child-cold-meds/2007-10-19?utm_medium=nl&utm_source=link
[2] http://www.washingtonpost.com/wp-dyn/content/article/2007/10/19/AR2007101900246.html
[3] http://www.fiercepharma.com/story/drug-makers-recall-infant-cold-meds/2007-10-11
[4] http://www.fiercepharma.com/story/fda-to-review-otc-cough-medicine-safety/2007-08-16?utm_medium=nl&utm_source=link