Nonprescription Cough and Cold Medicine Use in Children - Overview
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Welcome to the Food and Drug Administration's drug safety update.
I am Ayse Yeaton from F-D-A's Center for Drug Evaluation and Research.
On August 15, 2007 we issued a public health advisory regarding a Nonprescription Cough and Cold Medicine Use in Children in connection with an announcement that, in October, FDA will hold an Advisory Committee meeting to discuss the safety and effectiveness of using these products in children.
Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age.
In preparation for the meeting, we are reviewing safety and efficacy data for the ingredients of these products. In the meantime, our public health advisory discusses what parents should know about using cough and cold products in children.
To hear the full public health advisory, listen to part two of this broadcast.
We urge both healthcare providers and patients to report side effects from medical products to the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot G-O-V slash M-E-D-W-A-T-C-H.
Date created: August 16, 2007; updated August 17, 2007