Advisory committee to consider safety of cough and cold drug use in children.FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. announced that on Oct. 18-19, the Nonprescription non·pre·scrip·tion
Sold legally without a physician's prescription; over-the-counter. Drugs Advisory Committee will discuss the safety and effectiveness of cough cough, sudden, forceful expiration of air from the lungs caused by an involuntary contraction of the muscles controlling the process of breathing. The cough is a response to some irritating condition such as inflammation or the presence of mucus (sputum) in the and cold drug product use in children, the agency stated Aug. 15.
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 two years of age.
In preparation for the meeting, FDA is reviewing safety and efficacy data for the ingredients of these products.
Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. are being used.
To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the "Drug Facts" box on the package label. The Public Health Advisory offers parents and caregivers of children recommendations when using cough and cold products in children.
Read the complete MedWatch MedWatch is the Food and Drug Administration’s reporting system for adverse events. An adverse event is any undesirable experience associated with the use of a medical product. 2007 Safety summary, including a link to FDA Public Health Advisory and Federal Register Meeting Notice regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safetyO7.htm#Cough.