FDA MedWatch - Nonprescription Cough And Cold Medicine Should Not Be Used For Children Under 2 Years Of Age]

FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue.  

Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory and a previous MedWatch alert dated January 12, 2007, regarding this issue.

http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough

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FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue.

Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory and a previous MedWatch alert dated January 12, 2007, regarding this issue.

http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) . 5600 Fishers Lane . Rockville MD 20857 . 800-439-1420