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

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Info for list members with children.

Regards .

---------- Forwarded message ----------

From: U.S. Food & Drug Administration (FDA) <fda@...>

Date: 17 Jan 2008 17:09

Subject: FDA MedWatch - Nonprescription Cough And Cold Medicine Should Not

Be Used For Children Under 2 Years Of Age

racemedical@...

[image: MedWatch logo] [image: MedWatch - The FDA Safety Information and

Adverse Event Reporting Program]

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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Dr.J.Sullivan