Over The Counter Cough and Cold Medications

FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.
Source: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01899.html

Cough and Cold Medications in Children Less Than Two 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.

Source: http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm

FDA Advisory Committees Recommend Against Cough and Cold Medications in Children Under 6

Citing a lack of proven effectiveness and a need for clinical trials in children, the FDA’s Nonprescription Drugs and Pediatric Advisory Committees recommended the ingredients in cough and cold medications not be used in children younger than 6.

The agency convened a two-day meeting in response to a citizen petition requesting the FDA not allow the drugs to be marketed for children younger than 6. The petition was filed by the Baltimore City Health Department on behalf of several hospitals and universities. Although the petitioners’ request applies to children younger than 6, the agency told the committees any actions it takes could apply to children younger than 12.

The FDA is not required to accept advisory committee recommendations but usually does. Petitioners testifying to the committees argued, based on review of published studies, that cough and cold products intended for use in children have not been proven effective. Therefore, any adverse events associated with their use in the respective patient populations are not appropriate, and use of the drugs in children should be limited.The FDA agreed that the drugs have not been shown to be effective but said it was important to consider the studies were not well designed. If the agency were to act on the advisory committees’ recommendations, it would have to start the rulemaking process.

The panel voted unanimously that the products should not be used in children younger than 2 and voted 13-9 against use in those between the ages of 2 and 6. The committees did not recommend against use of the drugs in children between the ages of 6 and 12, with seven members voting to ban it and 15 not to. However, the members voted unanimously that cough and cold medicines have not been shown effective in children younger than 12.

Source: http://news.google.co.in/news?hl=en&ned=in&q=FDA

Nonprescription Cough and Cold Medicine Use in Children

FDA announced that on October 18 - 19, 2007, the Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use 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 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 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.

Complete Advisory: http://www.fda.gov/cder/drug/advisory/cough_cold.htm