FDA Committees Recommend Ban on Cough and Cold Medications for Young Children

October 24, 2007
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

After a whirlwind of negative press this fall regarding the safety of cough and cold medications for children under age 6, the US Food and Drug Administration?s Nonprescription Drugs and Pediatric Advisory Committees have recommended such over-the-counter drugs no longer be used for young children.

Rockville, MD (Oct. 18–19)-After a whirlwind of negative press this fall regarding the safety of cough and cold medications for children under age 6, the US Food and Drug Administration’s Nonprescription Drugs and Pediatric Advisory Committees have recommended such over-the-counter drugs no longer be used for young children.

The news came after the Baltimore City Health Department, among other health and pediatric groups, filed a petition requesting that FDA not allow cold and cough medications to be marketed to children younger than 6. Also, on Oct. 12, Wyeth, Novartis, Prestige Brands, and Johnson & Johnson, pulled their cough and cold medications for children under age 2 off the market in a preemptive move (see full story here).

The committees based their recommendation on the fact that cough and cold medications for use in children have not been proven effective, according to current published research. Because there is potential for other adverse effects to occur with these drugs, the committees felt that their use should be limited. There have been cases, including death, in children under age 6 with these types of medications, according to FDA; overdosing is the most common factor.

Specifically, the committees voted unanimously that cough and cold medications should not be used in children under age 2, and voted 13–9 against children between the ages of 2 and 6 taking the medications. Seven of the 22 panel members voted against the drugs’ use in children aged 6–12. All of the panel members agreed that cough and cold medications have yet to be proven effective in children under age 12.

Committee members further recommended that manufacturers undertake more clinical effectiveness studies for drugs in children, and that those studies test the ingredients of products separately. Cough frequency and relief of nasal symptoms were some of the suggested trial endpoints.

Although FDA agreed that cough and cold medications have not been shown to be effective in children, the agency said it was important to consider that current studies were not well designed. FDA typically accepts advisory committee recommendations, but is not required to do so. Withdrawal of these medications could take years.
 
In a related topic, the advisory committees discussed dosing devices for children’s medications, unanimously suggesting that devices be required and standardized using volume measurements for liquid formulations.

To read FDA’s original advisory on cough and cold medications, click here.