OTC Infant Cough Cold Meds Pulled

Posted by Kathy Quan Oct 12, 2007

Last week the FDA announced it was going to hold a hearing to determine if stronger warning labels were needed on children's OTC cough and cold medicines in response to a number of deaths from misuse. The FDA advisory committee meeting will take place October 18 and 19, 2007 for further evaluation of the safety of children's cough and cold medicines.

The Consumer Healthcare Products Association (CHPA) announced on behalf of the leading makers of children's OTC cough and cold medicines that they were voluntarily withdrawing all infant formulas for theses medications. The formulas of these cough and cold medicines for children over 2 years of age remain available.

The voluntary withdrawal of these medications was made to prevent further misuse of the medications, not because the medications are unsafe or tainted.

The CHPA and its members have recommended to the FDA stronger labeling for these formulas to state "do not use" instead of "ask a doctor" for children under the age of two. They also announced that they will be launching a major parent education campaign to educate parents and healthcare providers in the safe use of their OTC products.

One of the major issues the FDA and CDC found in the reported deaths of children from these medicines was misuse. Children were given multiple doses of the same medication and, in effect over dosed, because when one brand name product didn't seem to work, another brand was given before the recommended 4-6 hours was up.

Consumers need to read OTC labels for active ingredients. Most OTC medications contain the same ingredients. Using a different brand name product doesn't give you a different medication. Make informed choices and practice safe medication administration. If you have questions, ask your PCP or pharmacist FIRST!