FDA Supports Drug Makers 4-Year-Old Limit for OTC Cough and Cold Medicines

In a statement released yesterday, the FDA notified healthcare providers and consumers that it supports the recent decision by the drug industry to change the warning labels for over-the-counter (OTC) cough and cold drugs to indicate that they should not be used by children under 4.

On October 7, 2008, the Consumer Healthcare Products Association (CHPA) announced that nonprescription children’s OTC cough and cold drugs will contain new product labels that indicate “do not use” in children under 4 years old. In addition, the drug makers will be adding new child-resistant packaging and new dose measuring devices to help reduce the risk of misuse or accidental overdose.

Although many pediatricians and consumer advocacy groups have called for a ban on the use of OTC cough and cold drugs by all children under 6, the FDA has indicated they support the drug makers’ voluntary action at this time.

The FDA is continuing to assess the safety and effectiveness of these drugs, including the list of approved ingredients and amounts. Two public meetings have been held by the FDA, one in January that recommended not using the drugs for children under 2 and the latest on October 2, 2008, which focused on product labeling.

In their statement released on October 8, 2008, the FDA indicated that there will not be a recall of children’s cough and cold drugs currently on store shelves. Therefore, there will be a transition period where instructions for some of the OTC drugs will indicate they should not be used by children under 2 and others will indicate “do not use” for children under 4.

Popular children’s versions of OTC cough and cold drugs, such as Tylenol, Pediacare, NyQuil, Dimetapp and Triaminic have been associated with reports of potentially serious side effects, such as hallucinations, rapid heart beats, suppressed respiratory systems, strokes and seizures.

 
Over 7000 children are admitted to emergency rooms every year for treatment of side effects from children’s OTC cough and cold drugs. The majority of these cases involve children who are 2 or 3 years old.

The FDA has stressed that parents and caregivers should never give a child medication that is labeled for an adult, and they should carefully adhere to the dosage instructions and warnings on the labels of all medications.