A Food and Drug Administration advisory panel voted last month to ban popular over-the-counter cold products intended for children under the age of 6.
The panel found there was no proof that the medicines eased cold symptoms in children, while there are rare reports that they have caused serious harm.
If put into practice, the ban will have a drastic effect on the way parents cope with the most common illness in young children.
These products are now available without a medical doctor or pharmacist being involved in any manner.
The vote came a week after major manufacturers agreed to withdraw more than a dozen cold products labeled for use in infants and babies. But, never doubt that manufacturers won’t fight the new recommendations.
If the agency decides to adopt the committee’s recommendation, it must undertake a rule-making process that can “take anywhere from one to many years,” according to Dr. Jenkins, director of the office of new drugs at the FDA.
The products under review include such common brand names as PediaCare, Robitussin and Triaminic, which are made, respectively by Johnson & Johnson, Wyeth and Novartis. It’s significant that some of these products are directly marketed for infants and other children under 6.
There are currently about 800 pediatric cold products sold in the United States that use one or more of 39 different drugs. Parents spend around $500 million every year buying nearly 95 million boxes containing 3.8 billion doses of medicine.
The panel voted by a 15 to 7 vote to allow the continued marketing of medicines intended for children 6 and older.
It voted unanimously to require standard measuring devices with products to cut down on accidental overdoses.
The panel also voted that no product should be allowed to market itself as “doctor recommended,” a common marketing ploy now being used that many panelists felt is misleading.