In January, the FDA warned against giving over-the-counter cough and cold medicines to children less than 2 years of age. Officials said at the time that they planned to release recommendations covering children up to age 11. Later, experts retained by the FDA voiced concerns about the efficacy of OTC drugs in kids between the ages of 2-6, but the FDA issued no further warnings.
Instead, the FDA held hearings on the matter last week. Pediatricians in attendance called for a ban on use of the drugs in children. They noted there is no evidence that they work in children and they prompt 7,000 ER visits each year due to side effects and overdoses from active ingredients such as decongestants.
John Jenkins, the FDA’s new drug director, rejected calls for the ban. Parents would simply give adult-strength versions of the same drugs to their kids, he said, adding “We don’t see a public health emergency here as far as an inherent risk of the products.”
Jenkins then said the FDA would make no recommendations on the matter for years to come.
US families spend $300 million per year on OTC cold remedies for children. In any given week nearly 10% of US children receive them. Utilization is highest among kids aged 2-5 years. Novartis (Triaminic), Johnson & Johnson (Tylenol Plus Cold) and Wyeth (Robitussin) all play in the market for OTC remedies to children. They voluntarily halted marketing to babies and toddlers even before the FDA’s January warning, but claim the medicines are safe for kids older than the age of 2.