• by Karl Greenberg , October 12, 2007

Drugmakers and at least one pharmacy chain are pulling cough medicines for children from the shelves in wake of the Food and Drug Administration's decision to review rules after reports of unintentional overdoses.

CVS/pharmacy, the retail division of CVS Caremark, says it will remove the products from its stores, including CVS-branded equivalents. Manufacturers have pulled the medicines and created micro sites on their consumer Web sites explaining the issue. At least one has launched a Web campaign. Medications that are being sidelined include Dimetapp decongestant and cough drops for infants; Little Colds decongestant and cough formulas; Pediacare; Robitussin; Triaminic; and Tylenol.

OTC industry trade group Consumer Healthcare Products Association is calling for voluntary recall of oral over-the-counter infant cough and cold medicines. The group says it will launch a multi-year national campaign to educate parents and health-care providers about how to safely use OTC medicines in children.

The group says the products were being withdrawn "out of an abundance of caution," and insists the products are safe when used as directed. "It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," says Linda A. Suydam, president of CHPA, in a statement. "The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."

McNeil PPC, Inc., which makes PediaCare and Tylenol brands, has launched a banner ad campaign explaining the recall and offering a toll-free number. Novartis Consumer Health, which makes Triaminic, and Wyeth Consumer Healthcare, which makes Robitussin and Dimetapp, have notices on their sites.

The moves come after criticism from several quarters about cold and cough formulas for infants. The FDA, which determined that 54 children (most under the age of 2) had died from OTC medications and 69 from antihistamines since 1969, suggested that the industry replace the "consult your physician" notices on cold and cough medicines for young children. The agency instead advocates a warning that the medicines should not be used in children under 2. The FDA reportedly arrived at its conclusion and recommendations after reviewing 40 years of agency records in a study of some 800 cold medicines.

The FDA will meet on Thursday to consider ruling that labels must be revised. Drug companies already are doing so. Wyeth says it is changing labels on Robitussin and Dimetapp to advise doctors and parents: "Do not use in children under two years of age."