McNeil, Novartis, Prestige, Wyeth withdraw infant OTCs

FORT WASHINGTON, Pa. A full week before the Food and Drug Administration hosts a meeting regarding pediatric nonprescription medicines, McNeil Consumer Healthcare, Novartis Consumer Health, Prestige Brands and Wyeth announced Thursday morning that they are voluntarily withdrawing certain infants' cough-and-cold products from the market.

"This voluntary action by McNeil Consumer Healthcare is based on the company's longstanding commitment to the appropriate use of medications by parents and physicians," stated Ashley McEvoy, president of McNeil Consumer Healthcare. "McNeil Consumer Healthcare is committed to providing parents with safe and effective over-the-counter medications that treat their child's cough-and-cold symptoms. In addition to taking this voluntary action, McNeil Consumer Healthcare, along with our industry partners, supports the Consumer Healthcare Products Association recommendations that were recently submitted to the Food and Drug Administration. These recommendations include label changes to OTC cough-and-cold medicines advising 'do not use' in children under 2 years of age. Our voluntary action in removing [these] products from the market is consistent with these recommendations."

"It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," stated Linda Suydam, president of the Consumer Healthcare Products Association. "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."

In preparation for FDA’s meeting on pediatric nonprescription medicines next month, CHPA and its member companies last week posted recommendations to the FDA to strengthen the labels on all oral OTC children’s cough-and-cold medicines from "ask a doctor" before using to "do not use" in children under 2 years old.

"These medicines are—and always have been—safe at recommended doses," Suydam said. "These voluntary actions are being taken out of an abundance of caution. The vast majority of parents and caregivers safely use these medicines to help relieve their children’s symptoms. But as with all medicines, it’s important that parents read over-the-counter medicine labels carefully, use these medicines only as directed, and store them safely out of the reach of children."

CVS announced this morning that it would be removing all oral over-the-counter infant cough-and-cold medicines from its shelves. A block also is being placed in the point-of-sale system to prevent sales of these items. The company stated that customers who purchased any of these items at CVS/pharmacy may return them for a full refund.

"The health and safety of our customers and their children is our highest priority," said Mike Bloom, senior vice president of merchandising at CVS/pharmacy.

CHPA will soon be launching a major, multiyear national campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children, partnering with major physician, nurse and pharmacist organizations.

CHPA issued a moratorium on advertising nonprescription medicines to children under the age of 2 last week, following a letter criticizing the industry from Rep. Henry Waxman, D-Calif. “CHPA’s member companies are no longer advertising or promoting these medicines for infants and are individually working on their own transition plans to address the recommendations put forth in our background materials for the upcoming FDA advisory committee meeting,” stated Elizabeth Funderburk, CHPA director of communications and media relations, last week.

Waxman released a letter addressing CHPA’s pending public comments on the labeling of pediatric cough-and-cold products before an FDA advisory committee meeting to be held Oct. 18 and 19.

Waxman criticized CHPA’s advocacy of a ban on marketing products to children under the age of 2 even as several CHPA members have products on the market targeting infants.

The brands that are part of the collective voluntary recall include exclusively products marketed to children under the age of 2, including Dimetapp, Little Colds, Pediacare, Robitussin, Triaminic and Tylenol. Cough-and-cold products for children age 2 and over and single-ingredient pain reliever/fever reducers expressly labeled for infants are not included in this voluntary withdrawal, McNeil stated.

Click here for a larger version of the graphic.