Some children’s medicines being voluntarily withdrawn

10/11/2007

Makers of OTC remedies targeted at those younger than 2 have elected to pull them off the market after a pattern of overdosing is identified.


By Lisa Girion,
Los Angeles Times
October 11, 2007


The makers of over-the-counter oral cough and cold medicines that are targeted to "infants" -- those younger than 2 -- began voluntarily pulling the medications off the market today because of concerns about overdosing, an industry group said.

CVS Pharmacy also announced that it would clear them from its shelves.

The move follows a review by the U.S. Food and Drug Administration that found it had received 54 reports of children's deaths from decongestants and 69 from antihistamines between 1969 and 2006, most of them younger than 2.

FDA staff had recommended new label instructions for over-the-counter cough and cold medicines containing decongestants and antihistamines, including a warning against their use on young children.

The agency was set to consider that recommendation, as well as those of outside advisors, later this month.

The Consumer Healthcare Products Assn. said the voluntary market withdrawal affected only the "infant" oral medicines, not those intended and labeled for use in children ages 2 and older.

"It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," association president Linda A. Suydam said 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."

According to the association, infant cough and cold medicines under the following brands are being voluntarily withdrawn: Dimetapp, Little Colds, PediaCare, Robitussin, Triaminic and Tylenol.

The industry group said that it and its member companies had made recommendations to the FDA to strengthen the labels on all oral over-the-counter children's cough and cold medicines from "ask a doctor" before using to "do not use" in children younger than 2.

An FDA advisory committee is set to consider the issue, including the recommendations of its staff, at an Oct. 18 meeting.

"These medicines are -- and always have been -- safe at recommended doses," Suydam said.

The association said the companies elected to take the medications off the market out of an abundance of caution. It said most parents and caregivers safely use these medicines to help relieve their children's symptoms.

The group also said it would launch a campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children.