Drugmakers recall infant cough and cold medicine

ByABC News
October 11, 2007, 4:34 PM

— -- After federal regulators and private doctors warned of potential health risks to kids, drug companies said Thursday that they will voluntarily withdraw over-the-counter, cough-and-cold medicines for infants and toddlers under 2.

After federal regulators and private doctors warned of potential health risks to kids, drug companies said Thursday that they will voluntarily withdraw over-the-counter, cough-and-cold medicines for infants and toddlers under 2.

The withdrawal does not include cold and cough medicines for children over 2 years of age, even though medical experts have warned that the medicines could pose health risks to children up to 6.

Linda Suydam, president of the Consumer Healthcare Products Association, which represents the drugmakers, said the medicines are safe and effective when used as directed, and that "the vast majority of parents and caregivers" use them appropriately.

But she added that "there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."

The companies and their subsidiaries involved in the withdrawals have posted information on their websites.

Product labels currently recommend that parents "ask a doctor" before giving the medicine to babies and toddlers. The Food and Drug Administration and the CHPA now recommend that the labels be strengthened to read "do not use" for children under 2.

The FDA will discuss officially changing the labeling during public meetings with health experts on Oct. 18 and 19th.

The medicines have come under heightened review by federal regulators and medical authorities in recent months.