Drugmakers recall infant cough and cold medicine

— -- 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The medicines being withdrawn include: Johnson & Johnson's jnj Pediacare Infant Drops and Infant Dropper and Tylenol Concentrated Infants Drops; Wyeth's WYE Dimetapp Decongestant Infant Drops and Robitussin Infant Cough Drops; Novartis' nvsTriaminic Infant & Toddler Thin Strips and Prestige Brands Holdings' Little Colds Decongestant Plus Cough and Multi-Symptom Cold Formula.

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.

In September, FDA safety researchers strongly recommended that their agency ban over-the-counter, cough-and-cold medicines for children.

The researchers found that 54 children had died from 1969 to 2006 after taking kids' medicines that use the ingredients ephedrine, pseudoephedrine and phenylephrine. The FDA also found that 69 deaths of children were linked to antihistamines that contained diphenhydramine, brompheniramine and chlorpheniramine.

Most of the children who died were under 2, and the FDA said that the medicines haven't been proven to work in little kids.

Earlier research by the Centers for Disease Control and Prevention found that 1,500 children under 2 had suffered serious health problems after using cough-and-cold medicines.

Private physicians and the American Academy of Pediatrics also have warned that many kids' cough-and-cold products are not safe or effective for children under 6.

One medical critic of the drug industry cautioned that parents cannot assume the medicines are safe even when used as instructed, as the CHPA claims.

"When it comes to children under age two there are no recommended doses on these products so it's not reasonable to claim they are safe and effective when used as directed," Joshua Sharfstein, a physician and Baltimore's health commissioner, told the Associated Press.

Sharfstein alerted the FDA about the potential health threat of cold medicines after Baltimore city officials found that 900 children under 4 in Maryland had overdosed on the products in 2004, according to the Associated Press.