Log In


Reset Password
Archive

Kid Cold Medicines Pulled Off Market While FDA Huddles

Print

Tweet

Text Size


Kid Cold Medicines Pulled Off Market While FDA Huddles

WASHINGTON. D.C. (AP) — Drug makers on October 18 voluntarily pulled kids’ cold medicines off the market less than two weeks after the government warned of potential health risks to infants.

Products aimed at children under the age of 2 are being removed from store shelves due to “rare instances of misuse” that could lead to accidental overdose, a trade group that represents over-the-counter drug makers said.

Cold medicines being withdrawn include: Johnson & Johnson (JNJ) Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth’s Dimetapp Decongestant Infant Drops, Novartis’ Triaminic Infant & Toddler Thin Strips, and Prestige Brands Holdings’ Little Colds Decongestant Plus Cough.

CVS Caremark Corp said that day it would remove the affected products as well as CVS-brand equivalents from store shelves.

Late last month the Food and Drug Administration tentatively recommended adding the words “do not use in children under two years” to product labeling. Current labeling directs parents to consult a doctor before administering the drugs to infants and toddlers. Government scientists also said there is little evidence that cold medicines actually work in younger children.

FDA representatives were formally considering revising labeling at a meeting scheduled for October 19.

At that meeting, an American Academy of Pediatrics official told government health advisers cold and cough medications should be relabeled to tell parents they don’t work in children under 6 and may be dangerous.

“Why not label these products with what we actually know?” Frederick, Md., pediatrician David Bromberg told the panel of Food and Drug Administration advisers.

The proposal was just one of many being considered by the outside experts, convened by the FDA, to determine whether the widely used over-the-counter medicines are safe and work in young children. Among the other proposals include an outright ban in marketing the medicines for use in young children and more study of their safety and efficacy in treating colds and coughs.

The panel also is being asked to examine whether the dizzying array of medicines that combine multiple ingredients and the sometimes hard-to-use droppers included in the packaging contribute to parents unwittingly overdosing their children. Some in the FDA recommend doing away with the combo products and requiring better-designed and standardized dosing devices.

After reviewing reports of side effects over the last four decades, FDA found 54 child fatalities from over-the-counter decongestant medicines. The agency found 69 reports of children’s deaths connected with antihistamines, which are used to treat runny noses.

The Consumer Healthcare Products Association, which represents drug makers, said it will conduct a multiyear campaign to educate parents and physicians on safe use of cold medicines.

The trade group stressed in a statement that the “medicines are, and have always been, safe at recommended doses.”

However, industry critics challenged this statement.

“When it comes to children under age 2 there are no recommended doses on these products so it’s not reasonable to claim they are safe and effective when used as directed,” said Dr. Joshua Sharfstein, Baltimore’s health commissioner.

FDA is reviewing the safety of cold medicines at the request of Baltimore city officials, who reported 900 Maryland children under 4 overdosed on the products in 2004.

Comments
Comments are open. Be civil.
0 comments

Leave a Reply