Cold Medicines for Infants Pulled From the Shelves

(CNN) -- The makers of several leading over-the-counter cold medications are voluntarily withdrawing products sold for infants, the Consumer Healthcare Products Association said Thursday.

The trade group said the products were being withdrawn "out of an abundance of caution" and insisted the products are safe when used as directed.

"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," Linda A. Suydam, the association's president, said in a statement.

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

CVS stores planned to stop selling the withdrawn products and store-brand equivalents, it said. Refunds are being offered if customers return the products.

Last month, federal health officials recommended that the "consult your physician" advice to parents on the labels of cold and cough medicines aimed at young children be dropped and a warning not to use the medications in children under 2 be added. The U.S. Food and Drug Administration will officially consider revising the labels at a meeting next week.

After reviewing reports of side effects over the last four decades, the 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.

Baltimore health commissioner Dr. Joshua Sharfstein and other health officials in Maryland had requested a review by the FDA, saying 900 children under four in Maryland had overdosed on the products in 2004.

"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," Sharfstein told The Associated Press on Thursday.

Consumer Healthcare Products Association is a trade group representing U.S. manufacturers and distributors of over-the-counter medications and nutritional supplements.

The withdrawal does not affect medicines intended for children ages 2 and older.

The association said it would back any FDA move to change the advice on oral children's cough medicine.

CNN's Dr. Sanjay Gupta said over-the-counter cold medicines can cause side effects such as sedation, irritability, allergy and heart abnormalities.

Instead of the drugs, Gupta said, parents of sick infants can use vaporizers or hydrators, saline nose drops, rubber nose bulbs, and chicken soup and other fluids to keep an infant hydrated.

Withdrawn Medicines Are

Dimetapp
Decongestant Plus Cough Infant Drops
Decongestant Infant Drops

Little Colds
Decongestant Plus Cough
Multi-Symptom Cold Formula

Pediacare
Infant Drops Decongestant (containing pseudoephedrine)
Infant Drops Decongestant & Cough (containing pseudoephedrine)
Infant Dropper Decongestant (containing phenylephrine)
Infant Dropper Long-Acting Cough
Infant Dropper Decongestant & Cough (containing phenylephrine)

Robitussin
Infant Cough DM Drops

Triaminic
Infant & Toddler Thin Strips Decongestant
Infant & Toddler Thin Strips Decongestant Plus Cough

Tylenol
Concentrated Infants' Drops Plus Cold
Concentrated Infants' Drops Plus Cold & Cough


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